The CECON Connection

Carbon Capture Options

2016-07-14T13:03:00.001-04:00

There have been recent articles about “CarbFix, a pilot program at Iceland’s Hellisheidi Geothermal Power Station utilizing carbon capture and storage (CCS). CO₂ gas is pumped underground and leads to its transformation to minerals. This process eliminates the concern for underground storage sites that will remain stable for a long period of time (i.e. no earthquakes or geological faults are going to occur: any rupture of underground storage layers would lead to catastrophic release of CO₂ that affects the biomass near surface layers.)

Along with this single advantage come a few issues to consider with this approach, including its broader applicability:

(i) The geology of the Icelandic underground reserve. The process is intrusive to the natural balance. Per literature estimates, 1 million ton of CO₂ would require 1 km³ of basalt reserve.

(ii) According to literature and assuming the underground storage facility is at the right temperature to ensure fast kinetics per the article claim, a pressure of 200 to 400 bar might be required to drive the storage process. Formation of carbonates might even make seeping of carbonated water more difficult. How many kgs of CO₂are released to atmosphere by large capacity pumps per ton of CO₂ sequestered underground per cubic meter of Basalt? (This question is moot if the pumps operate using hydrothermal power).

(iii) Water requirements. What volume of Icelandic water is required to dissolve 1 ton of CO₂ gas where the pH of the water is a crucial factor in getting the maximum dissolution of CO₂gas? If the process uses saline water or seawater, then implications to underground mineral water contamination have to be considered.

(iv) The process is localized to the Icelandic territory. Most coal fired power plants or other CO₂emitting industrial facilities do not have the advantage of an underground basalt reserve, which became transformed to their present state from other minerals that already lost their CO₂ content due to thermally elevated conditions above ground or underground.

Compared to other carbon capture and conversion processes (i.e. Carbon Capture and Mineralization (CCM) or Carbon Capture and Utilization (CCU)), the Icelandic project is expected to handle a much greater quantity of CO₂ conversion at a minimum power loss. There are few industrial CCM and CCU processes that are either under pilot test or production stage that claim CO₂ capture. If these facilities are powered by fossil fuel, then these cannot claim any carbon capture. Examples of these CCM/CCU processes are modified Solvay, Chlor-alkali, urea, polymerization, pilot electrochemical processes, and others. The major advantage over the CCS basalt project is that the end products are usually commodity chemicals used for commercial purposes. Finally, one process that uses membrane/ion exchange technology to process alkaline waste from industrial sites can compete with CCS basalt project in terms of energy and chemical byproducts.

Another trend that is getting serious consideration by scientists around the world is CO₂ gas conversion to carbon monoxide (CO) gas and other basic precursors heavily used as start-up chemicals in chemical industry. That is, recycle CO₂ gas instead of losing it to underground storage. A major hurdle in this regard is energy consumption, and scientists are searching for a breakthrough. A multibillion dollar CCU recycle process that is not CCM can have a major contribution to CCS technology at the global scale with world geopolitics. However, this topic will require a separate discussion.

The author of this blog post has a Ph.D. in Analytical Chemistry and is the inventor in 10 patents. His experience includes research in carbon capture, cartridge membrane mineral concentrators, semiconductor, metal, and ceramic surface cleaning and functionalization with surface coatings. Click to read more about this technical expert.

Since 1985, CECON has been placing experts in over 200 scientific disciplines. CECON Consultants also include Chemical Safety Experts, Nanotechnology Experts, FDA Regulatory Experts, and Polymers& Coatings Experts.

Hazard Identification: The Mitigation Hierarchy and Human Interface

2016-05-17T15:44:00.000-04:00

Hazard Identified; What Next?

As we’ve discussed in recent articles, once a hazard is identified as legitimate, it needs to be mitigated. A time-tested approach is what is known as The Industrial Hierarchy of Controls. While effective if applied properly, we must consider the human interface when utilizing the hierarchy of controls. A quick refresher of the hierarchy of controls will remind us that it is historically comprised of 4 components: Substitute/Eliminate, Engineer, Administrate and PPE. Depending upon what it is we’re trying to control, any one component could be effective, or a combination might be called for to mitigate the hazard.

Initially, when using the hierarchy, we would prefer to substitute or eliminate the hazard if possible. Eliminating is obviously the simpler action. Let’s say we have a board with protruding nails laying in a walkway. We don’t need the board for the completion of our task, so we simply remove the nails and discard or re-use the board, thus eliminating the hazard.

Now, let’s say we’ve been using a particular cleaning compound. A revised MSDS reveals that it contains a carcinogenic component in its composition. Not wanting to expose anyone to the chemical hazard, we now have to determine how to control that hazard. We need to use a cleaner in order to complete our task. The question now is, How? A bit of research finds that there are several other cleaners that perform as well, but they have no carcinogens in their composition. In this case we can opt to substitute a new, hazard-free cleaner for the old cleaner and complete the task as desired.

To Engineer a hazard control may take a group of professionals with specific skill sets. Depending upon how complex the hazard control may be, it’s possible that you may require certain experts in a particular field, or simply a creative individual with a practical solution. Using an example from my own work history, let’s solve an excessive noise issue. In a compressor building, we had monitored SPL’s of 121dba. That is loud by anyone’s standards! Even with double hearing protection, the long-term effects on workers were undesirable. Our solution needed to be the best in terms of long-term performance and protecting our employees. An assessment revealed that the manifold/muffler systems used on the 2-cycle, gas-burning engines produced a harmonic conducive to extreme sound levels at the RPM’s the engines operated at. After consulting with numerous specialists, the determination was to install new, quieter manifold/muffler systems on the engines and use sound-deadening, portable barriers during maintenance work. What we did was use a combination of substitute and engineer to control the hazard.

Sometimes, it’s a matter of removing people as opposed to removing a hazard, to arrive at the best solution for hazard control. During summer months when temperatures are highest (and employees working outside are most exposed to heat stress) many companies will arrange work schedules to compensate for the heat. It may simply be a matter of having employees arrive earlier in the day, or working later at night to remove them from the exposure to the hazard of heat stress. In this case, the best hazard control is administrative.
Finally, we arrive at what has been considered the last control in the hierarchy. PPE is the only control that is always utilized in the workplace. While the other controls can either be combined or used exclusively, PPE is always used with any of the other controls. While selection of PPE will be determined by the level of hazard exposure, most employers require a minimum of ANSI-spec hard-hat, safety glasses, gloves and safety boots/shoes for any task undertaken at their workplace. PPE is considered by many Safety professionals to be the last step in any risk assessment. The logic being, if you’ve done a proper assessment and utilized the hierarchy of controls effectively, then theoretically, PPE should not have to be called upon to protect the worker. In simpler terms, if your PPE kept you from getting hurt, it’s possible that you didn’t conduct a thorough risk assessment.

The Human Interface – A Benefit or a Detriment?

While the hierarchy of controls can be a wonderful Safety tool, it only is as effective as the individuals utilizing it. Sounds logical, but let’s start factoring in human elements. Such things as fatigue, distraction, lack of training, rushing (getting in a hurry), poor communication, or lack of/poor supervision (leadership!) among others, can all contribute to less-than-effective hazard control. A workplace can have the best safety processes in place, but if the end-user (the worker) is not mentally engaged in that process, it may be all for naught. So, what to do?

Since we’re now dealing with human interface, we introduce other human factors. Such factors as: empowerment, positive reinforcement, proper communication, personal intervention and coaching/teaching. All these are proactive human factors and are critical when countering the afore-mentioned detrimental factors. The secret to using these proactive factors is simple; use them consistently and without fail. Many in the Safety profession (this author included) believe a fifth step should be formally added to the hierarchy of controls. That would be the personal assessment. While many agree that a last-minute risk assessment such as Take 2, Step Back 5x5 and SPSA are all part of a worker’s daily routine, a personal assessment should consist of additional human factors, not just task-specific concerns. Once again, the only way a worker will arrive at such a mindset will be via effective leadership. A fully-engaged worker will be a safe worker and a safe worker requires Safety Leadership to become fully-engaged.

Founded in 1985, CECON LLC specializes in providing science and engineering consultants and expert witnesses. Consultants in their global network typically have more than 25 years of experience; CECON offers consultants in more than 200 disciplines, including pharmaceutical development and regulatory compliance, chemical processing and safety, oil & gas, biotechnology, medical devices, nanotechnology, and polymers and coatings.

For details, visit www.cecon.com or call 302-994-8000.

6 Tips for Controlling Costs When Engaging a Consultant or Expert Witness

2014-07-01T10:00:00.000-04:00

The right expert witnesses can be a key component to helping an attorney win a case. A great deal of attention is paid to finding and contracting with a good expert. While hourly rates may seem high and a large number of hours may be needed for an expert to review the facts of a case and provide a meaningful written opinion, there are ways you can manage the engagement of an expert to keep costs at a minimum.

1. Don’t give your expert more documents to read than necessary – this can drive up charges if the consultant has to spend time reading unnecessary documents

2. Don’t lead expert opinion. While you may have a case strategy, leading or influencing the report can place the expert in an ethical dilemma if he disagrees with your conclusions, require additional research to support, and add to time spent on the case. If you have selected the right expert, allow them to present their professional opinion to you without a requested outcome.

Presenting your case strategy when interviewing a potential expert can let you know if the expert is likely to be on your side, without influencing him. If the expert feels as if his/her opinion has been influenced, he/she may be required to disclose this in court, which may hurt your case.

