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About RMG- Rapid Mixer Granulator - Part - 4/4

2021-02-07T15:36:00.004+05:30

Components & Process parts of RMG:

Here mention Components & Process parts of RMG not limited. It’s varying as per manufacturer of machine.

RMG consists of different Components like:

Mixing chamber
Impeller
Chopper
Binder Inlet port
End Point
Top Lid
Discharge point
Purging air
Filter Assembly
Co-mill
CIP (Clean-in-Place) / WIP (Wash-in-Place) System
Control panel like HMI, IPC or PLC Programmable Logic Controller (PLC)

Other Information about RMG:

PRINCIPLE OF RAPID MIXER GRANULATOR
General Process in RMG
Calculate For working capacity of the Rapid mixture granulator?
Process variable of RMG:
Advantage:
Disadvantage:
Safety Features

1 : PRINCIPLE OF RAPID MIXER GRANULATOR

The Rapid Mixer Granulator is mixing equipment that contains bottom entry agitator/impeller and side-mounted chopper for effective granulation of materials in various industries. The RMG Machine is used for the applications of wet mixing, dry blending/mixing, and preparation of dough & granulation.

After loading the ingredients in the RMG mixing chamber the formation of granules occurs by the impeller which sets the entire mixture in a spinning tumbling motion which results in distribution of all dry granules as well as Wet granules.

In Rapid mixer granulator Mixing ,Densification and Agglomeration is achieved using Shear mixing(Breaking inter-molecular forces) and Compaction forces exerted by Impeller on the powder mass.

The components of the RMG (impeller and chopper) are highly responsible for the wet granulation process.

Rapid mixture granulator works on agitation, tumbling. The impeller is responsible for uniformly mixing wet granules and copper helps in a break or reduced particle size. At the starting process or during binder addition impeller and chopper are operated at low speed and then after the formation of wet mass, they are operated at high speed to make the desired granule size.

Dry mixing is done at high speed after adding all dispensed materials into RMG.

2 : General Process in RMG

Dry mixing takes about 3-5 minutes to mix the ingredients; wet mixing takes 5-10 minutes to make the material’s wet mass. The granulation process takes 5-10 minutes to 0.5 mm to 1.5 mm sized granules.

Mixing time consumed in processing is depends upon the ingredient’s quantity and their particle size.

Dry Mixing: Impeller operated at a lower speed (75 RPM ) or as per BMR at starting during dry mixing of dispensed materials as per Product – BMR. Its time depend on BMR like 5 to 10 min for uniform dry mixing before binding for uniform granules. After completion of Dry Mixing go for Wet Mixing or Binding.

Binder addition: Add the Paste or Binder solution through binder inlet or addition port by operated impeller at a validate speed of impeller rpm for products or as given in batch manufacturing records (BMR). ( RPM: 75 to 150 RPM)

3 : Calculate For working capacity of the Rapid mixture granulator?

For this first calculate the bulk density of powder to be mixed, then it multiplies by the capacity in liters (provided by the vendor), for eg.

working capacity in a liter is 600 liter and its working volume is 80% means 480 liters and bulk density is 0.5 then capacity in kgs is 480*0.5= 240 kg.

so we can make a batch of 240 kg materials in modal of 600 liters RMG.

4 : Process variable of RMG:

Time was taken during the mixing process

Speed of impeller

Speed of chopper

Binder solution quantity

Impeller rotation speed

Chopper rotation speed

Liquid flow rate

Load of the mixer

Liquid addition method

Wet-massing time (subsequent of liquid addition time)

5. Advantage:

Easy to operate from PLC panel

Required less time for clean and easy to clean

Safety is adequate

Standardized according to GMP

Self-discharge

Mixing can be performed at large scale at less time

Can produce Homogenous mass and later on granules in less time.

6. Disadvantage:

High noise level

Required large space to install

During the process, temperature becomes high because of friction force between granules.

High in cost

Working height is more, so required more effort to add materials.

7. SAFETY FEATURES

All belts, pulleys and transmission system are adequately guarded with suitable covers.

Machine can't be started if the top lid is open due to a proximity sensor.

Machine can't be started if the air pressure is below the set value.

Machine can't be started if the discharge flange is open for cleaning due to a proximity sensor.

If main impeller is lifted upward for cleaning or for visual inspection during validation of cleaning, the machine can't be switched ON.

