Microtest Labs

ATS Labs, Inc. Announces the Acquisition of MicroTest Labs, Inc.

noreply@blogger.com (Microtest Laboratories) — Mon, 14 Jul 2014 15:59:00 +0000

Eagan, Minn., July 14, 2014 -- Today, ATS Labs, Inc. (ATS), majority owned by Ampersand Capital Partners, announced that it acquired the assets of MicroTest Labs, Inc. (MTL) of Agawam, MA. The acquisition of MTL is the first step in the strategy of ATS to expand its microbiology and chemistry laboratory services platform to support the medical device and biopharmaceutical industries. The combined companies will soon be known as Accuratus Lab Services, a name that personifies the quality and accuracy of testing results and scientific solutions that support the antimicrobial, consumer product, medical device, and biopharmaceutical industries.

“The acquisition of MicroTest by ATS has been a long time in the making and I could not be more pleased about the future of the two companies and how they will combine to create the market leader in providing microbiology and analytical chemistry testing services,” said Dr. Steve Richter, CEO of MTL. Dr. Tom Burnell, Executive Chairman of ATS added, “Like ATS, MicroTest has a strong reputation in the industries it serves, which is supported by long-standing client relationships. Leveraging the strengths of the two companies will only further enhance our ability to continuously exceed our client’s expectations.” It is expected that administrative functions will be consolidated, but the company will continue to operate at its locations in Eagan, MN and Agawam, MA.

About ATS Labs:

ATS Labs is the leading global provider of antimicrobial and biocide testing services; committed to improving public health and generating value for customers. ATS Labs has been an expert partner to the developers, manufacturers, and users of antimicrobial products for over 20 years; providing a comprehensive range of microbiology, virology, and product chemistry services.

For more information on ATS Labs go to www.ATS-Labs.com.

About MicroTest Labs:

MicroTest Labs is a leader in testing services for the medical device, pharmaceutical and biotechnology industries. Founded in 1984, the company’s expertise and flexible processes enhance product safety and security, speed time to market, and minimize supply chain disruption.

For more information on Microtest Labs go to www.MicroTestLabs.com.

About Ampersand Capital Partners:

Ampersand is a middle market private equity firm with a focus on growth equity investments in the Healthcare sector. Over the past two decades, Ampersand has managed $1 billion in private equity partnerships. Ampersand leverages its unique blend of private equity and operating experience to build value and drive superior long-term performance alongside its portfolio company management teams. Ampersand’s portfolio has included more than 20 years of successful investments in the laboratory products and services industry.

Additional information about Ampersand is available at www.AmpersandCapital.com.

Download the official press release.

Fundamentals of Endotoxin Testing for Medical Device Manufacturers are Detailed in New Technical Brief

noreply@blogger.com (Microtest Laboratories) — Mon, 19 May 2014 14:26:00 +0000

AGAWAM, MASS. — The fundamentals of endotoxin testing for medical device manufacturers — from definition to assay acceptance criteria —are detailed in new technical brief available from Microtest Laboratories.

Bacterial endotoxins cause fever, septic shock, and other disease symptoms — and thus attract considerable regulatory scrutiny from such organizations as the U.S. Food & Drug Administration (FDA) and the United States Pharmacopeial Convention. Regulations require that devices that contact circulating blood or cerebrospinal fluid, or are used with intraocular products or in vitro fertilization procedures, are required to be endotoxin-free.

“The Fundamentals of Endotoxin Testing,” available for download at http://microtestlabs.com/endotoxin-testing, is a step-by-step information resource for medical device manufacturers discussing and detailing the:

Definition of endotoxins;
Various tests used for their detection;
Use of depyrogenation and other ways to remove endotoxins;
Types of devices that should be tested;
Preparation and testing of samples;
Options for sampling containers;
Acceptance criteria for each of the assays; and
Sources of official information, reference, and guidance.

“The Fundamentals of Endotoxin Testing” is authored by Steven Richter, Ph.D., said Steven Richter, Ph.D., president and scientific director of Microtest Laboratories — and a former FDA official.

Download the brief from: http://microtestlabs.com/endotoxin-testing.

The paper is one in a series about testing, manufacturing, and regulatory issues of concern for medical device manufacturers from Microtest Laboratories, a leader in testing services and contract manufacturing for medical devices, pharmaceuticals, and biotechnology.

About Microtest Laboratories

Microtest Laboratories is a leader in testing services and contract manufacturing for medical devices, pharmaceuticals, and biotechnology. It was founded in 1984. The company’s expertise and flexible processes enhance product safety and security, speed time to market, and minimize supply chain disruption. Microtest’s unique single-source capability to provide testing and manufacturing solutions allows the firm to support a full pharmaceutical or medical device product release. The company’s facilities in Agawam, Massachusetts, USA include state-of-the-art aseptic manufacturing areas; analytical chemistry, microbiological, and virological laboratories; Class 100 clean rooms; onsite steam and ethylene oxide sterilization, plus depyrogenation capabilities; purified water systems; and voice/data systems. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs on Facebook at http://goo.gl/TndoBg.

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Press contact: Don Goncalves, 1-781-793-9380, dgoncalves@tizinc.com

Download image for publication: http://flic.kr/s/aHsjNR56it

Disinfectant Qualifications in Pharmaceutical Manufacturing Environments is Focus of White Paper

noreply@blogger.com (Microtest Laboratories) — Mon, 12 May 2014 14:14:00 +0000

AGAWAM, MASS. – May 12, 2014 – A white paper outlining the six steps that pharmaceutical and medical device manufacturers must employ to qualify disinfectants used in their environmental cleaning processes is available from Microtest Laboratories. It is available for download from http://microtestlabs.com/6stepspaper-disinfectant-qualification.

“Sterile pharmaceutical and medical device manufacturing environments require an effective cleaning and disinfection program to maintain aseptic conditions and prevent the microbial contamination of the product. The qualification of the chemical disinfectants used in these environments is extremely important, yet it is often overlooked,” stated Deborah Ensign, supervisor, R&D of Microtest Laboratories, in the new white paper, “Six Steps to Qualifying Disinfectants.”

In fact, “disinfectant qualifications require more planning, time, and resources than many companies realize,” she said.