3. Be easy to contact. This will eliminate delays while the expert is waiting to have questions answered and time charges for multiple contacts.

4. Pay your bill on time. This keeps the consultant focused on the job rather than on following up on payment.

5. Make sure the scope of the project or case is clearly defined. Being on the same page from the start of the project will help insure that your expert or consultant is working on the tasks most important to your case or project.

6. Communicate frequentlyto insure the project is on track and that key deadlines and trial dates are on everyone’s calendar.

For more hands on tips on managing expert witnesses, see our three part series “Guidelines for Your Expert Witness” and other Expert Witness Management Tips on this blog. This series is also available as a Whitepaper; call our offices or email us at info@cecon.com to request a copy.

Founded in 1985, The CECON Group specializes in providing science and engineering consultants and expert witnesses. Consultants in their global network typically have more than 25 years of experience; CECON offers consultants in more than 200 disciplines, including pharmaceutical development and regulatory compliance, chemical processing and safety, biotechnology, medical devices, nanotechnology, and polymers and coatings.

For details, visit www.cecon.com or call 888-263-8000.

Case Study: A New Design for a Water-Cooled Furnace Brings to Life the Concept of “Conservative Innovation”

2014-06-17T08:45:00.000-04:00

When a CECON consultant specializing in chemical and process engineering presented his idea for a new design for a water-cooled furnace to the expert designers he worked with they said one word: IMPOSSIBLE. But employing his concept of “conservative innovationdesign,” he persisted and built a furnace that not only operated successfully, it became far more practical to maintain and repair than the traditional design.

Over the course of five years, I have built and operated a total of seven rotary induction water cooled furnaces—giant furnaces capable of processing hundreds of tons of ore per hour—in two different factories.

When No. 6 was running, my electrician, who I had been working with since No. 1, came into my office and declared: “We must get rid of this water cooling nuisance. You must make an air-cooled coil!” He had a point. Water leakages and sometimes blocked water passages, created safety risks, demanded problematic repairs and consequently caused lengthy down time of the furnaces.

I immediately responded: “Our furnaces are not the first in the world. If this were possible, the Chinese experts who supplied the equipment would have done it long ago. Forget about it! We have enough on our hands.”

He was disappointed, but he understood my point.

But that evening I found myself considering the possibilities. I started writing notes and making sketches. I assumed that if this was really impossible, my engineering calculations would run into a dead end, or some expert will convince me to let go of the idea.

My criteria were that I need the new design to be suitable for conversion of the existing furnaces without major modifications including the need to modify the power supply and control mode. Getting rid of the cooling water nuisance was tempting but not enough to justify a major design revolution, especially considering that we already 6 furnaces running.

It took some calculations and consulting with experts of heat exchange and electrical bus bar designers to come up with an alternative design of an air-cooled coil that would have the same Ohmic resistance as the original despite of the higher working temperature. The copper weight was 2.5 times the original. More expensive but still not prohibitive. I now knew that I had a suitable design.

We knew the maximum current in the coils so we could calculate the power needed to overcome the Ohmic resistance of the coils. We then measured the cooling water flow rate and temperature difference and thus verified that we know the heat load to be removed by the surrounding air. With this in hand, and using some heat exchange coefficients found in literature, we could calculate the surface temperature of any suggested copper profile to be used for the construction of the new AIR-COOLED INDUCTION COIL.

Knowing the service temperature of the Copper we could now find the new specific resistance of the Copper and calculate the required cross section in order that the total coil resistance will be the same as the original. The copper weight was 2.5 times the original. More expensive but still not prohibitive. I now compared my results to engineering tables which I received from an electrical engineer showing service conditions and loads for bare copper cables and bus bars used in electrical panels. The comparison was encouraging. I now knew that I had a suitable design.

What is Conservative Innovative Design?

At this stage I would like to spell out the main characteristics of what I call Conservative Innovative design. The innovative part of this is easy to understand. Once you face a problem, which the existing technology cannot solve satisfactorily, keep your mind open to innovative ideas even if, at first glance they look unsuitable. Do not be afraid of innovation. Have the guts to try new things.

How do you apply innovation in a conservative way? We must remember that we are within an operating facility where a lot of money was invested and time is highly valued. We must respect the “old” technology even if we are critical of it, as this is actually what we have and what is paying the bills and providing pay checks.

We must not be too adventurous or too arrogant. We must consult with many experts, listen to many opinions, especially those which reject our ideas and predict failure. We must be critical to prove to ourselves that the rejecting opinions are wrong–or maybe they are right or partially right and maybe we can learn something and improve. This requires patience and hesitation. A thinking process that does not go through the hesitation stage had simply not been examined deeply enough. Never assume that things will go right. Prove it to yourself!

Conservative Innovative Design in Execution

Sketching the new design, I uncovered additional bonuses. I started with a coil made of a flat copper bar, on which I could do bolted connections, avoiding copper welding—the culprit for many leaks. It took a few iterations to come up with a design where the coil, its support and the “decorative safety cover were all one split-able unit. Dismantling such a coil from the furnace should not even need to stop the furnace. Just bridge the electrical connection over the coil, unbolt the two halves, and split it open. All other elements stay in place. The lower tire stays in place. No cooling water issues. The assembly of a replacement coil would also be very simple. The safety panel which now became part of the coil support did not bother any more. It did not impose inconvenience anymore.

Stopping and cooling the furnace would now only be required when a substantial repair to the thermal insulation was needed. However, such a shutdown would require only 1.5 days versus the standard 6+ days for the water cooled furnace. In this respect, this design became A REVOLUTION.

The problem of rust chips falling onto the copper was also reduced as the short circuits would now not result in water leaks. A short study indicated that we could apply a certain metallic coating onto the outside of the furnace tube that will prevent severe rusting even when the red hot surface is exposed to atmospheric air as a result of a faulty cladding of the thermal insulation.

Pitching to the experts

I was now convinced that the new design was superior to the original. I knew that electrically, the new coils had exactly the same features as the former. The dimensions were similar so the magnetic fields were expected to be the same, the resistance was identical so the power supply regulation would not have to be changed and the operators should not feel any difference, the need for emergency cooling water supply was removed so quite a few control alarms were cancelled. This was the conservative part of the innovation.

A meeting was set up with the Chinese experts whom I knew well and have been working with them for 5 years on 6 furnaces. I presented the subject, first explaining why I wanted the cooling water system replaced by air-cooling. There was a unanimous response: “IMPOSSIBLE!”

The discussion went on for many hours. Chinese people are very polite to a customer. But in the evening they still claimed I should forget about it. After the meeting, my interpreter received a phone call. An electrical engineer, a junior member of the Chinese expert team, asked for a meeting. At the meeting, she asked not to be quoted, and said: “Unofficially, I could find no mistake in your presentation. It will cost you some money and you face the risk of the innovator but it should work.”

Putting the design to work

Now I had to convince management. They approved my suggestion to install 5 such elements on the lower zone of furnace No. 6 and hold the production of the coils for No. 7. The coil producer was set to produce these 5 coils working 3 shifts a day.

Installation went on immediately and the furnace was re-started with 2 water cooled zones and the lower zone, which is always at highest power load, AIR COOLED. The operators did not notice any difference. We studied all parameters carefully and everything was fine.

My electrician reminded me whose idea it was in the very beginning.

Furnace No. 7 cost $100,000 USD more than No. 6. It was air-cooled, without any cooling water piping and no emergency cooling water supply and alarms. It operated as usual. No special excitement. Nothing to write home about. EXACTLY the result we wanted.

Technical background

Giant rotary furnaces are known all over the world as the main equipment in Portland cement factories. A special and different family of the rotary furnaces are the relatively small and short units used for roasting of small quantities of minerals.

This article refers to roasters used to convert Molybdene Sulphide (also called Moly Concentrate – MoS2 ) into Molybdene Trioxyde (MoO3). This process results in emission of Sulphur Dioxide gas. We intend to make Sulphuric Acid out of it, the concentration of the SO2 in the flue gas must be kept high. This can only be achieved by avoiding heating by fire and also by using enriched air ( ~ 90% Oxygen ) instead of atmospheric air. How do we heat such a furnace without a fire? We need indirect heating so here comes in the design of Electrical Induction Heated Rotary Furnace. It does not use direct heating by fire nor external heating by radiative elements.

Description of the Electrical Induction Rotary Roaster

Electrical inductors are very common in the metallurgic industry. They usually consist of a Copper coil surrounding a tube, where AC electrical current in the coil induces a varying magnetic field that in turn induces stray electrical currents in the furnace body thus heating it. This design avoids the traditional heating elements with the associated ceramic insulation and radiative high temperatures, by using the furnace body itself as the heating element.

A heavy duty thick wall special Carbon Steel rotary tube serves as the furnace body. The tube is thermally insulated by high performance ceramic insulating material externally protected by glass fabric. The thickness of the insulation is ~ 25 mm. It is intended to enclose the hot furnace tube, prevent heat loss, protect the environment and prevent atmospheric Oxygen access to the hot iron tube. It must however be totally non-magnetic and therefore, its cladding cannot be made of any metallic plate.

The induction coils are located outside of the thermal insulation. A square Copper tube is formed into coils. Usually the Copper tube will be 20X20X2 mm. The coils are built as elements, each consisting of 7-12 rounds, each round spaced ~ 50 mm from the former round. The diameter of the coil is ~ 125 mm larger than the O.D. of the furnace steel tube. Each element is between 400-600 mm long. A furnace may have ~ 16 elements, usually grouped into 3 zones – Upper, Middle and Lower. Within each zone the elements are electrically connected in series. Each element is cooled by cooling water flowing inside the square copper tube.