Machine can't be started unless Fluid bed trolley us kept underneath discharge assembly.

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About RMG- Rapid Mixer Granulator - Part - 1/4
About RMG- Rapid Mixer Granulator - Part - 2/4
About RMG- Rapid Mixer Granulator - Part - 3/4

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About RMG- Rapid Mixer Granulator - Part - 3/4

2021-02-07T15:27:00.006+05:30

Components & Process parts of RMG:

Here mention Components & Process parts of RMG not limited. It’s varying as per manufacturer of machine.

RMG consists of different Components like:

Mixing chamber
Impeller
Chopper
Binder Inlet port
End Point
Top Lid
Discharge point
Purging air
Filter Assembly
Co-mill
CIP (Clean-in-Place) / WIP (Wash-in-Place) System
Control panel like HMI, IPC or PLC Programmable Logic Controller (PLC)

Other Information about RMG:

PRINCIPLE OF RAPID MIXER GRANULATOR
General Process in RMG
Calculate For working capacity of the Rapid mixture granulator?
Process variable of RMG:
Advantage:
Disadvantage:
Safety Features

11. CIP / WIP System

CIP means a totally automatic cleaning sequence with no manual involvement, whereas as WIP includes some manual intervention.

In practical terms CIP requires high levels of validation, against WIP which requires less stringent validation.

CIP/WIP system have inlet connection with pneumatic operated valve for Purified water, Hot water, with pressurized pump, which are connected with spraying ball with supply pipe on the machine. The complete CIP/WIP system is operated by PLC controls system with touch screen PLC. PLC controls system is working as per set time for washing cycle of the inlet & outlet as per requirements & cleaning SOP of Machine.

12. Control Panel

As control panel in pharma industry mainly HMI (Human Machine Interface), IPC (Industrial PC) or PLC (Programmable Logic Controller) used. All are used for control the all process parameter for produce the product as per BMR.

The Control panel is mounted on the platform and has On/Off, fast, slow, and auto/manual controls. There are a timer, indicator lights, controls for discharge opening / closing, ammeter/voltmeter for motors, air regulator and pressure gauge, air filter, and PLC control panel.

HMI-IPC-PLC has option to set all parameter limits as per BMR, so beyond the limit machine cannot run and stop the failure of product.

HMI is short for Human Machine Interface. We use them in industry to control and monitor machines. The job of this is it to translate the signals and intentions from a human into signals of electric for the information system of machine to use. Therefore in doing so, lets the human operator to create interactive changes in the data and software process.

Generally PLC have SCADA system can store all data of entire process and can’t change in it.

Its follow 21CFR.

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About RMG- Rapid Mixer Granulator - Part - 1/4
About RMG- Rapid Mixer Granulator - Part - 2/4
About RMG- Rapid Mixer Granulator - Part - 4/4

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About RMG- Rapid Mixer Granulator - Part - 2/4

2021-02-07T15:23:00.005+05:30

Components & Process parts of RMG:

Here mention Components & Process parts of RMG not limited. It’s varying as per manufacturer of machine.

RMG consists of different Components like:

Mixing chamber
Impeller
Chopper
Binder Inlet port
End Point
Top Lid
Discharge point
Purging air
Filter Assembly
Co-mill
CIP (Clean-in-Place) / WIP (Wash-in-Place) System
Control panel like HMI, IPC or PLC Programmable Logic Controller (PLC)

Other Information about RMG:

PRINCIPLE OF RAPID MIXER GRANULATOR
General Process in RMG
Calculate For working capacity of the Rapid mixture granulator?
Process variable of RMG:
Advantage:
Disadvantage:
Safety Features

6. TOP LID

Top Lid available on RMG mixing chamber for close or seal properly mixing chamber during entire Dry mixing-Wet Mixing-Kneading process.

Top lid is operable by hand with the help of balancing weight. It can also be operated by means of air cylinder instead of using balance weight. Top lid consist of Food Grade Gasket which assure proper seal of machine from top to avoid any loss during binding process.

Mixing bowl top lid has two openings, one for addition of binder and other for viewing granulation process. An air vent is provided to release pressure which rise during entire process in the mixing chamber during mixing and granulation by a filter of approx 5 micron. It is easily washable for dedicated as per product or used deposable bag.