“Any time a new disinfectant is introduced into the cleaning process within the facility, a qualification should be performed. From start to finish, a disinfectant qualification can require from 2 to 12 months.

“The timeline for a disinfectant qualification will depend on a number of variables, including the number of disinfectants and challenge organisms being tested as well as the number of surfaces (for the coupon method) being evaluated,” Ensign noted.

“The bottom line is that no matter whether the disinfectant qualification is performed internally — or by an outside testing laboratory — these six steps must be addressed,” she warned.

Download a free copy of the white paper, “Six Steps to Qualifying Disinfectants” for pharmaceutical manufacturing companies from http://microtestlabs.com/6stepspaper-disinfectant-qualification.

Deborah Ensign is supervisor, R&D Lab, at Microtest Laboratories Inc. She has over 20 years of experience in regulatory microbiology and contract laboratory operations. Ms. Ensign supervises Microtest’s Specialized Microbiology department. She holds a bachelor of arts degree in microbiology and is a nationally registered microbiologist. Ms. Ensign oversees all reusable testing (cleaning, disinfecting, and sterilization) and serves as a resource for USP testing, specifically <51>, <61>, and <62>.

About Microtest Laboratories

Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

The Impact of the Drug Quality and Security Act on Compounding Pharmacies Is the Subject of May 13th Seminar in Boston

noreply@blogger.com (Microtest Laboratories) — Sun, 27 Apr 2014 10:04:00 +0000

AGAWAM, MASS. — April 29, 2014 — A seminar focusing on the impact of HR3204 — the Drug Quality and Security Act — on compound pharmacies and manufacturers is the subject of a seminar set for May 13, 2014 in Dedham, Mass., near Boston.

Meeting the new guidelines will require substantial changes for many compounders. The seminar is designed to explain the stepping stones needed to comply with the new legislation as well as review USP <797> in its current state.

The seminar will provide pharmacies and compounders that do business as compounding manufacturers and outsourcing facilities with the knowledge they need to know about how the new regulatory expectations will affect their businesses.

Seminar topics will include:

· Becoming a compounding manufacturer

· Manufacturing under cGMP requirements

· Meeting current USP <797> requirements

The seminar will be presented by Microtest Laboratories, a leader in testing services for the medical device, pharmaceutical, and biotechnology industries, on Tuesday, May 13, 2014, from 9 a.m. to 3 p.m. at the Endicott House in Dedham, Mass., just outside Boston. Registration is at 8:30 a.m. A continental breakfast, break refreshments, and a luncheon are included.

To register, visit http://www.microtestlabs.com/seminar or contact Julie Adamski 1-800-631-1680, ext. 192, or jadamski@microtestlabs.com. Advance registration is $149.

About Microtest Laboratories

Microtest Laboratories is a leader in testing services for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Laboratories on Facebook at http://facebook.com/MicrotestLaboratories, on LinkedIn at http://goo.gl/H8ZLnM or on Twitter @MicrotestLabs.

Parenteral Drug Association to Discuss Rapid Micro Systems and Tour Microtest Laboratories on May 6th in Agawam, Mass

noreply@blogger.com (Microtest Laboratories) — Sat, 26 Apr 2014 22:22:00 +0000

AGAWAM, MASS. — April 28, 2014 — The New England Chapter of the Parenteral Drug Association (PDA) will feature “Rapid Micro Systems: A New Tool in Navigating the Stormy Seas of Biological Testing” at a May 6 meeting in Agawam, Mass. The meeting also will include a tour of Microtest Laboratories, a leading provider of life science testing services for pharmaceutical and medical device companies.

Keynote speakers at the meeting will include the following:

Dr. Bradford O. Fanger, Ph.D., field applications scientist at Azbil BioVigilant, will discuss “Reducing Manufacturing Risk with Rapid Microbiological Methods.” In his presentation, Dr. Fanger will provide an overview of rapid microbiological systems, the different types available, and their advantages.

James Gebo, senior research and development scientist, Microtest Laboratories, will review “Evaluation and Implementation of Rapid Microbiological Methods.” His presentation will explore the applications for rapid microbiological systems, review the business case for purchasing the technology, and explain ROI reporting.

The dinner meeting will be held at Kaptain Jimmy’s Restaurant and Distillery, 916 Suffield Street, Agawam. The Microtest tour will leave the restaurant at 4 p.m. Both PDA members and non-members are invited to attend.

To register, visit https://store.pda.org/Meetings/Login.aspx?ID=2273.

About the Parenteral Drug Association

The Parenteral Drug Association (PDA) is the leading global provider of science, technology, and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its more than 9,500 members worldwide. The New England Chapter was formed in 1988, and represents PDA members from the six New England states: Massachusetts, New Hampshire, Rhode Island, Vermont, Maine, and Connecticut.

About Microtest Laboratories

Webinar Exploring “What’s the Risk? Fearing the Failure in Environmental Monitoring Systems” is Offered for Life Science Companies

noreply@blogger.com (Microtest Laboratories) — Tue, 11 Mar 2014 13:41:00 +0000

AGAWAM, MASS. — March 11, 2014 — A webinar to help life science companies explore the importance of a well-implemented and understood environmental monitoring program, and its ability to generate valuable data, will be offered on Wednesday, March 26, from 1:30 p.m. to 3:30 p.m. EST. The online event will identify the common mistakes and misconceptions regularly encountered when managers “fear the failure” of environmental excursions.

Environmental monitoring systems demonstrate that a company’s various contamination control strategies are operating properly. Such systems can illustrate whether operations are in a state of control. Variations in the data can indicate a drift which could potentially impact product and patient safety.

But the data generated by environmental monitoring system may become skewed when a culture is created which fears environmental failures or excursions. The webinar, “What’s the Risk? Fearing the Failure in Environmental Monitoring Systems,” will detail how key life science company management can work to avoid such cultures.

Webinar topics — tailored for quality assurance and control, manufacturing, microbiology, and facilities management in pharmaceutical, biotech, and medical device organizations — will include:

The big picture: what systems need to be monitored and why the data is valuable
Risk-based environmental monitoring program implementation
Culture and “buy-in:” how to create a culture of employee acceptance for contamination control programs
Responding to data: how to identify trends in the data and respond with appropriate actions

The webinar will be offered Wednesday, March 26, 1:30 p.m. to 3:30 p.m. EST. Featured speakers include Valerie Montgomery, environmental services manager, and Alison Zulick, environmental services leader, both of Microtest Laboratories, a leading provider of testing services and contract manufacturing for the life science industries.