The electrical system is designed to heat each zone separately. It is a sophisticated electrical system, converting the 3-phase power into single phase by the use of chokes and capacitors. For temperatures of the Carbon steel body up to 600-750 degC a frequency of 50-60 Hz is sufficient. Higher temperatures require higher frequencies because of the specific magnetic properties of the steel changing at high temperatures. The 50-60 HZ system is very simple which gives it a big advantage.

The process:

Roasting of Molybdene Concentrate is performed around 600 degC. The reaction is exothermic. Therefore, at start-up, full power is applied all along the furnace to heat it to the process temperature. The heavy furnace requires some 24 hours to heat up. Once hot, raw material is fed into the furnace. At the upper side the material is gradually heated while losing its volatiles. At approximately 30% of its way down the material reaches 400 degC and starts burning. Sulphur Dioxide (SO2 ) is emitted. While burning takes place the material produces heat and does not need additional heat supply. The main reaction is completed in the middle section of the furnace. At the lower section additional heat must be continuously supplied as the very small burning rate of the remaining Sulphur cannot provide the needed heat. For these reasons, the furnace heating is divided into zones which are separately regulated. The ability to do this enables considerable power saving by utilizing the exothermic reaction heat to serve as the main heat source for the process. Variations in the chemical composition of the feed material and repeated roasting of off-spec product do however require that the furnace will be properly equipped for full scale heating.

During normal operation the temperature profile is as follows :

- Inside the furnace : ~600 degC.

- The furnace steel body under the insulation : ~ 580-650 degC.

- Outside the thermal insulation : 40-50 degC.

- The Copper coil : Actually same as the cooling water i.e. 20-25 degC.

Problems and corrosion.

Internal corrosion is unavoidable with this type of furnace. However, sticking of material to the furnace surface greatly reduces this effect. Typically, a furnace tube may need replacement after continuous running of 1.5-2 years. However, service times as short as 6 months have also been recorded.

External corrosion should be prevented by the thermal insulation which practically prevents access of Oxygen to the hot iron surface. Faulty thermal insulation may be a contributing factor to considerable external rusting resulting in short furnace tube lifetime.

The cooling of the furnace takes a few hours. Burning inside the furnace continues even when the feeding is stopped. In case of power failure, emergency power is provided for furnace rotation and running of the I.D. fan. Operation staff do not like to interfere with the operation of a stable running furnace so they try not to stop feeding. It is therefore required to provide cooling water to the furnace even at times of power failures. Such a design requirement further complicates the system.

- Any blockage of the water flow through an induction coil is problematic.

- Any water leakage from an induction coil is a safety hazard.

- If the thermal insulation is damaged heavy rust pieces fall off the furnace shell onto the internal side of the induction coils. These cause short circuits which, in turn, might perforate the Copper tube causing water leakage.

- The induction coils are hidden behind safety panels also called decorative panels. Any maintenance work on the furnace requires temporary removal of these panels. Once removed, and especially if maintenance becomes frequent, they tend not to come back – causing further safety issues.

Maintenance and management

The furnace is a heavy piece of equipment. If an induction coil has to be repaired or replaced or if the thermal insulation requires attention, the furnace must be cooled down and stopped. Now some coils must be removed. This requires temporary support of the lower side of the tube, removing the low end tire and pair of rollers, dismantling of the discharge hood and associated equipment, disconnecting the coils from electricity and cooling water, dragging the coils out until the problematic area is reached, maintaining whatever needs to be done and then re-installing everything and re-heating of the furnace. This means a minimum shutdown period of 6 days before feeding could resume.

When such preventive maintenance is required, it is typically happening when production is urgently required and customers are yearning for product. The management will not approve a 6 day shutdown. Therefore, the problematic coil is bridged electrically, cooling water flow to the damaged coil is stopped and the furnace continues to run with less one coil. The problem which was thus ignored does not go away. It causes more damage until there is no more an option to delay.

The air-cooled split-able induction heating coil design changed our plant’s life.

For details, visit www.cecon.com or call 888-263-8000.

The Best Way to Source Consultants/ Legal Expert Witnesses: Social Media or Placement Firm?

2014-06-03T09:00:00.000-04:00

5 Advantages of (and 1 Misconception about)
Using a Consultant Placement Firm over Searching Social Media to Hire a Consultant

With everyone on Linked In and websites so easy to build, it is easier than ever to search for a client or expert on the internet and skip the “middleman” or expert placement firm when hiring a consultant. But should you? Is it really cheaper?

What are the advantages to using an expert placement firm?

1. Vetting. Did the expert whose profile looks so appealing on social media really attend that school? Does he/she really have those skills? A placement firm can vet their experts.

2. Additional experts are available if needed. If you need multiple experts or additional experts in a complementary field, a placement firm can be “one stop shopping.” Your “rep” will already know the details of your project and the expertise you already have, so you don’t need to start over multiple times to engage additional help. You will also just get one invoice, which streamlines paperwork for you.

3. Filtering: Having so many choices of experts can be confusing. A placement firm with experience in a specific practice area is able to help you discern which of a long list of experts is the one who meets your needs. Experts may use a variety of terms in their resumes or websites, whose relevance may be difficult to interpret for someone not in that field. A placement firm can send you a filtered list of candidates.

4. Expertise discernement: What type of expertise is actually needed for your job? It may be different than you think.

In one of CECON’s successful expert placements, a plaintiff’s attorney sought a pharmaceutical consultant with a specific skill set from our expert database. After discussing the case with the client and getting more details, the CECON Project Manager suggested that an expert with a slightly different background would be more appropriate. An expert on regulatory issues and innovative/generic drug labeling was engaged, per CECON’s suggestion. The outcome was a judgment was for the plaintiffs, with a $500 Million Punitive Award.

5. Scope definition. A placement firm whose client service reps have expert experience themselves can often help define and narrow the scope of your job.

For example, CECON Project Managers have helped clients define technical specifications for engineering projects, then sourced the necessary consulting team to complete the projects. If you are uncertain about the full scope and hidden tasks involved with a project, an experienced technical project manager can help you.

And, the one misconception: that fees will be higher. This is not always the case. Fees may be comparable to hiring an expert directly when sourcing a consultant through a placement firm. Because placement firms provide a higher volume of work to a consultant than one client will, they may get a lower rate, which compensates for the placement fee. Placement firms usually understand market pricing and will work to make the net end fee to the user competitive.

So don’t rule out using a placement firm because you think the fee may be higher. The services provided will also save you time in searching, another cost savings.

For details, visit www.cecon.com or call 888-263-8000.

Research News: What’s on the Horizon for the Controversial Medical Stent?

2014-05-19T15:50:00.000-04:00

About 500,000 angioplasties are performed in the United States every year. Dr. Stanley Tocker, a CECON Group Vice President and consultant in this controversial subject area, reports on important happenings in the research of stents.

Medical stents, small expandable mesh tubes used to open narrowed vascular sites or support weakened vessels, have been in the news in the face of multiple lawsuits and two leading medical societies publishing a report calling stents “one of the five most overused procedures in medicine.” The report called into question elective procedures versus emergency situations using stents for patients having heart attacks—where the life-saving benefit is clear.

Angioplasty typically costs around $30,000, and in rare circumstances it can lead to tears in blood vessel walls, bleeding and the formation of blood clots.

All aspects of the stent design, surgical techniques for their use, anti-plaque coatings, coating methodology and materials of construction have been studied. One aspect of stents where some fascinating research is currently taking place is in the material choice.

Most stents are made of stainless steel mesh coated with drug eluting coatings containing drugs that resist plaque formation at the stent site (restinosis). Other than stainless steel, decomposable metals are being tested for the base platform such as magnesium, iron, zinc and tailored metal alloys. The idea is to have the stent physically break down over time, leave the patient and not act as a possible site for reclogging (restenosis) as might be expected for a foreign body in the vascular system.

Chemists are also currently studying polymeric materials for stents that dissipate over a predetermined time frame. Initially, this work has involved polymers based on polylactic acid, used in dissolvable sutures, but it has branched out to other polymers. Such systems can have minimal systemic toxicity because the breakdown products can be similar to those already present in vivo. For example, lactic acid copolymers such as those having glycolic acid units are being studied as well other non-toxic proprietary systems. These “dissolvable” systems also have been accompanied by anti-plaque drugs used within or as coatings.

The goal in these non-stainless steel stents is to maintain the proper strength to survive the surgery , show favorable ductility, dissolution rate and anti plaque character. Considering that these are critical interrelated factors, this is extremely difficult but important research.

Other questions arise such as if everything works well, with dissolvable or biodeecomposible stents, will the application site “bloom” again and become restricted. After all, the on-site plaque is being compressed by the stent, and not being removed. Of course the patients’ individual genetics, age, diet and other human factors also add to the technical uncertainties and difficulties.

A dissolvable stent is already used in Europe. Depending on the results of current research, it could be approved here in a few years. Will dissolvable or biodeecomposible stents totally replace metal stents? Probably not. But it is potentially a breakthrough innovation in a well-tested therapeutic area.