7. Discharge point

The discharge port is mounted horizontally into the mixing chamber with vertical downward opening. Granules are unloaded in the FBP container through the discharge port or direct to FBP cell by vacuum transfer system. Opening of discharge port is operated by pneumatic cylinder (compressed air cylinder) that requires approx 3-5 kg/cm² pressure of compress air.

Discharge point in some RMG open only when FBD/FBP container placed at lower of discharge point and container touch with discharge point sensor available at RMG near to discharge point.

8. Purging Air

Purging air coming from gasket presents at the impeller and chopper at pressure of 5-6 kg/cm²to preventing contamination. If Purging Air stopped or below than set pressure, then machine will stopped with alarm and chances are Material can enter inside that from where purging air coming it will result in cross contamination.

Purging air is used to flush the industrial process equipment with clean air. Purging Air helps to keep the surfaces of RMG (Granulation Machine) clean and help in maintaining its effective performance.

9. Filter Assembly

Filter assembly is fitted on the top of LID, in this vent air filter is placed which allows the purging air to leave the Mixing chamber and retains the granules inside.

For air vent filter Product dedicated bag, disposal bag or SS Filter (5 to 10 micron size) used as per Product or as per industry or machine model.

10. Co-mill

Co-mill fitted at end of discharge point (as per model of RMG). Co-Mill is used for high speed SHREDDING, SIZING, and GRINDING of wet Granules. Its speed and size of screen use as per product specification. Generally size of screen used in co-mill for wet granules 6 mm to 10 mm.

Online CO-Mill on the discharge port that reduces the oversized lumps. It results in a reduction of drying time. As the lumps are small products, they can be uniformly dried at lower temperatures. Hence providing it a longer shelf life and eliminating casing & capping of tablets due to improper drying.

Click here for Next Contents:

About RMG- Rapid Mixer Granulator - Part - 1/4
About RMG- Rapid Mixer Granulator - Part - 3/4
About RMG- Rapid Mixer Granulator - Part - 4/4

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About RMG- Rapid Mixer Granulator - Part - 1/4

2021-02-03T12:00:00.006+05:30

About Rapid Mixer Granulator (RMG)

Rapid Mixer Granulator are also known as the High Shear Mixer Granulator use for dry mixing & wet granulation in pharmaceutical Industry for mix the pharmaceutical ingredients and make the uniform wet mass granules/mixing or dry mixing. As the name suggests, this machine performs two operations - Mixing and Granulating.

Granulation is an important process in tablet manufacturing. As a result of the granulation process, the particles stick together firmly by addition of binder (paste or solution ) which helps in increasing the particle size. High shear granulation machine efficiently executes the process of fast dry & wet mixing, and granulating of the powder.

RMG UTILIZE FOR TWO TYPE GRANULATION PROCESS

1. DRY GRANULATION PROCESS

The dry granulation process is used for uniform mixing without addition of any binder. It is most suitable for the materials that are moisture-sensitive, heat-sensitive or do not compress well due moisture issue.

2. WET GRANULATION PROCESS

Wet granulation is the process of adding the binder ( paste or solution) to dry powders, which involves the massing of dry powder particles with the help of granulating fluid/binder. The wet granulator is used for the production of wet granules. The complexity of the wet granulation process depends on the characteristics of powder and the equipment.

Rapid Mixer Granulator primarily used for the manufacturing of tablets, Capsule filling powder manufacturing process which requires homogenous mixing, controlled granule size, and at the same time assuring a great reduction in processing time and gives uniform mixing of all ingredients.

Components & Process parts of RMG:

Here mention Components & Process parts of RMG not limited. It’s varying as per manufacturer of machine.

RMG consists of different Components like:

Mixing chamber
Impeller
Chopper
Binder Inlet port
End Point
Top Lid
Discharge point
Purging air
Filter Assembly
Co-mill
CIP (Clean-in-Place) / WIP (Wash-in-Place) System
Control panel like HMI, IPC or PLC Programmable Logic Controller (PLC)

Other Information about RMG:

PRINCIPLE OF RAPID MIXER GRANULATOR
General Process in RMG
Calculate For working capacity of the Rapid mixture granulator?
Process variable of RMG:
Advantage:
Disadvantage:
Safety Features

Components:

1. Mixing chamber

Most of the Rapid Mixer Granulator consists of a mixing bowl, a three-bladed impeller, and an auxiliary chopper. The mixing bowl can be jacketed for heating or cooling the contents in the bowl, by circulating hot or cool liquid or steam through the jacket as per product requirement and non jacket mixing type chamber widely used in pharmaceutical industry.