To register or for more information about the webinar, “What’s the Risk? Fearing the Failure in Environmental Monitoring Systems,” visit http://www.microrite.com/training/environmental-monitoring-systems-fearing-the-failure.

About Microtest Laboratories

Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and compounding pharmacy industries. Based in Agawam, Massachusetts, USA, Microtest leverages its 30 years industry experience to help its clients meet their regulatory requirements. For more information, visit http://www.microtestlabs.com or toll-free 1-800-631-1680.

Fundamentals of Endotoxin Testing for Medical Device Manufacturers are Detailed in New Technical Brief

noreply@blogger.com (Microtest Laboratories) — Tue, 14 Jan 2014 13:27:00 +0000

AGAWAM, MASS. — January 14, 2014 — The fundamentals of endotoxin testing for medical device manufacturers — from definition to assay acceptance criteria —are detailed in new technical brief available from Microtest Laboratories.

Definition of endotoxins;
Various tests used for their detection;
Use of depyrogenation and other ways to remove endotoxins;
Types of devices that should be tested;
Preparation and testing of samples;
Options for sampling containers;
Acceptance criteria for each of the assays; and
Sources of official information, reference, and guidance.

Download the brief from: http://microtestlabs.com/endotoxin-testing.

About Microtest Laboratories

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Microtest Laboratories Offers OECD Fish Embryo Toxicity Testing

noreply@blogger.com (Microtest Laboratories) — Tue, 03 Dec 2013 17:42:00 +0000

AGAWAM, MASS. — December 3, 2013 — Microtest Laboratories, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries, is adding OECD Fish Embryo Toxicity Testing to its portfolio of services.

Pharmaceutical, chemical, and related manufacturing plants are under increased scrutiny for the potential impact of their products or waste water on the environment. Pesticides are a major example. But recently, the European Commission added three pharmaceutical compounds to its pollutant watch list, citing them as potential risk to the safety of surface water.

“Fish Embryo Toxicity (FET) testing has been developed for environmental and hazard classification applications. The test utilizes the embryo of the Zebrafish and exposes it to various compounds to observe potential toxic effects, thus making FET an ideal method to use in monitoring or investigating environmental cases,” said Steven Richter, Ph.D., president and scientific director of Microtest Laboratories — and former FDA official.

The FET test is an approved OECD (Organization for Economic Co-Operative Development) guideline, published in August, 2013.

““Microtest Laboratories is deeply experienced in fish embryo toxicity testing. We are particularly well-suited to undertake FET testing due to the expertise we’ve developed in creating our Zebrafish Embryo Toxicity (ZET) test, which we’ve been providing as a preliminary screening method in the biocompatibility testing of medical devices and polymers.

“Zebrafish embryos are extensively used in drug development studies due to their transparent embryos and fast development times. The Zebrafish is a well-studied and characterized organism, and ideal as an animal testing model,” Richter noted.

For more information about Microtest Laboratories’ FET testing services, visit http://www.microtestlabs.com/zebrafish-embryos-testing. Or, call 1-413-786-1680 or toll-free at 1-800-631-1680.

In addition, a new whitepaper provides an overview of FET testing. Download "Fish Embryo Toxicology Testing: The Better Alternative for Whole-Effluent Testing" from: http://microtestlabs.com/fish-embryo-toxicology-testing.

About Microtest Laboratories

Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free at 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

Current Regulatory Expectations Affecting the Validation of Reusable Medical Devices is Subject of Dec. 4th Seminar in Boston

noreply@blogger.com (Microtest Laboratories) — Tue, 12 Nov 2013 16:49:00 +0000

AGAWAM, MASS. — Nov. 12, 2013 — A half-day seminar focusing on current regulatory expectations in the validation of reusable medical devices is the subject of a seminar set for Dec. 4^th in Waltham, Mass., near Boston.

The validation of reusable medical devices is at the forefront of the FDA’s efforts to ensure patient safety. Requirements for the cleaning, disinfection, and sterilization of reusable devices are constantly changing. The situation challenges manufacturers both in terms of deciding which testing methods to employ as well as the planning of end points.

The seminar will provide attendees with the knowledge they need to know about current regulatory expectations so they may better prepare their submissions for FDA acceptance — and avoid the time-consuming and costly requirements of additional testing.

Seminar topics will include:

Discussion of the FDA’s draft guidance for industry and FDA staff, “Processing/ Preprocessing Medical Devices in Healthcare Settings”
Methods used for the cleaning and validation of reusable devices
Methods for the disinfection of reusable devices
Methods for the sterilization of reusable devices
Testing requirements
Detailed discussion of endpoints for cleaning validation

The seminar will be presented by Microtest Laboratories, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries, on Wednesday, Dec. 4, 2013, from 9 a.m. to 1 p.m. at the Conference Center at Waltham Woods in Waltham, Mass., just outside Boston. Registration is at 9 a.m. A continental breakfast, break refreshments, and a luncheon are included.

To register, visit the Validation of Reusable Medical Devices seminar event webpage or contact Julie Adamski 1-800-631-1680, ext. 192, or jadamski@microtestlabs.com. Advance registration is $149.

Outsourcing to a Contract Testing Laboratory is Focus of 2013 AAPS Expo Workshop

noreply@blogger.com (Microtest Laboratories) — Mon, 04 Nov 2013 20:43:00 +0000

AGAWAM, MASS. – Nov. 5, 2013 – The strategies and timing of outsourcing pharmaceutical development processes to a contract testing laboratory will be the focus of a mini-workshop at the 2013 AAPS Annual Meeting and Exposition on Nov. 12, 2013.

“Outsourcing to a contract testing laboratory can save pharmaceutical manufacturers both time and money in drug development and commercialization. But knowing the appropriate time and place to outsource can mean the difference between success and failure,” said Shawn Sherry of Microtest Laboratories.