Dr. Tocker consults in this subject area and is a vice president of the CECON Group. Since 1985, The CECON Group has been placing experts in over 200 scientific disciplines. CECON Consultants include medical device experts, pharmaceutical consultants, clinical trials experts, biotechnology experts, and chemistry experts.

Questions to Ask when Hiring an Expert

2014-05-01T10:24:00.000-04:00

When hiring an expert for a consulting project or expert witness testimony in a legal case, it is important to ask the right questions, in the right order, to obtain relevant information to make the best choice.

We asked CECON Vice President and placement specialist Barry Bowen, as well as one of our long-time consultants, a former FDA Science Branch Manager, what they believe the most important questions are to ask potential candidates:

1. Do you have any potential conflicts of interest with any of the parties, such as previous employers? This could include cases you have been involved with, etc.

2. After describing the case: Can you handle this case?

3. Are you available to assist during the required timeframe?

4. What is your experience with the subject matter? This should include discussions of relevant and related background in the subject matter, such as chemistry, clinical studies, device production, packaging, CMO, CRO, quality, regulatory compliance, etc.

5. Do you have a tendency to support client technical views for legal cases? Or are you able to be objective and unbiased?

6. What is your previous experience as an expert witness? Describe your activities surrounding consulting, reporting, deposition, and trial, including appearing on camera.

The answers to these questions will help the hiring manager select the very best expert consultant for the project.

Founded in 1985, The CECON Group specializes in providing science and engineering consultants and expert witnesses. Consultants in our global network typically have more than 25 years of experience in more than 200 disciplines, including pharmaceutical development and regulatory compliance, chemical processing and safety, biotechnology, medical devices, nanotechnology, and polymers and coatings.

For details, visit www.cecon.com or call 888-263-8000.

How One Pharmaceutical Manufacturer Cut Costs while Enhancing Quality, Simplifying Processes and Streamlining Inventories

2014-04-16T09:24:00.000-04:00

In part two of our series on cost control strategies for pharmaceuticals, CECON consultant 1569, specializing in the formulation, manufacturing, packaging, and dosage development of pharmaceuticals, walks us through a personal experience where he was able to lead a pharmaceutical company to realize significant cost savings.

COST CONTROL STRATEGIES IN PHARMACEUTICALS: PART 2

It has been my experience that reticence to change is one of the primary reasons that pharmaceutical companies do not actively pursue cost savings as a means of improving their profitability. It is presumed that little or nothing can be changed, so why bother looking? Other common deterrents to pursuing cost controls:

1. “We have a Purchasing department that is responsible for obtaining the best pricing on all goods and services.”

2. “R&D and Operations, and Facilities know what they want, so who are we (Purchasing) to question their judgment?”

3. “Cost control is not really a viable means of positively impacting the bottom line over the long haul.”

For pharmaceutical manufacturers, it is true that approved raw materials and components, validated processes and methods, and qualified equipment and facilities cannot be changed without significant cost and effort. Yet it is frequently (and mistakenly) assumed that these constitute all of a company’s expenses or that they cannot be modified in some way that can result in significant savings. Let me share an experience to demonstrate the fallacy that little can be changed in a regulated industry that might positively impact a company’s profitability.

A few years ago, I was retained to assess a stem cell manufacturer’s warehousing operations to see what steps could be taken to consolidate and manage their on-hand inventories to accommodate relocation to a new facility. The new facility’s warehouse was only 3,000 ft²—about one tenth the size of the current warehouse—a challenging proposition to support expanded operations.

The first order of business was to evaluate all of the items inventoried in the warehouse and to understand why they were maintained at their current levels. Surprisingly, the company routinely kept on-hand unique inventory items. To name just a few:

1. 15-20 pallets of sterile, disposable coveralls, in 8 unique sizes (Small to 5XL). These consisted of cases of 25 coveralls per case. Provided with Certificates of Conformance.

2. Several pallets of 3% hydrogen peroxide, USP. These were cases of 16 ounce bottles. Provided with Certificates of Analysis.

3. Several pallets of 70% isopropyl alcohol, USP. These were cases of 1 litre (=33.8 ounce) bottles. Provided with Certificates of Analysis.

4. Several pallets of dry ice delivered on a once/week basis.

The R&D group and Operations provided Purchasing with specifications and consumption rates on each of these materials and Purchasing took this information and negotiated supplier contracts to obtain the supplies at volume discounts.

In my assessment of on-hand inventories, I was not concerned about the suitability of these items for their intended use or their estimated rates of usage; but I was very concerned with minimum inventory levels, turn rates, expiry dating, etc. This exercise led me to ask: Are there better supply configurations for each of these materials that would require less space? I was surprised to learn:

1. The average cost of one sterile, disposable coverall was approximately $20.00. Personnel routinely wore two sets of coveralls per day.

2. The cost of a case of six (6) x 16 ounce bottles of 3% hydrogen peroxide, USP was about $240.00 (three (3) x 32 ounce bottles of 3% hydrogen peroxide, USP at Target has a total cost of $2.67). That was one expensive Certificate of Analysis!

3. The cost of a 1 liter (=33.8 ounce) bottle of 70% isopropyl alcohol, USP was about $90.00 (a 32 ounce bottle of 70% isopropyl alcohol at Target is $1.97).

4. The company ordered over 5,000 lbs of dry ice pellets / week for storage, pack-out and shipping of their products. The reason they needed so much was because over 50% of it evaporated prior to its use.

Based upon this preliminary analysis, it became obvious to me that in addition to “right sizing” the company’s on-hand inventory for the new site, there were real opportunities for significant cost savings too. In assessing other supply configurations, it was learned that:

1. With respect to sterile gowning, a local supplier of sterile surgical gowning was contacted and could provide two sets of washable, re-usable sterile gowns on a daily-basis at a cost of about $10.00 / per operator. This was a savings of almost 75%. The vendor’s quality systems were audited and found to be compliant and the vendor provided a certificate of cleanliness and sterility for all of its gowns.

2. The supplier of hydrogen peroxide could provide cases of 4 x 1 gallon bottles of 3% hydrogen peroxide, USP (with a Certificate of Analysis) for about $600 / case. The cost for this same quantity (= 512 ounces total) of hydrogen peroxide provided in cases of 6 x 16 ounce bottles per case was $1,280. A savings of $680per 4 x 1 gallon case configuration.

3. The supplier could provide larger quantities of 70% Isopropyl alcohol, USP. A 4 liter bottle was available at about $200 (a savings of $160 vs. 4 x 1 liter bottles), or a 20 liter bottle at about $550 / bottle (a savings of $1,250 vs. 20 x 1 liter bottles), or a 200 liter drum at $2,500 (a savings of $15,500 vs. 200 x 1 liter bottles).

4. As a large consumer of dry ice, the company investigated installing a dry ice on-demand manufacturing system within its new facility. A calculated Return on Investment of less than two years, made this an attractive undertaking.

These and other similar cost savings valued at a total of approximately $700,000 per year were identified during transfer of the company’s warehousing operations into the new facility. Although finding savings was not the primary objective of the assignment, it turned out to be an important benefit. The company’s Chief Financial Officer was ecstatic as these savings went right to the bottom line. While I was not aware of the company’s profit margin, I estimated it was between 20 and 30%. If true, these savings would equate to an increase in sales of $2.33 to $3.5 million dollars per year, each and every year.

Most noteworthy was the fact that in not one instance was it necessary to change a quality specification, re-validate a process or method, or re-qualify a piece of processing equipment. On the contrary, quality was enhanced, processes were simplified, and inventories were streamlined and optimized.

While this is but one example of a pharmaceutical company where significant savings were found, this is not the lone instance where I have found similar situations within pharmaceutical companies or other FDA-regulated organizations. It has been my experience that NOT finding comparable opportunities is more the exception than the rule. Yet these savings often go unrecognized.

Since 1985, The CECON Group has been placing experts in over 200 scientific disciplines. CECON consultants include pharmaceutical consultants, clinical trials experts, and chemistry experts.

Eight Agricultural Technology Solutions to World Hunger

2014-04-10T08:42:00.000-04:00

The UN estimates that there are 86 food deficit nations, 35 nations currently in a food crisis, and 26 water deficient countries. About 39% of our world’s population is not served by any electric grid and 25% are without basic emergency power. Christianity Today reported 25,000 people were estimated to starve to death daily in a November 2008 article on world hunger.

One root cause, according to CECON Consultant # 1959, a power plant and infrastructure development expert, is that the agriculture that once produced food for direct human consumption has been industrialized and monopolized globally to now produce animal feed, luxury export crops, and global investment commodities out of both reach and benefit to the poor consumer and the small organic farmer alike. Even record yields don’t feed those who can’t afford their price. And the UN reports 41.5% of the world’s people have $2/day or less in spendable income, who are then squeezed out of the market to buy a subsistence plot of land for their survival.

CECON Consultant # 1959 is currently working on technologies in low-cost systems for greenhouse farming and community electric power plants. He proposes eight solutions for dealing with food and energy crises.

1. Build integrated electric power and greenhouse farming systems for serving communities and their surrounding small land holders, a specialty of CECON Consultant # 1959.

2. Construct single community electric power plants based on the site’s capabilities, free and waste fuels, and the project objectives and budget.

3. Establish community-supported agriculture (CSA) in which the people of a community or village pay farmers (usually organic growers using native seed) in advance or by contract for food they pick up from them weekly during the entire growing season.

4. Enable the community or village to purchase local land for a greenhouse farm with additional plots if desired for lease or rental of equal shares to local consumers and growers.