There are three types of mixing chambers based on their design used in pharma industry.

Mixing chamber Shape

Conical shape

Dome shape

Circular shape

The basic aim behind all the shapes is to eliminate the dead points and wall adhesion i.e. the powder may not adhere to wall from where it cannot detach leading to inefficient granulation as well as mixing. Hence the shape of mixing chamber has big effect on Product binding process.

2. Impeller:

The impeller is designed at bottom of the flat mixing chamber. An impeller is employed to mix the dry powder and spread the granulating fluid. The impeller of the rapid mixer granulator normally rotates at a speed ranging from (Slow- 75 RPM to fast 150 RPM). The impeller mixes the dry powder uniformly and prepares wet mass after the addition of the binder. It consists of large blades responsible for mix & for lifting the materials.

The mixing is achieved by paddle type impeller blades spinning close to bottom of the mixing bowl. The impeller blades are angled in a way that sets the entire mixture in a whirling - rising - tumbling motion ensuring a quick and even distribution of all dry components which leads to an even wetting of every granule.

The speed of Impeller should be high enough to cause material will in Roping flow motion as slow speed result material get Bumping motion of powder and leads to Inefficient mixing.

A- Bumping motion

At lower speed (Bumping motion) of impeller, continue the resulted granules have no uniform mixing with binder or paste which may result failure of product.

B- Roping motion

At higher speed of Impeller (Roping motion), due to roping motion size of granules increases and if high speed is for longer time collisions between the particles the size of granules will decrease.

The gap between base of mixing chamber and impeller is around 2.0 mm which is enough that the granules pass below the impeller blade without breaking.

3. CHOPPER

Copper fixed at side mounted bottom side of mixing chamber. Chopper has very sharp small blades which are specially designed to cut the wet lumps of material into very small piece which are then mixed by impellers and lead uniform wet granules or dry mix material.

The primary function of chopper is to cuts the lumps into smaller fragments those are mixed equally by impeller and aids the bowl or sprayed onto the powder to achieve a more homogeneous liquid distribution.

The use of chopper should not be done always as we know the chopper will break the granules.

Firstly look weather active is free flowing or cohesive, weather it lumps or not .Chopper should be used if active is cohesive or forms lumps at the minimum speed after solution addition.

Chopper used for break/cuts the large lumps formed by impeller in small granules for make uniform granules which occur due to Binder (Paste or Solution) addition or during Kneading of wet mass till uniform granules.

RPM of Chopper (Slow 1440 to Fast 2880) use for product as per BMR instruction.

The process of convert wet mass into granules is called Kneading.

4. Binder inlet port for Binder (Paste or Solution) addition

Binder (Paste or Solution) should be added slowly not suddenly though Binder inlet port available on top of lid of RMG , as sudden addition of binder leads to inefficient distribution of binder and may cause hardness variation in tablet. It’s also leads to variation of drying, during drying process in FBD/FBE/FBP which result in uneven LOD (Loss on Drying) of final product.

For best result of granules, Binder addition should do by peristaltic pumps. So prior do validations of Peristaltic pump how much binder will go in one minute.

5. END POINT

A- For Dry Mixing: Its Time base process only. In this process Fix TIME and RPM for Impeller and chopper available.

B- For Wet Mixing: is Ampere load base process mostly.

Ampere load on Impeller and Chopper I.E the current which is used by Impeller and chopper motor to rotate when granules are formed.

Ampere load is high in beginning when granulation starts as motors need more power and decreases as end point is reached.

End point could also be determined by ensuring the Vortex formation generally done by Research and Development personnel during Trial or Validation (3-batch) batches.

Take wet granules in hand and close the fist then open and break it throughout thumb, called a banana breaking method.

Ampere load mentions as per BMR when achieved stop the machine and record it from PLC or printout.

As material get dense or bind more and more so it's increased hence vaildation require for each process to avoid failure of batch.

Click here for Next Contents:

About RMG- Rapid Mixer Granulator - Part - 2/4
About RMG- Rapid Mixer Granulator - Part - 3/4
About RMG- Rapid Mixer Granulator - Part - 4/4

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