At the mini-workshop, titled “Outsourcing to a Contract Testing Laboratory,” Sherry will overview:

The benefits of using turnkey contract laboratory services
How to establish a smooth working relationship with your laboratory
The importance of the auditing process
Quality system, timeline, and pricing factors
How Microtest Laboratories can help

The mini-workshop will be presented Nov. 12^th from 2:00 p.m. to 2:15 p.m. in the Microtest Laboratories booth, #1325, at the AAPS 2013 Annual Exposition.

Shawn Sherry, Account Development Manager at Microtest Laboratories Inc., has over 11 years’ experience in regulatory microbiology and contract laboratory operations. Sherry holds a BS degree in microbiology and is a nationally registered microbiologist. His experience ranges from compendia testing requirements to aseptic manufacturing, with emphasis on disinfectant qualifications, clean room testing, product testing, and water system validations. He is the co-author of the whitepaper, “Disinfectant Qualifications: Insight and Perspective,” available at http://www.microtestlabs.com/disinfectant-qualifications.

Microtest Laboratories will exhibit in booth #1325 throughout the 2013 AAPS Annual Meeting and Exposition. Microtest Labs is a leader in pharmaceutical contract manufacturing as well as microbiological, analytical, and cleanroom testing services. The company services the pharmaceutical, medical device, and biotechnology industries. Based in Agawam, Mass., Microtest's testing facilities are ISO 9001 and ISO 17025 certified, FDA regulated, and meet all GLP/GMP standards. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

Use of Stability Studies in Drug, Combination Products & Medical Device Development are Reviewed in New Whitepaper

noreply@blogger.com (Microtest Laboratories) — Mon, 21 Oct 2013 16:40:00 +0000

AGAWAM, MASS. — October 22, 2013 —The use of stability testing in new product development — of drug substances, drug products, combination products and some medical devices — is reviewed in a new whitepaper from Microtest Laboratories, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries.

The paper, “The Use of Stability Studies in Pharmaceutical and Combination Product Development” (download from: http://microtestlabs.com/stability-studies), outlines how stability studies can be used to gather valuable information about a new product and prevent unnecessary manufacturing costs and time delays.

Stability studies can help determine formulation and manufacturing strategy, analytical assay development and validation — and help explain unexpected and failing results. They can also provide input to manufacturing controls, and help identify final packaging requirements. The paper examines three specialized stability studies as examples:

Forced degradation studies, which involve exposing the product to predetermined stress conditions in order to intentionally form likely degradation products;
Photostability testing, used to determine the product’s ability to withstand exposure to light without any adverse effects;
Temperature cycling studies, used to assess the impact of temperature changes on the product.

Two case studies, one involving a drug product and one a combination product, are also presented.

The use of stability studies in the development of new drug or combination products can ease both the planning and execution of a development strategy. Moreover, the studies may also help prevent unnecessary costs and time delays due to poor formulations, assay failures, and manufacturing problems.

Download the new whitepaper, “The Use of Stability Studies in Pharmaceutical and Combination Product Development,” from: http://microtestlabs.com/stability-studies.

About Microtest Laboratories

Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

“Combination Products: What You Need to Know” Seminar for Medical Device, Pharmaceutical Manufacturers is Scheduled for October 31st in Boston

noreply@blogger.com (Microtest Laboratories) — Wed, 02 Oct 2013 16:20:00 +0000

A full-day technical seminar designed to assist medical device and pharmaceuticals with what they need to know about manufacturing combinations products, including best practices and applicable FDA regulations, is scheduled for Thursday, October 31^st, in Waltham, Mass., just outside Boston.

Combination products are a large and growing segment of the medical device market. Some analysts estimate they represent more than 30% of all new FDA product submissions. But for manufacturers, the convergence of drugs, biologics, and devices presents a host of best practice and regulatory issues.

Titled “Combination Products: What You Need to Know,” the seminar will outline a realistic approach for manufacturers to navigate the testing, production, and regulatory standards related to the manufacture of combination products. Topics will include:

Combination Products —What You Need To Know: Overview of regulatory hurdles for combination products highlighting the determination of PMOA.
Applications of Lean to Combination Product Manufacturing: Case studies specific to applying lean to manufacturing of combo products for clinical use.
In-Process and Release Testing PTC: Outline of in-process and release testing points to consider during development and specification determination.
EM Monitoring of GMP Manufacturing Space: Current EM procedures for setting up GMP manufacturing.
Choosing the Right CMO: Discussion of best practices to determine a right fit CMO.

“Combination Products: What You Need to Know,” will be presented by Microtest Laboratories, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. The seminar will be held at the Conference Center at Waltham Woods in Waltham, Mass., just outside Boston, on Thursday, October 31, 2013, from 9:00 a.m. to 3:00 p.m. Registration is at 9:00 a.m. Continental breakfast, break refreshments and luncheon is included.

To register, download the form at http://www.microtestlabs.com. Or, contact Julie Adamski at Microtest Laboratories by phone at 1-800-631-1680, ext. 192, or by email at jadamski@microtestlabs.com. The registration fee is $149.

The seminar is one in a continuing series of technical events presented by Microtest Laboratories for medical device and pharmaceutical manufacturers. The seminars tend to fill up quickly so please register early! Follow Microtest Laboratories on Facebook at http://goo.gl/pHNP63, on LinkedIn at http://goo.gl/H8ZLnM or on Twitter @MicrotestLabs.

New FDA Regulations Streamlining the Governance of Combination Products are Detailed in New White Paper

noreply@blogger.com (Microtest Laboratories) — Mon, 09 Sep 2013 15:28:00 +0000

AGAWAM, MASS. — September 10, 2013 — New Federal Food & Drug Administration (FDA) regulations have streamlined the governance of combination products — medical devices embedded with pharmaceutical or biologic components. A new white paper titled "Combination Products 3.0: Applying the New FDA Regulations in 2013" discusses the implications for manufacturers. The whitepaper is available to download at http://microtestlabs.com/combination-products-30.

Combination products are a large and growing segment of the medical device market. Some analysts estimate they represent over 30% of all new FDA product submissions.

"Over the last 10 years, FDA regulatory centers have struggled with the changes and challenges that these new technologies present. For manufacturers, the convergence of drugs, biologics, and devices has created both a host of regulatory issues — and many exciting opportunities," according to Steven Richter, Ph.D, President and Chief Scientific Officer of Microtest Laboratories, Inc., and author of the new white paper.