5. Get prospective local small growers together to jointly purchase an agricultural tract, splitting its ownership at closing and possibly retaining equal shares ownership on some common ground for a greenhouse farm.

6. Pressure politicians to stop any cash subsidies to all farms over 20 acres in size, and focus on subsidizing say a 10-acre plot/family for down-payments and/or producing strategic crops for local direct human consumption. Class action law suits might speed up this particular solution as well as others.

7. Pass a family homesteading law to distribute a percentage (say 25%) of all federal and state owned conservation lands (such as Forest Service & BLM land in the US) to be completed in say a 2 year time maximum.

8. Require mandatory redistribution of all corporate farm holdings of 100 acres or larger in 10-acre parcels/family within 1 year. Similarly, Franklin D. Roosevelt required that insurance companies dispose of their acquired agricultural lands quickly in the period just following the great depression of the 1930s.

Experts report that producing the world’s human food requirements will use an amazingly small amount of land if greenhouse farming methods like theirs are applied. Based on their one-acre planned food & energy demonstration model, a 9,486 square mile area irrigated in greenhouse farming under moderately intensive organic farm management will provide adequate fish, fruit, & vegetable protein and nutrition for 6.5 billion people. That area would occupy a square plot 97.4 miles on a side, being 16.86% of the state of Iowa’s size, or 1.4% of the United State’s cropland area of 420 million acres. This area would equal seven global square plots measuring 36.81 miles on a side.

Consultant # 1959 also says that the free fuels of hydroelectric power, solar thermal, and waste utilization can provide the world’s grid-less areas with very affordable electric power without the requiring high tech solutions and equipment. 2,366.4 square miles of land (a square 48.65 miles on a side) could produce 3.029 billion gallons of ethanol transportation fuel per year for 302.9 billion transportation miles using a modern steam car version of the Stanley Steamer automobile (1897-1924). Allard Research & Development is working on a 100 gal/hour community ethanol plant that could pay for itself in less than two years at a capital investment of $150,000 (US).

The challenge is to implement these solutions and safeguards to our freedoms from underneath the special interest alliances already in place. Dr. Vallianatos, in his book This Land is Their Land, reports these hidden self-serving corrupt alliances of land grant agricultural universities, federal governmental agencies, and their big corporate (sometimes multinational) supporters. If the present trend continues unchecked, it is possible that two dozen companies could control most of the planet’s food and energy resources very soon.

Some individuals are undoubtedly already thinking about how to legally implement technology and equipment exchanges discreetly to secure their families and communities or villages.

Note: The opinions contained in this article are those of the author,

CECON Consultant # 1959, and do not reflect an official position of The CECON Group.

The ingenuity, hands-on experience, and technical expertise of its consultants is what keeps CECON thriving. Since 1985, The CECON Group has been placing experts in over 200 scientific disciplines. CECON consultants include Agricultural technology consultants, energy experts, bio-technology consultants, food science consultants, and engineering experts.

5 Reasons Pharmaceutical Companies are Missing out on Significant Cost Savings—Cost Control Strategies for Pharma Part 1

2014-04-08T11:00:00.000-04:00

Many pharmaceutical companies look at cost controls as a means of bolstering their bottom line in the face of increasing competition and external pressures to reduce the price of medications. Yet many struggle to identify and implement significantsavings. CECON consultant 1569, specializing in the formulation, manufacturing, packaging, and dosage development of pharmaceuticals, lays out the top five reasons why. Next week, in Part 2 of this series, we’ll provide a personal example of leading a pharma company to significant cost savings.

1. Reluctance to make changes that might create risk

Pharmaceuticals is a highly regulated industry that requires companies to use approved grades of raw materials and components in processes which must be validated and employ qualified equipment systems and facilities. Additionally, raw materials, components, intermediates, and finished products must be analyzed and released using sophisticated, qualified instrumentation and validated methods. It takes years and millions of dollars to conduct the studies necessary to establish these levels of control before a company is authorized to sell a product. Consequently, companies are reluctant to make changes that might risk the quality and commercial availability of their products.

2. Executive management does not appreciate the potential cost savings within their organizations, and as a consequence, has not made cost control a major business objective of the entire organization.

From the board room to the mail room, commitment to a comprehensive cost control program has to be communicated to and embraced by all employees. Management has to make cost control not only a business objective, but also every employee’s personal performance objective. Each employee should have a job performance objective of actively participating in the company’s cost control program. Companies should seriously consider rewarding employees with a portion of the savings they identify and implement.

3. Companies do not have the proper structure in place to identify and implement significant cost savings.

Because of the vast number of regulations governing pharmaceutical products as well as the inherent complexity in these products’ development and production, it is not realistic to assume that one department (let alone one person as is the case in many companies) can effectively evaluate and implement significant cost savings. An effective cost control program must be a team effort and the team must minimally consist of personnel from R&D, Engineering (Process and Facilities), Operations, Quality, Purchasing, and Regulatory Affairs. These individuals should be cross-trained in basic skills such as Current Good Manufacturing Practices (21 CFR Parts 210 & 211), ICH Quality Risk Management, basic accounting principles, and Return On Investment (ROI) principles. Management needs to empower the team in its work and stand-up for the team when it questions and evaluates a company’s “sacred cows” for potential slaughter.

4. Comprehensive data needs to be collected, maintained, and analyzed with respect to a company’s costs.

To perform an effective evaluation of the best opportunities for cost savings and their potential impact; comprehensive data needs to collected, maintained, and analyzed. In many organizations where I see great opportunities for cost savings, I also see poor documentation and accounting practices. Frequently, expenditures are mis-categorized and as a result, the spending habits and patterns of the organization are not truly known.

5. Like quality, cost, needs to be a characteristic designed into a product

Because of regulatory constraints, and the inherent expense in both time and money, to make changes to approved products; cost must be a design consideration in the development of new products. Companies should evaluate the potential benefit to added product features relative to their cost and ultimately the impact to the profitability of the organization.

There’s no question that there are inherent challenges to identify and implement significant cost savings in pharmaceuticals companies. However, these challenges are not insurmountable. Companies that make a commitment to cost control, set-up the cross-functional teams needed to identify, assess, and implement them, and consider cost in the design of their products can realize significant savings. In my next article, I will offer an example of a pharmaceutical company who cut costs while improving quality.

Nanotechnology Innovation Offers Hope that Diabetics can Skip Injections

2014-04-03T13:16:00.000-04:00

Patients diagnosed with Diabetes 1 and advanced cases of Diabetes 2 often have to give themselves painful insulin injections – sometimes as many as several per day. Researchers at UNC-Chapel Hill and NC State have developed a nanotechnology platform that may enable diabetics to have their insulin delivered painlessly via a handheld ultrasound device that would release nanoparticles infused with the essential hormone.

The nanoparticles used in the study are made of poly(lactic-co-glycolic) acid (PLGA). They were coated with alginate and chitosan which have negative and positive charges so that they would form a “nano-network” through which the insulin’s release could be controlled. In studies done on mice, the nanotechnology networks were administered subcutaneously and then activated through focused ultrasound, providing insulin for up to ten days and eliminating the need for days’ worth of injections.

Nanotechnology innovations have been found to be effective in the treatment of a number of difficult diseases and recently received a lot of attention when UCLA’s Jonsson Comprehensive Cancer Center used them in the treatment of pancreatic cancer. In the UCLA application, two different nanotechnology particles were used: one created a path to the cancer while the other followed and delivered a reservoir of chemotherapeutic medication. The treatment was devised by Andre Nel, a UCLA nanomedicine professor and Huan Meng, an adjunct assistant professor.

The Food and Drug Administration, as well as many of their European equivalents, have approved a variety of drug delivery approaches using PLGA. The use of the copolymer is particularly attractive because it degrades so easily. When it breaks down it produces lactic acid and glycolic acid, two monomers that the body is accustomed to processing and which have minimal toxicity. Other studies into the use of nanotechnology are focused on the delivery of vaccines and even for non-invasive imaging techniques.

Since 1985, The CECON Group has been placing experts in over 200 scientific disciplines. CECON Consultants include Nanotechnology Experts, FDA Consultants, Pharmaceutical Consultants, Experts in biotechnologyand medical devices,, and Polymers & Coatings Experts.

Researchers Use Opal Structure to Improve Thin Film Solar Cell Efficiency

2014-03-27T12:37:00.000-04:00

A new approach to solar cell design is raising hopes for lower cost electricity derived from solar energy. Researchers from Purdue University’s School of Electrical and Computer Engineering and Birck Nanotechnology Center have devised a 3-D synthetic crystal that absorbs, retains and utilizes sunlight more effectively than traditional thin-film cells.

Conventional solar cells are made of single crystal silicon wafers, but those made of thin-film silicon cells are 100 times less expensive. Unfortunately, the thin-film cells’ material and structure allows sunlight to enter and then quickly reflected back out of the cell, making them much less efficient. Perdue researchers have found that by introducing synthetic crystals with an “inverse opal structure” into the construction of the thin-film cells, that once sunlight enters the cell it is diffracted and the opal structure traps light for longer periods of time, increasing the probability of converting the solar power to electrical energy.

According to Peter Bermel, an assistant professor participating in the study, the goal of the research was to determine whether introducing the 3-D photonic crystals into crystalline silicon solar cells would make them more efficient while maintaining their lower cost. “The question is, can we make up that lower efficiency by introducing new approaches to light trapping for thin film solar cells? Can we combine low cost and high performance?”