The new FDA publication, "21 CFR Part 4 — Current Good Manufacturing Practice Requirements for Combination Products," revises regulations by establishing different categories of products. These included single-entity products (such as a drug-eluting stent) and co-packaged products (such as a packaged syringe and pharmaceutical). The rules also distinguished between a drug with a device, a biologic with a device, and a device with an HCT/P.

The new white paper discusses, in detail and example, how the new FDA rules guide a manufacturer into one of two approaches, depending upon the characteristics of their product.

According to Dr. Richter, "the FDA's new streamlined approach for regulating combination products is a big step forward for the practitioner. It applies parts of both the QSR and GMP quality systems in a way that makes sense for the unique characteristics of each combination product. 21 CFR Part 4 closes the gaps in the 2004 guidelines and succinctly clarifies the process for establishing quality systems that ensure compliance and patient health and safety.”

Download the new white paper, “Combination Products 3.0: Applying the New FDA Regulations in 2013,” from http://microtestlabs.com/combination-products-30. The white paper is presented by Microtest Laboratories, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries.

Based in Agawam, Mass., the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information about Microtest Laboratories, visit microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

New Medical Device Polymer Biocompatibility Screening Test Using Zebrafish Embryos to be Discussed at AMI's Medical Grade Polymers 2013

noreply@blogger.com (Microtest Laboratories) — Tue, 03 Sep 2013 16:10:00 +0000

AGAWAM, MASS. – September 3, 2013 – A new test that utilizes Zebrafish (Danio rerio) embryos to screen plastics, composites, and polymers for toxicity in medical device manufacturing will be featured at AMI’s Medical Grade Polymers 2013 technical conference in September.

“The U.S. Food and Drug Administration (FDA) requires testing to assess medical device toxicology and describes which situations may trigger the need for manufacturers to repeat testing or undertake new programs. The dynamics of such testing are rapidly evolving,” according to Steven Richter, Ph.D., president and scientific director of Microtest Laboratories, and a former FDA official.

Dr. Richter developed the new “ZET™ Medical Device Polymer Biocompatibility Screen Test,” at Microtest Laboratories for use by medical device manufacturers and bio-material researchers.

“Zebrafish are extensively used in drug development studies due to their transparent embryos and fast development times. The Zebrafish test demonstrates similarities to mammalian models and humans. Its unique approach to fast-track medical device toxicity screens will save manufacturers time and reduce expenses,” he said.

“Moreover, Microtest’s ZET Test sensitivity has proven to be greater than the USP gold standard test for BPA. In addition, the benefits of ZET surpass both USP cytotoxicity testing and mouse embryo toxicity tests,” he said.

Dr. Richter will present details of the new ZET Test in his presentation, “Biocompatibility Testing: Past, Present, and Future,” on Tuesday, Sept. 17, at 10:10 a.m., at the Applied Market Information LLC (AMI) Medical Grade Polymers 2013 conference. The conference runs Sept. 17-18, at the Crowne Plaza, Boston/Woburn, Mass. For more information, visit http://goo.gl/o9edjx.

For more information about Microtest Laboratories’ new ZET Test, download the white paper, “New Medical Device Polymer Biocompatibility Screening Test Using Zebrafish Embryos (Danio Rerio),” from http://www.microtestlabs.com/zebrafish-test-paper.

About Microtest Laboratories

Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

Microtest Labs Helps Manufacturers of Reusable Medical Devices Meet FDA Cleaning Validation Requirements

noreply@blogger.com (Microtest Laboratories) — Mon, 12 Aug 2013 20:50:00 +0000

AGAWAM, MASS. — August 13, 2013 — Microtest Laboratories is employing new state-of-the-art technology to assist manufacturers of reusable medical devices ensure that they meet U.S. Food and Drug Administration (FDA) requirements for cleaning validations.

Many manufacturers of reusable medical devices only create a set of instructions on manual washing — although automatic washing is gaining popularity. But the FDA requires that manufacturers validate that all sets of cleaning instructions and meet the parameters indicated on a reusable medical device’s labeling.

Microtest Labs acquired a new Getinge 46 series automatic washer/disinfector — used to reprocess soiled reusable medical devices so they can be used again for subsequent procedures. The washer removes soil and performs a low level disinfection of reusable medical devices — thus removing the variability of manual reprocessing.

Technicians at Microtest Lab will use the new system to expand and supplement their consulting services with manufacturers. “By working with manufacturers to develop and validate a set of autowashing parameters, we are helping to ensure that their devices will be processed faster and more reproducible. This saves time and costs — and helps reduce the future possibility of a soiled device being used by a healthcare professional,” said Philip Nosel of Microtest Labs.

Based on its expertise, the company has recently published a management brief summarizing the FDA’s requirements for automatic washing cleaning validation and discussing the benefits of automatic washing. The brief, “Automatic Washer Validation for Medical Devices: Are you in compliance?,” is available for download at http://microtestlabs.com/automatic-washer-validation.

For more information, call Microtest Laboratories 1-413-786-1680 or toll-free 1-800-631-1680.

About Microtest Laboratories

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Press contact: Don Goncalves, 1-781-793-9380, dgoncalves@tizinc.com

Clinical Trial Material Production & Testing: What Your Contract Manufacturing Organization is Not Telling You — White Paper

noreply@blogger.com (Microtest Laboratories) — Tue, 09 Jul 2013 14:13:00 +0000

For pharmaceutical manufacturers, delays in starting a clinical trial program due to issues involving the manufacture of clinical trial material (CTM) and the associated fill/finish and release work can make even the most dogged project managers wince in pain. A new, free white paper recommends a proven process of evaluating a cGMP contract manufacturing organization (CMO) to deliver all the required processes needed to release CTM for clinical trial use.

The new white paper, “Clinical Trial Material Production and Testing: Is Your CMO Providing Everything You Need,” explores what pharmaceutical manufacturers must require from a CMO in terms of capabilities and expertise and the critical roles that the contractor must be able to assume in the clinical trial material manufacturing process.

The white paper is available for download from: http://www.microtestlabs.com/clinical-trial-material-production-testing-paper/.

“In order to keep clinical protocols on time and on budget in the CTM manufacturing process, it’s critical that the selected CMO has comprehensive capabilities that are both in-house and readily available,” notes Alexander Mello, author of the white paper and Director of Project Management, Manufacturing, for Microtest Laboratories, a leader in contract manufacturing, aseptic processing and full service pharmaceutical testing.

“Contracting with a CMO without complete in-house expertise will add unnecessary time to the CTM process. In these cases, performing a GMP audit of the CMO, plus all of the other companies (formulators, laboratories, labelers, etc.) that the CMO uses in the supply chain, will add significantly to the overall cost and time for the technical transfer of the product,” he explains.

The new white paper illustrates how the proper selection of a CMO can help meet product schedules and minimize potential restart activities. The paper reviews the roles that the CMO must be able to play in CTM process, from first steps through the completion, and details the key areas of Raw Materials, Formulation, and Final Drug Product (FDP).

The white paper also discusses how a fully-capable CMO will have the ability to perform all the required processes in CTM – including excipient and API release for GMP manufacture, formulation, in-process testing, environmental monitoring, filter integrity testing, and final release testing.

To download the new, free white paper, “Clinical Trial Material Production and Testing: Is Your CMO Providing Everything You Need,” visit http://www.microtestlabs.com/clinical-trial-material-production-testing-paper/.

Mello, the author of the white paper, is Director of Project Management, Manufacturing, for Microtest Laboratories. Mello’s 15 years of experience span Aseptic Fill/Finish, Microbiology, Method Transfer, Stability of Drug Product, Medical Devices/Combo Devices, and Sterilization Sciences. He holds a graduate degree in Biological Sciences and is a Specialist Microbiologist (NRM).

About Microtest Laboratories

Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

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Medical Device Professionals to Learn “What They Need to Know” about Manufacturing Combinations Products & FDA Regulations at MD&M East Workshop

noreply@blogger.com (Microtest Laboratories) — Tue, 04 Jun 2013 15:24:00 +0000

Medical device professionals will learn what they need to know about manufacturing combinations products and FDA Regulations at a workshop to be featured at MD&M East, the world's largest medical OEM event, in Philadelphia on Tuesday, June 18, 2013.

Titled “Combination Products: What You Need to Know,” the workshop will outline a realistic approach for medical device professionals to use in navigating the regulatory standards required for the approval, marketing, and manufacture of combination products. Topics will include:

Defining a Combination Product
Current and pending FDA regulations re: their approval, marketing, and manufacture
Self-assessing the Primary Mode of Action (PMOA)
Integrating with the FDA through the Request for Designation (RFD) Guidance from the Office of Combination Products (OCP)
GMP issues involving the manufacture of a drug component with a medical device
Differences between medical device cGMPs and pharmaceutical cGMPs: Jargon, regulations, and general culture
Real-world case studies
Questions & answers

Microtest Laboratories Director of Project Management, Manufacturing, Alex Mello will lead the workshop. Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Mello has more than 20 years of experience in Aseptic Fill/Finish, Microbiology, Method Transfer, Stability of Drug Product, Medical Devices/Combo Products, and Sterilization Sciences. He holds a graduate degree in Biological Sciences and is a Specialist Microbiologist (NRCM).

“Combination Products: What You Need to Know” will be featured at MD&M East as part of the event’s “Innovation Briefs” series. The workshop will be held on Tuesday, June 18 at 1 p.m. in booth #957. Attendance is free for MD&M East guests and participants. For more information, contact Microtest Laboratories by phone at 1-800-631-1680 or by email at amello@microtestlabs.com.

About Microtest Laboratories

Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

Microbiology Quality Control Seminar to Assist Medical Device Manufacturers Validate Sterilization, Cleaning Processes

noreply@blogger.com (Microtest Laboratories) — Fri, 19 Apr 2013 14:29:00 +0000

A seminar on microbiology quality control — designed to help medical device manufacturers validate sterilization and cleaning processes, and maintain controlled environments — will be held on Thursday, May 16, in Boston.

“For today's medical device manufacturers, the challenge is to validate their sterilization and cleaning processes to ensure patient safety and product integrity. This seminar will focus on a host of issues pertaining to the sterilization of medical devices including sterilization validation, bioburden, sterility, and endotoxin testing, as well as submitting samples to a contract testing laboratory,” said Steven Richter, Ph.D., president and scientific director of Microtest Laboratories, which is hosting the event.

Topics at the “Microbiology Quality Control Seminar” will include:

MICRO 101
Sterilization Validation
Bioburden Testing
Sterility Testing
Endotoxin Testing
Testing Sample Submissions

The event will be held at the MIT Endicott House in Boston, Mass., on Thursday, May 16, 2013, from 9 a.m. to 3:30 p.m. Registration is 9 a.m. to 9:45 a.m. A networking reception and lunch are included.

To register, download the form from http://www.microtestlabs.com/pdfs/seminar-registration-form_1305.pdf. Or, contact Julie Adamski at Microtest Laboratories by phone at 1-800-631-1680, ext. 192, or by email at jadamski@microtestlabs.com. The registration fee is $149.

About Microtest Laboratories

Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

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New White Paper Details What Compounding Pharmacies Must Know to Prepare for FDA Inspections

noreply@blogger.com (Microtest Laboratories) — Thu, 11 Apr 2013 19:13:00 +0000

In anticipation of new US Food and Drug Administration (FDA) regulations, many companies are working toward correcting potential problems and attaining USP <797> compliance. A new white paper addresses the issues that compounding pharmacies must address prior to undergoing an FDA or state inspection. Titled, “Compounding Pharmacy Inspections: What You Must Know to Prepare for the FDA,” it is available to download at http://www.microtestlabs.com/whitepaper from Microtest Laboratories.

“The FDA requires all compounding pharmacies to comply with USP section <797>, which outlines the different standards and regulations for environmental control, testing, and personnel training. Currently, the operations of large-scale compounders do not fall under the scrutiny and regulation of the FDA. However, these facilities may now face inspections from both the state regulatory authorities and the federal government,” said white paper author Steven Richter, Ph.D., president and scientific director of Microtest Laboratories — and a former FDA official.

In the white paper, Dr. Richter advises compounding pharmacies on the critical issues to resolve prior to an FDA or state inspection, including sterile compounding regulations, quality testing, sterility testing of compounded articles, disinfectant validations, and endotoxin testing.