The study showed that the opal structure increases the thin-film cells’ efficiency and absorption of near-infrared light by approximately 10%, and that with more research greater efficiency may be gained.

Though solar cells were originally designed to be made of thick single crystal silicon wafers, the cost was prohibitive for widespread use, so the multicrystalline and thin-film silicon solar cells have gained in popularity. Unfortunately, their efficiency in absorbing near-infrared light is not optimal. According to Bermel, “Light in the near-infrared range is important because there is a lot of solar energy in that wavelength range and also because silicon can convert near infrared light to energy if it can absorb it, but thin films don’t fully absorb it.”

In order to increase the thin film’s ability to absorb light, the researchers used a process known as meniscus-driven self-assembly to create a synthetic opal structure that is made up of hollow spheres of air that are encased in silicon. Much like natural opals, which diffract different wavelengths of light at different angles, the synthetic opal structure bounces the near-infrared light around internally, lengthening the solar cell’s access to the energy from the light.

Since 1985, The CECON Group has been placing experts in over 200 scientific disciplines. CECON Consultants include energy experts, renewable energy consultants, engineering experts, and films and coatings experts.

Yoga Mat Chemical in Bread: Is it really hazardous? CECON Chemist comments on the toxicity of ADA.

2014-03-24T12:04:00.000-04:00

Several weeks ago, concern was raised by environmental groups about a chemical called Azodicarbonamide, (ADA) a chemical foaming agent that is used in some plastics (like yoga mats) being a common additive in commercially prepared bread. ADA added to bread flour shortens the processing time for commercial bakers by making the dough rise more quickly.

We asked Dr. Stanley Tocker, a chemist with The CECON Group, what he thought of the toxicity of this chemical.

Dr. Tocker reported that this chemical has not been widely tested, but he did not see any supported data on toxicity. While there is lots of chatter about the dangers of this chemical, it appears to be safe at the concentrations (40-50 parts per billion) in commercial products.

According to Dr. Tocker, when ADA is cooked, it breaks down, leaving behind miniscule residues of nitrogen, carbon monoxide, ammonia, and carbon dioxide. Such levels of these chemicals have not been found to be harmful to humans.

So, for now, until solid evidence is presented, you don’t need to worry when eating your sandwich rolls in restaurants!

Dr. Stanley Tocker, Executive Vice President of The CECON Group received his Ph.D. in Organic Chemistry from Florida State University. Dr. Tocker has 40 years of experience in organic synthesis, polymers, pesticides, formulations, patent strategy and chemical products liability. He has served as a technical expert witness on many occasions.

Pharma Outsourcing Trends, Part 1: Why is Pharma Outsourcing on the Rise?

2014-03-21T15:08:00.000-04:00

A question we hear at The CECON Group is “Why are pharmaceutical companies increasingly seeing the need to hire outside consultants?”

We approached Dr. Barry Bowen, CECON Vice President and Program Manager, a consultant with more than 35 years of experience in business leadership, human resources, and technical project management. He offered his observations regarding the areas where companies are using outside consultants in the pharmaceutical industry.

Dr. Bowen has noticed the following trend in client needs:

· Temporary quality control management;
· Audit and reporting expertise;
· CRO/CMO selection and compliance/audit functions;
· New molecule research, including literature and lab work;
· Assistance with strategy for new molecule clinical studies for future FDA acceptance;
· FDA compliance of internal software and computer systems.

We asked Dr. Bowen what was driving these trends.

“These trends are partly due to pharma’s evolving business strategy to gain more growth and more profit from existing product portfolios, rather than high emphasis on filling the pipeline with potential winners. This business model may mean purchasing more research, ingredients or products, all of which must be vetted and tracked for quality and compliance. It may mean protecting intellectual property more vigorously or simply paying more attention to efficiencies of established internal systems. Engaging career pharma specialists, consultants, and expert witnesses for relatively short periods of time, can often be faster and better investments than waiting for new employees to mature.”

A long-time CECON pharmaceutical consultant and former FDA Science Branch Director has noticed another trend: Outsourcing of production of pharmaceuticals themselves. He has observed:

“Pharma production outsourcing occurs because it is cheaper than making it in-house. Labor rates are lower and companies avoid capital expenditures on new (brand new or replacement) equipment. However, firms are starting to see that they have a false economy. There are many cases of API (active pharmaceutical ingredient) contamination, and out-of-specification final products occurring. This is because "you get what you pay for." Buy cheap and get cheap. Pharma executives are beginning to realize this.

Firms are finding out that foreign made products can be problematic. FDA directed company recalls of finished products are occurring. FDA 483s and Warning Letters are being issued. The challenge is to select a quality company when outsourcing, which can cost more and take more time.

My recommendation is that if you contract out, do it in the United States. It will cost more, but you can visit facilities and inspect them readily yourself, thereby avoiding problems. I see that happening now, yet slowly; outsourcing continues, but it will be with domestic firms.”

In the March 3, 2014 issue of Chemical and Engineering News, a series of case studies is detailed in the article “From the Lab to the Production Plant.” The article’s author, Michael McCoy, notes that “Often innovation occurs at small entrepreneurial firms. Typically started by visionary men and women, these companies have great ideas and skilled scientists, but they rarely have the resources to make their molecules at large enough scale or with consistent enough manufacturing processes for use in clinical trials.” Production is then outsourced to contract manufacturers.

Have you noticed any additional trends in outsourcing?

Founded in 1985, The CECON Group specializes in providing science and engineering consultants and expert witnesses. Consultants in their global network typically have more than 25 years of experience; CECON offers consultants in more than 200 disciplines, including pharmaceutical development and regulatory compliance, chemical processing and safety, biotechnology, medical devices, nanotechnology, and polymers and coatings.

For details, visit www.cecon.com or call 888-263-8000.

Adhesive Bonding of Sub-miniature Electronic Devices to Dissimilar Materials: A Case Study

2014-03-13T13:27:00.002-04:00

Our CECON Group consultants, leaders in their fields, are always pushing boundaries. In this blog, one of our chemistry consultants , a Coatings, Adhesives, and Laminates Expert, writes about a recent case study.

Could an alternative adhesive be found which would bond two dissimilar materials for a longer service life?

At issue in the 26-week project summarized here were adhesive bonds used to attach sub-miniature electronic microphones to plastic fixtures that allow the assembly to be incorporated into application-specific packaging. Specifically, the microphone cases were made of stainless steel and the mounting fixtures were glass-filled nylon. These devices are used in actual service for many years and are continuously exposed to high humidity and a temperature of ~95 °F. The goal of the project was to identify alternative adhesives that would significantly enhance bond strengths and be less susceptible to humidity. The result would be longer service life in current applications and development of new applications.

Selections of candidate alternative adhesives were based on three basic technical issues:

The bonded assembly comprises one adhesive layer and two interfaces that must be resistance to temperature and humidity.
Application of adhesives during the bonding process would be done manually.
Due to the heat sensitivity of the electronic device itself, thermal curing of an adhesive would be limited to about 150 °F. The two interfaces noted in item #1 are the metal-to-adhesive and the Nylon-to-adhesive interfaces.

During routine quality control testing to measure adhesive bond strengths, bonded assemblies were exposed to elevated temperature and humidity for a pre-determined period. This was followed by mechanical testing to determine the force required to de-bond the assembly. In many applications, the minimum allowable strength is 10 newtons force.

Baseline evaluations of alternative adhesives with potential for enhanced bond strengths were an essential component of this project in its initial phase. Literature reviews and technical discussions with suppliers who specialize in adhesives for joining dissimilar materials and for applications involving severe environments were used to select candidates for the study. Special attention was given to materials used in the very demanding applications found in micro-electronics, medical devices, and dental procedures.

In its first phase, the scope of the project purposefully allowed for “added risk” in making selections of materials for bond strength enhancements that could be implemented in the very near term. The strategy was to evaluate numerous good candidates—knowing that many would be disqualified—so that near-term solutions could be identified.

Advancements in Chemical Processes Translate Across Applications

2014-03-10T15:54:00.000-04:00

One of the key benefits of bringing a consultant on board is that you gain the benefit of an outside perspective that can stretch your own thinking. In this article, one of CECON’s consultants, a chemical engineer specializing in process design, blogs about leveraging advancements in chemical processes across different applications to improve efficiencies and/or lower costs.

Many of today’s chemical processes still use basic operations developed decades ago. But in the past five decades, the understanding and catalysis of chemical processes has improved dramatically. This applies to polymers (plastics) as well as liquid and solid chemicals. In one research study, projected process efficiencies and operating costs were improved dramatically by developing new catalysts.

For example, one of the greatest advances in manufacturing chemical polymers has been a fluidization process for polyolefins such as polyethylene and polypropylene. Pioneered by Union Carbide (now DOW), the process dubbed UNIPOL has taken over 40% of the world’s production in a span of 25 years. Why? Because the process requires only one half of the capital investment and one third of the operating cost of the former high-pressure processes (30,000 psi).

The typical fluidization process employs a solid catalyst which enables a reactant in vapor form to form a final product. In the case of polyolefins, the catalyst is embedded in the surface of the polymer formed and becomes part of the product.

In other fluid bed processes, the catalyst is separated from the product (vapor) and regenerated and recycled to the fluid bed. In all these cases, the reactant is in gaseous form to act as the fluidization medium as well as a reactant. Formaldehyde, a major raw material for resins that bond plywood and other wood products, is made in such a system by a patented process (DuPont).