“In the aftermath of the NECC case, FDA and state actions regarding compounding pharmacies are relatively certain: regulations and inspections will both tighten and increase. The FDA, in some instances, will assume the role of lead auditor for the compounding pharmacy’s operations,” Dr. Richter said. “It is critical for compounding pharmacies to maintain a state of control in their controlled environments. While there may always be excursions, it is the actions that are undertaken after the excursions that will influence an inspector’s responses and observations during an on-site investigation and inspection.”

Download a copy of “Compounding Pharmacy Inspections: What You Must Know to Prepare for the FDA,” at http://www.microtestlabs.com/whitepaper. Or, request a copy by calling Microtest Laboratories 1-413-786-1680 or toll-free 1-800-631-1680.

Microtest Laboratories is a Massachusetts-based, FDA-audited company with a history of exceptional regulatory compliance. Microtest Labs’ environmental sciences group helps clients maintain control of their controlled environments and is a proven resource for contamination testing needs arising from the manufacturing of medical devices or pharmaceuticals, as well as sterile compounding in hospital pharmacies.

Gov. Deval Patrick announces life sciences funding at Holyoke Community College

noreply@blogger.com (Microtest Laboratories) — Fri, 01 Mar 2013 19:05:00 +0000

On Thursday, Feb. 28, Massachusetts Gov. Deval Patrick announced more than $9 million in grants for life sciences-related capital projects in Western Massachusetts, including funding for Holyoke Community College.

At the announcement, Holyoke Community College President William F. Messner "thanked Holyoke Community College graduate Steve Richter for his help in securing the grant for the college. Richter, president and scientific director of Microtest Labs in Agawam, has long cited the need for a trained biotech workforce. His company, which tests medications, has more than 100 employees. 'He's really the one who really got it for us,' Messner said."

Read more on masslive.com: http://www.masslive.com/business-news/index.ssf/2013/02/gov_patrick_announces_life_sciences_fund.html

“Processing Compounded Sterile Products,” Information Session Set for Dec. 12 in Springfield, Mass.

noreply@blogger.com (Microtest Laboratories) — Wed, 05 Dec 2012 14:06:00 +0000

AGAWAM, MASS. — Dec. 5, 2012 — A free information session focusing on the challenges of meeting U.S. regulations mandating tighter control of sterile preparations in compounding pharmacies, has been scheduled for Dec. 12, 2012, in Springfield, Mass.

The session, “Processing Compounded Sterile Products,” will be presented by Microtest Laboratories, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries.

Designed for managers of controlled environments in the pharmaceutical industry, experts in the session will offer technical presentations, practical advice, and solutions on issues relating to General Chapter , including:

Environment contamination control and testing
FDA aseptic guidance
USP <797> and <1116>
Technician training and qualification requirements
Product testing that includes: sterility/endotoxin, potency/ID, beyond use dating
Assessing current practices and next steps

“Processing Compounded Sterile Products” is scheduled for Wednesday, December 12, 2012, at the Hilton Garden Inn, 800 Hall of Fame Avenue, Springfield, Mass., from 9:30 to 11:30 a.m. Registration is at 9 a.m. The session is free — complimentary entry, parking, and refreshments will be provided — but space is limited and advance reservations are required. For more information or to reserve admission, visit the Microtest Laboratories website athttp://www.microtestlabs.com/pdfs/seminar-registration-form_1212.pdf, call 1-800-631-1680 extension 192, or email jadamski@microtestlabs.com.

Microtest Laboratories is a Massachusetts-based, FDA-audited company with a history of exceptional regulatory compliance. Microtest’s environmental sciences group helps its clients maintain control of their controlled environments and is a proven resource for contamination testing needs arising from the manufacturing of medical devices or pharmaceuticals, as well as sterile compounding in hospital pharmacies.

About Microtest Laboratories

Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

New White Paper Assists Medical Device Manufacturers with Changes to FDA Endotoxin Testing Guidelines

noreply@blogger.com (Microtest Laboratories) — Wed, 24 Oct 2012 14:10:00 +0000

AGAWAM, MASS. —October 24, 2012 — A new white paper is available to assist medical device manufacturers with understanding recent changes to the U.S. Food and Drug Administration’s (FDA) thinking regarding endotoxin testing. The paper is available to download from the Web at http://www.microtestlabs.com/medical-device-endotoxin-testing-paper.

Titled “FDA Updates Medical Device Endotoxin Testing Program (New Guidance),” the new white paper is authored by Steven G. Richter, Ph.D., a former FDA official, and President and Chief Scientific Officer of Microtest Laboratories, Inc., a leading contract testing laboratory.

In the paper, Dr. Richter discusses the FDA’s recently published document, “Guidance of Industry Pyrogen and Endotoxin Testing: Questions and Answers.” The FDA document replaced the agency’s 1987 Endotoxin Guidelines — now considered out of date as a result of changes in the USP and pharmaceutical dosage forms. It presents the agency’s current position regarding pyrogen and bacterial endotoxin testing requirements for pharmaceuticals, biologics, and medical devices. Medical devices that contact circulating blood or cerebrospinal fluid, or are used with intraocular products or in vitro fertilization procedures, are required to be endotoxin-free.

In his new white paper, Dr. Richter reviews the FDA’s updated guidelines on endotoxin testing and explains how they relate to medical devices. Since the majority of pyrogens found on medical devices are bacterial in nature, the paper focuses on those contaminates.

Some medical devices that are required by the FDA to be tested for endotoxin are:

• Intravenous catheters and tubing

• Cardiac stents and angioplasty balloons

• Certain implants such as pacemakers/defibrillators

• Spinal catheters

• Transfusion catheters

• Intraocular lens implants

• Cranial drills

• Perfusion tubing

• Dialysis tubing and filters

• Vascular grafts

• In vitro fertilization catheters

Download a copy of the new white paper, “FDA Updates Medical Device Endotoxin Testing Program (New Guidance),” from the Microtest Laboratories website at http://www.microtestlabs.com/medical-device-endotoxin-testing-paper. Or, request a copy by calling 1-413-786-1680 or toll-free 1-800-631-1680.