Can this technology be applied to other products? CECON’s experts can help answer this question.

How a major pollutant was converted to salable products

Until the mid 1990s, paper mills vented methanol-rich streams to the atmosphere. When this was finally recognized as a major industrial pollutant in the U.S. by the EPA, the pulp and paper industry was ordered to severely reduce their methanol emissions.

The industry resorted to combustion in waste heat boilers or biological digestion in waste treatment ponds. The methanol was converted to carbon dioxide, adding to the amount in the atmosphere.

One pulp and paper company explored the option of converting this waste methanol stream into useful chemical products that could be sold on the open market at values higher than the fuel value of the methanol. This was accomplished by designating the research work to a qualified university. A successful pilot plant confirmed the new process as viable.

Similar programs can be achieved for other contaminants given the right chemistry and experience.

Since 1985, The CECON Group has been placing experts in over 200 scientific disciplines. CECON Consultants include pharmaceutical consultants, clinical trials experts, and chemistry experts.

Strides Made in Generation of Kidney Cells from Stem Cells

2014-02-27T14:58:00.000-05:00

One of our consultants in the medical device sector informed us of new developments in kidney cell research.

Researchers from Brigham and Women’s Hospital and the Harvard Stem Cell Institute in Boston have published an article announcing a recent advancement in the ability to generate kidney cells from embryonic stem cells, as well as from adult skin stem cells. The article appeared in the Journal of the American Society of Nephrology, and represents a leap forward in kidney cell research after a long period of relative stasis.

According to Albert Lam, M.D., lead author of the study, his team was able to identify a protein that would differentiate the stem cells into the early cells that eventually turn into kidneys, called the intermediate mesoderm. Additional manipulations led those early cells into further differentiations and the expression of marker SIX2, which heralds kidney cell differentiation.

The specific treatment involved the application of glycogen synthase kinase 3 beta inhibitor CHIR99021, as well as the same treatment followed by introduction of fibroblast growth factor 2 and retinoic acid.

Though Lam is quick to point out that medical science is still many years away from being able to regenerate functional kidneys, once the results of this research can be reliably recreated, it will be very useful in kidney-related research in the laboratory.

According to Lam, headway in kidney regeneration has been running behind that of similar work involving other organs, but there have recently been several studies that have collectively moved the research forward. “It feels like we’ve been behind for a decade and suddenly within a few weeks, four papers come out. This should certainly spur interest and move the field more quickly.”

The other studies that Lam referenced came from a December 2013 study by Melissa Little, PhD, of the University of Queensland in Brisane, Australia, a study published in November 2013 from researchers at the Salk Institute for Biological Studies in San Diego, and a study published in January 2014 by Japanese researchers. He dismissed the idea that any of the studies had approached the growth of functional kidneys. “It’s one thing to make the cells of the developing kidney and another to make three-dimensional structures that can replace diseased kidneys. We may be closer, but we have a long way to go before we get there.”

The experts and consultants at The CECON Group strive to bring you the most current and in-depth information and assist you in moving your projects forward, saving you time and money. CECON has been helping customers find subject matters experts in the fields of science and engineeringsince 1985.

Vitamins: Don’t Take Them for Granted

2014-02-18T12:30:00.000-05:00

Here at The CECON Group, our experts and consultants are constantly updating their skills and expertise. This means that they keep their eye on the news in their fields to learn of the latest developments. One of our Project Managers, Chemistry Expert Boyd Sorenson, commented on the recent controversy concerning vitamin supplements.

Are vitamin supplements necessary?

We don’t think much about vitamins, except that they are important for our health and we should take them. But what are vitamins, why do we need them, and are vitamin supplements necessary?

Vitamins are small organic molecules that are essential for all life, animals, plants, fungi and even bacteria. Vitamins look like small molecule drugs, pharmaceuticals, with chemical structures shown here. Vitamins in fact serve like drugs as biochemical regulators, promoters or antagonists in living organisms. They are particularly important in relation to protein systems and functions in an organism.

What is interesting about vitamins is that they are essential for living processes, but only a small amount of each chemical is necessary to keep an organism healthy. For example, in humans, just a small amount of vitamin C will prevent scurvy and, likewise, a small amount of vitamin D will prevent rickets. But if vitamin C or D is not in a human’s diet, these diseases can appear and can be devastating.

The human organism requires about 20 vitamins to survive. Interestingly, of these 20 vitamins, the body only manufactures vitamins D and K. All the other vitamins must come from the diet, like vitamin B1 (thiamine) from meat or vitamin C from fruit and vegetables. The New York Times published a recent science article about vitamins discussing their evolutional history as related to living organisms. One theme of the story was that early life forms could make their own vitamins but, over time and evolutionary cycles, many organisms lost the capability to make these essential vitamins. This is because the vitamins became so plentiful in the diet and food sources that genes specific to the manufacture of vitamins in the organism’s DNA mutated and became inoperative, and not needed.

The article discussed the pioneering work of Dr. Harold White of the University of Delaware, defining the role of vitamins in living systems and their critical roles in RNA functions and protein synthesis. Dr. White’s early theories have recently been validated by more scientific studies.

The Value of Vitamins Questioned

A recent editorial in Annals of Internal Medicine has the headline “Enough Is Enough: Stop Wasting Money on Vitamin and Mineral Supplements.” The editorial reviews many recent studies of multivitamin supplements trials with collectively more than 400,000 participants. The conclusion is that there is no “clear evidence of a beneficial effect of supplement (vitamins) on all-cause mortality, cardiovascular disease, or cancer.” The article concludes that the average diet in the United States is generally adequate to provide the small amounts of vitamins actually needed, and that U.S. supplement consumption of nearly $28 billion in annual sales (2010) is not supported by scientific study and fact. In fact, in some cases such as vitamin E and beta carotene, high dosage levels can be harmful to humans.

So, even though the value of supplements is being questioned for those with well-balanced diets, it is important to realize how vital vitamins are to health, whether they come from food or a supplement. It is equally important to pay attention to the amount of each vitamin being consumed, via supplements or through food.

How to Hire an Expert

2014-02-05T13:20:00.000-05:00

Selecting the best expert for your case or project can be challenging if you are not an expert in the subject matter yourself. Candidates’ websites and resumes may all look good; how do you know which expert is the most qualified?

Click here for a whitepaper offering strategies for expert selection.

CECON’s project managers are available as a free resource to assist in expert searches. CECON project managersare all technically trained, several with Ph.Ds, and have many years of real-world experience. Their backgrounds will help you discern which candidates’ qualifications are best suited for your case or project.

The CECON Group has been providing free, custom expert searches since 1985.

New Battery Technology: Increase the Useful Life and Storage Capacity of Your Devices

2014-01-28T15:10:00.000-05:00

The CECON Group’s battery experts see a $30 Million investment in high-energy silicon battery production as a good sign that this technology may soon be widely available. Some smartphone makers are already using this technology and electric vehicles and computers are expected to follow suit.

High Energy Silcon Batteries Increase Storage Capacity by 50%

Lithium-ion batteries power today’s portable electronics and electric vehicles, and it has long been known that if these batteries were manufactured using silicon electrodes rather than the graphite that is currently in use, their storage capacity would increase by approximately fifty percent. However, because silicon electrodes expand and contract as the battery is charged and reused, they have broken easily.

According to Yi Cui, founder of Amprius, this problem can be solved by producing silicon nanowires. But the production of these wires required the creation of specially-created manufacturing equipment, making the process cost-prohibitive until now. After spending time developing a different product that could be manufactured in existing factories, the company has announced that it has generated the $30 million in venture capital that it needs to move ahead with the production of the longer-lasting batteries, and they have already begun selling them.

Potential Charging Capacity

Amprius’ CEO, Kang Sun, reports that their first product was a battery that utilized a nanoparticle that had silicon at its core but was protected by carbon, which made it more resilient. Though the product was able to hold its charge longer than those that were already on the market, they do not approach the charge capacity of the silicon nanowire product that they are now producing. Where the core-shell batteries could store 650 watt-hours per liter as compared to the conventional lithium-ion batteries’ capacity of between 400 and 620-watt hours, the new silicon electrode batteries will be able to store 750-watt hours of charge.

Still in question is the number of times that the new batteries will be able to be recharged while retaining enough charging capacity. The core-shell batteries have proven to be able to last through more than 500 recharges while maintaining 80% of its capacity, and Amprius is anticipating that the new silicon electrode battery will be able to be charged anywhere from 700 to 1,000 cycles. This could mean that the average American car driver would get approximately ten years of use out of the battery.

Experts and consultants from The CECON Group are tuned in to the latest news and developments in science and engineering. Finding experts in chemistry, pharmaceutical, engineering, and biotechnology(and many other technical fields) for attorneys, corporate clients, and small businesses is CECON’s specialty.

Pharmaceutical R&D Game Changer: Could Watson Revolutionize Healthcare and Research?

2014-01-17T16:44:00.000-05:00

The CECON Group’s experts and consultants are tuned in to the latest news and developments in their fields. A story that caught the attention of our clinical trial design experts and medical device experts last week was IBM’s unveiling of the IBM Watson Group.

From Quiz Show to Breakthrough

It was the Jeopardy! game show that first drew attention to Watson, the artificial intelligence supercomputer that beat some of the game’s top players in 2011. To achieve these wins, researchers fed thousands of information points into the machine, allowing it to use natural language to search and retrieve relevant information. Though scoring a Jeopardy! championship was an amusing challenge for IBM researchers, their ultimate goal for Watson was far more ambitious, as underscored by the company’s announcement on January 9th.

Said Michael Rhodin, Senior Vice President, IBM Watson Group, "IBM has transformed Watson from a quiz-show winner into a commercial cognitive computing breakthrough that is helping businesses engage customers, healthcare organizations personalize patient care, and entrepreneurs build businesses.”

Big Bucks, Big Bang

IBM plans to invest $1 billion in the Watson Group, including $100 million in venture capital to support an ecosystem of entrepreneurs developing Watson-powered apps. By year-end, the division anticipates having a staff of 2,000 at its new headquarters in New York City’s “Silicon Alley” technology hub.

The Watson Group will focus on research, development, and commercialization of cloud-based cognitive computing services, software, and apps based on the Watson platform. This new class of tools and technologies is capable of analyzing, improving by learning, and discovering answers and insights to complex questions from massive amounts of disparate data.

”These new cognitive computing innovations are designed to augment users’ knowledge, be it the researcher exploring genetic data to create new therapies or a business executive who needs evidence-based insights to make a crucial decision,” said Rhodin.

Dynamic Support for Medical Decisions

In the few years since the Jeopardy! game, IBM has been working hard to harness Watson’s big data power in healthcare and research medicine. One result of this effort is WatsonPaths, a medical app unveiled last November, which IBM developed in collaboration with the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University. WatsonPaths helps physicians and medical students learn how to make more informed and accurate diagnostic decisions, pulling from tens of thousands of reference materials, clinical guidelines, and medical journals in real-time. When a student or physician asks WatsonPaths a question about a hard-to-diagnose patient, Watson pulls from the data to refine diagnoses and recommend treatment options. WatsonPaths provides a map of medical evidence that the physician can drill into to decide if certain chains of evidence are more important, provide additional insights and information, and weigh which paths of inferences lead to the strongest conclusions.

As medical experts and physicians interact with WatsonPaths, the system uses machine-learning to improve and scale the medical data and get “smarter.”

A Game Changer for Pharmaceutical R&D

Medical experts and clinical trial design experts at The CECON Group will be keeping an eye on one of the new Watson services that IBM announced last week. It’s called IBM Watson Discovery Advisor, and it aims to revolutionize how industries such as pharmaceuticals and publishing conduct research.

It takes 8.5 years on average for a pharmaceutical treatment to go from initial research stage into practice, according to the Pharmaceutical Research and Manufacturers of America. IBM Watson Discovery Advisor will help pharmaceutical companies do more with their R&D investments while empowering research teams to accomplish more in far less time. According to an IBM press release, “The Discovery Advisor is designed to reduce the time researchers need to formulate conclusions that can advance their work, from months to days and days to just hours.”

While they don’t yet have a Watson supercomputer, the experts and consultants at The CECON Group are continually updating their knowledge base in their respective fields of pharmaceutical clinical trials, biotechnology, medical devices, regulatory compliance, and information technology—to bring you the most current and in-depth information and help you move your projects forward.

Ear Creation from Living Cells – Scientific Progress Reignites Ethical Questions

2013-12-20T16:43:00.000-05:00

Scientists at Cornell University, led by Associate Professor of Biomedical Engineering Lawrence Bonassar, have created an artificial ear using 3D Printing Technology. Their research goal is to be able to regenerate cartilage anywhere in the human body.

The science is fascinating. A camera takes a 3D image of a patient’s head, then ink containing living cells is used to formulate a custom ear that looks and acts like a natural ear.

The living cells used in the ink can be taken from the patients themselves, which is a longer and more painful process, or, as in this study, cells can be derived from collagen from rat tails combined with cartilage from cows’ ears.

The researchers, however, are looking at “ways to expand populations of human ear cartilage cells in the laboratory so that these cells can be used in the mold, instead of cow cartilage.” Could this create ethical complications, as seen in the HeLa cells used in cancer research?

Henrietta Lacks was an African-American woman who was the unwitting source of cells which were cultured by George Otto Gey to create the first known human immortal cell line for medical research. This is now known as the HeLa cell line. Her family members’ cells were also used in research without their consent and Henriettta’s medical records were published without consent, sparking a debate about the ethics of scientific research using human tissue.

According to the author of “The Immortal Life of Hentrietta Laks”, Rebecca Skloot:”A lot of the ethical questions raised by Henrietta’s story still haven’t been addressed today: Should people have a right to control what’s done with their tissues once they’re removed from their bodies? And who, if anyone, should profit from those tissues? Henrietta’s story is unusual in that her identity was eventually attached to her cells, so we know who she was. But there are human beings behind each of the billions of samples currently stored in tissue banks and research labs around the world. The majority of Americans have tissues on file being used in research somewhere, and most don’t realize it. Those samples come from routine medical procedures, fetal genetic-disease screening, circumcisions, and much more, and they’re very important for science—we rely on them for our most significant medical advances. No one wants that research to stop, but it’s pretty clear that many people want to know when their tissues are being used in research, and when there’s a potential for the results of such research to be used commercially. The story of Henrietta, her family, and the scientists involved put human faces on all of those issues, which can otherwise be pretty abstract.”

Bioethicist Ruth Faden wrote an op-ed piece for The Baltimore Sun several years ago in which she stated: “Happily, today, consent is regularly obtained to take tissue or other body components for research purposes. But Mrs. Lacks' story has brought new focus to many tough bioethical and public policy questions that persist. Chief among these are: What, exactly, should patients be asked to consent to if the fruits of the research are unpredictable? Should they be compensated if, years or decades later, institutions, scientists or drug companies benefit financially? Should each and every subsequent or conceivable use of human tissue require a separate consent from patients or their families? How do we protect patient privacy in such situations?”

As research continues to explode in areas such as the 3D printing of ears, will these ethical issues continue to be debated?

Learn more about this scientific breakthrough in The Cornell Chronicle or in this video.

This article was posted by The CECON Group, a science and engineering consulting firm providing experts in such fields as biomedical consulting, pharmaceutical consulting, and chemistry consulting.

PA Attorneys Now Required to be Tech Savvy

2013-12-16T12:58:00.003-05:00

The Pennsylvania Supreme Court joined other states, such as Massachusetts, and amended its rules of professional conduct effective November 21^st to include requirements that attorneys keep abreast of changes in relevant technology and take reasonable care to prevent inadvertent or unauthorized access to client information.

This change is in alignment with the ABA’s Rule 1.1, which charges attorneys with monitoring “the benefits and risks associated with relevant technology.” Will other states follow in MA and PA’s footsteps and add similar state guidelines?

Some suggestions to help busy attorneys meet this standard:

1. Discuss data security with staff members, experts, and consultants and have a written document security policy. Be sure to include security guidelines for portable devices (smartphones, tablets, thumb drives).

2. Be careful about using devices on public Wi-Fi networks.

3. Delete your Google history or cookies regularly to avoid targeted ads inadvertently appearing on your computer screen that could disclose your case strategy to someone looking over your shoulder.

4. Research the best software to organize and protect your paperless files.

5. Install security software on all your devices and do semi-annual checks to insure you and your staff are adequately protected from viruses and hackers.

6. Subscribe to e-alert services such as Technolawyer or USCERT to receive updates on new developments in technology.

Previous CECON posts have addressed issues in expert management related to technology and confidentiality (Do You Disclose Case Docs to Potential Experts? And ESI Management- Another Criteria for Expert Witness Selection).

A variety of other tips and resources for staying on top of technology can be found at Americanbar.org and Law.com.

The CECON Grouphas been providing technical experts to attorneys since 1985. Full service expert searches by seasoned industry professionals are CECON’s focus.

Researchers Develop Wearable Battery

2013-12-04T14:39:00.000-05:00

Wearable mobile electronic devices are a step closer to becoming a reality following the development of textile-based foldable batteries by a research team from the Korea Advanced Institute of Science and Technology. The batteries are designed to be rechargeable via lightweight solar cells.

The battery utilizes a current collector, binder and separators that incorporate a nickel and polyurethane-coated polyester yarn. The composition allows the battery to be folded several thousand times without losing any of its functionality.

According to the researchers involved in the project, previous attempts at the technology have failed due to the batteries being too inflexible. More durable electrodes made by dipping cloth in nanoparticle solutions have been stronger but have an electrical resistance that is too high to allow them to store adequate amounts of energy.

The research team of Jang Wook Choi, Take-Soo Kim and Jung-Yong Lee, all of the Korea Advanced Institute of Science and Technology, redesigned the electrodes utilizing nickel, which is highly conductive, and using it to coat the fabric. By using polyurethane fabric they were able to eliminate binding problems and allow the battery to maintain its integrity. Anodes and cathodes were made using conventional battery materials.

The product has been tested extensively and was found to be capable of being folded and unfolded ten thousand times. To date it has been utilized in a sweatshirt and a sweatband, but future applications may include other types of clothing, watches and backpacks. The units are sealed so that the fabric can be washed without concern of damaging the battery.

The batteries will be recharged using flexible solar cells that are also integrated into the fabric. Further development plans are to improve the batteries storage capabilities. The researchers anticipate that the new technology can be produced in already-established facilities.

For pictures and more details on this technology, click here.

The CECON Group has 26 battery experts who consult on legal cases and short term projects for businesses. The CECON Group has over 1200 technical experts in over 200 technical specialties in its network.

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