About Microtest Laboratories

Microtest Laboratories is a full-service medical device testing laboratory and provider of related services for the medical device, pharmaceutical, and biotechnology industries. Medical device testing is performed in-house by seasoned regulatory microbiologists and chemists under strict GMP/GLP regulations. Microtest is both ISO 9000 and 17025 certified. Testing services include bioburden, sterility, endotoxin, accelerated aging, and toxicity (ISO 10993). In addition, Microtest recently introduced a fast-track test to screen plastics and polymers in medical devices for toxicity using Zebrafish embryos.

Based in Agawam, Massachusetts, USA, the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com, or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow on Twitter at http://twitter.com/MicrotestLabs.

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New Scope of Reusable Medical Device Cleaning Validations is Examined in New White Paper from Microtest Laboratories

noreply@blogger.com (Microtest Laboratories) — Tue, 02 Oct 2012 13:37:00 +0000

AGAWAM, MASS. – October 2, 2012 – The new scope of cleaning validations for the manufacturers of reusable medical devices is examined in a white paper available for download from http://www.microtestlabs.com/new-scope-cleaning-validation-paper.

“Cleaning validation for reusable medical devices is an important step in proving their safety. Available guidance documents now indicate that the traditional method of validating cleanliness, spore log reduction, will no longer be acceptable. Analytical assays capable of providing quantitative results will now be required instead,” writes white paper author Patrick Kenny, Manager of Analytical Services, Microtest Laboratories.

In the new white paper, “The New Scope of Reusable Medical Device Cleaning Validations,” Kenny notes that “although a new requirement for reusable medical devices, these tests are traditional analytical assays that are performed routinely on other types of samples.”

“An effective protocol and report that includes justifications for the test soil and assays chosen, as well as thorough documentation of all parameters used in the validation, will help ensure success for the device’s submission,” Kenny notes.

The paper discusses cleaning validation analytical assays as well as various methods and scenarios related to performing the validation. Recommendations are based on several key documents relating to reusable device cleaning validations that are either in draft or final form. They include AAMI document TIR30:2003, a comprehensive guide to medical device cleaning validations. TIR30 is currently in revision, and an updated version is scheduled for 2011 release.

Download the white paper, “The New Scope of Reusable Medical Device Cleaning Validations,” from the Microtest Laboratories website at http://www.microtestlabs.com/new-scope-cleaning-validation-paper.

Kenny holds a M.S. degree in Chemistry and has spent the past 13 years working in QC, R&D and manufacturing laboratories. At Microtest, Kenny leads the services group performing medical device and pharmaceutical analytical testing for companies worldwide.

About Microtest Laboratories

Boston Seminar to Assist Medical Device & Pharmaceutical Manufacturers with Environmental Monitoring, Risk-Assessment

noreply@blogger.com (Microtest Laboratories) — Tue, 25 Sep 2012 13:45:00 +0000

Microtest Laboratories will present an environmental monitoring seminar and risk-assessment workshop to assist medical device and pharmaceutical manufacturers with building, validating, and maintaining their clean rooms and sterile manufacturing environments.

Titled “Environmental Monitoring Seminar and Risk-Assessment Workshop,” the event will provide practical information and the latest techniques on cleaning and disinfection programs designed to maintain aseptic conditions and prevent microbial contamination.

The event will be held at the MIT Endicott House in Dedham, Mass. — just outside Boston — on Wednesday, October 24, 2012, from 10 a.m. to 2 p.m.

At the event, attendees will:

Participate in a hands-on workshop that focuses on risk assessment in the clean room
Discover the best practices for qualifying and maintaining a clean room facility
Identify and assess the risks commonly found in a clean room environment
Test the information they've learned in a mock clean room floor plan exercise

A networking reception, and lunch, is included. For more information, or to RSVP, contact Julie Adamski at Microtest Laboratories by phone at 1-800-631-1680, ext. 192, or by email at jadamski@microtestlabs.com. Registration for the event is $149.

The event is one in a series of technical seminars and workshops for medical device and pharmaceutical manufacturers presented by Microtest Laboratories, a Mass.-based, FDA-audited company with a history of exceptional regulatory compliance. Microtest’s environmental sciences group helps its clients maintain control of their controlled environments and is a proven resource for contamination testing needs arising from the manufacturing of medical devices or pharmaceuticals, as well as sterile compounding in hospital pharmacies.

About Microtest Laboratories

Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

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Use Notebook Studies to Ensure Successful Reusable Device Cleaning Validations, Recommends Microtest Laboratories

noreply@blogger.com (Microtest Laboratories) — Tue, 14 Aug 2012 13:13:00 +0000

AGAWAM, MASS. —August 14, 2012 — A new management brief from Microtest Laboratories recommends that medical device manufacturers use notebook studies to help ensure successful reusable device cleaning validations. The lab bases the advice on its performance of validations for various types of medical instruments over the years.

The brief discusses the document, “FDA Draft Guidance for Industry and Staff, Processing /Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling,” which was released in May 2011.

“Even though it’s labeled as a draft, experience has shown that most reusable device cleaning validations are being evaluated based on this document,” said Patrick Kenny, manager of analytical services at Microtest Laboratories — and author of the new brief titled, “Notebook Studies to Ensure Successful Reusable Device Cleaning Validations.”

Kenny’s brief focuses on areas of the FDA guidance document that are causing difficulties in cleaning validations, and demonstrates how pre-validation laboratory work can help save time and money. It also identifies areas that can cause issues during validations if they are not thoroughly addressed prior to initiating the protocol. These include:

The use of worst-case conditions
The switch from microbial-based assays to chemical-based assays
The determination of an acceptable residual level
The validation of a reusable device’s cleaning instructions

“The good news is that almost all of these issues can be eliminated with some up-front work,” Kenny said. “And this preparatory work can best be performed by notebook studies prior to initiating GLP studies. The information obtained in these relatively quick studies often saves significant time later in the filing process.”

“In short, we recommend the use of notebook studies prior to beginning the validation to eliminate as many unknowns as possible,” he said.

To obtain a copy of the new management brief, “Notebook Studies to Ensure Successful Reusable Device Cleaning Validations,” visit http://www.microtestlabs.com/notebook-studies-brief or call 1-413-786-1680, or toll-free 1-800-631-1680.

About Microtest Laboratories

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