Rapid mixer graqnulator
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Transcript of Rapid mixer graqnulator
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Rapid Mixer Granulator
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The Rapid Mixer Granulator is a multi-purpose processor equally suitable for high speed dispersion of dry powders, aqueous or solvent granulations, and effervescent products and melt pelletization.
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Blending and wet massing is accomplished by high mechanical agitation by an impeller and chopper. Mixing, densification, and agglomeration of wetted materials are achieved through shearing and compaction forces exerted by the impeller.
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The primary function of chopper is to cuts lumps into smaller fragments and aids the bowl or sprayed onto the powder to achieve a more homogeneous liquid distribution.
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VARIABLES :PROCESS VARIABLES :• Impeller rotation speed • Chopper rotation speed • Liquid flow rate • Load of the mixer • Liquid addition method • Wet-massing time (subsequent of liquid addition
time)
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PRODUCT VARIABLES :Amount of liquid binder Characteristics of liquid binder
Surface tension Viscosity Adhesiveness
Characteristics of the feed materials Particle size and size distribution Particle specific surface area Solubility in the liquid binder Wettability
Packing properties
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Mixing Bowl
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VALIDATION
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Validation mainly includes:
Installation qualification (IQ)Operational qualification (OQ)Performance qualification (PQ)
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Equipment installation site:
Equipment is installed in the location as specified. Equipment is installed as per the supplier
instruction. Packing debris are removed As Built drawing is prepared and verified
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Installation Qualification Procedure :
Test Equipment:
Spirit level For checking leveling of equipment
Multi meter For checking electrical supply
Molybdenum test kit To confirm material of construction of the Stainless Steel 316 quality
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Protocol Approval :
• Objective• Critical Process control variables• Test Program and Acceptance criteria• Sampling points• Qualification results• Final Report• Report Approval
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OBJECTIVE: To verify that the utility, environment, equipment and
support system produces the required output by integrating procedures, personnel, systems and materials.
To verify the performance of the Rapid Mixer Granulator - (RMG) for maximum occupancy capacity of 80%, minimum occupancy capacity 30% and intermediate occupancy capacity 55% based on 0.5 w/v bulk density, by adding lactose and Ponceau 4R supra of 1% in RMG and estimate the colour content uniformity in blend at different time intervals.
To verify the performance of Rapid Mixer Granulator - (RMG) for a specific size by granulating lactose with HPMC solution and observe amperage and granules consistency at different time intervals.
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S.S.NoNo
Operation stageOperation stage Control variablesControl variables Measured parametersMeasured parameters
11 Dry MixingDry Mixing Load sizeLoad sizeMixing timeMixing time
Content uniformity Content uniformity
22 Wet MixingWet Mixing Impeller speed, chopper speedImpeller speed, chopper speedGranulation timeGranulation timeAmount of granulation fluidAmount of granulation fluid
Water content/LODWater content/LODGranules appearance Granules appearance Amperage /torqueAmperage /torque
CRITICAL PROCESS CONTROL VARIABLES:
Process control variables of dry mixing, wet mixing operations and measured parameters are identified as follows
Performance of Rapid Mixer Granulator shall be verified at different control variables such as load size, and mixing time.
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Test program and acceptance criteria:
Objective: To verify the performance of the Rapid Mixer
Granulator (150 lts) for maximum, minimum and intermediate occupancy capacities and at different mixing intervals.
Granulating performance for maximum capacity at different control process parameters
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Procedure (dry mixing): Add Lactose and Ponceau 4R supra (sifted through 40#) into
Rapid Mixer Granulator and mix the material for a period of 20 minutes.
Collect samples in duplicate each equivalent to 2gms using unit dose sampler from 5 different locations (shown in diagram and transfer in to individual labeled glass vials.
Collect the samples at different time intervals of 5, 10, 15 and 20 minutes
Submit the samples for analysis of colour content. Analyse the sample as per the analytical procedure. Record the results in qualification result data sheets.
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Sampling points in rapid mixer granulator
4
1 2
3
5
1.Top Left2.Top Right3.Middle4.Bottom Front5.Bottom Rear
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Analysis procedure:Sample preparation: Weigh sample equivalent to 10 mg of Ponceau 4 R supra and
transfer into 200ml volumetric flask add 100ml of water and sonicate for 5 minutes to dissolve completely, then dilute up to the mark with water. Filter the solution and dilute 10ml of filtrate to 50 ml with water.
Procedure: Measure the absorbance at 506nm using UV spectrophotometer.
Calculate the % of colour content using following formula.Acceptance Criteria:Colour content (assay) of all samples should be in between 90 -
110 %The average of assay results at each interval should be in between
95 -105 %Content uniformity of 5 samples RSD should not be more than 4%
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Procedure (wet mixing): Add specified quantity of HPMC in purified water and dissolve
completely.Take specified quantity of Lactose monohydrate (sifted through
#40) into RMG, add above HPMC solution and granulate at slow speed till the required consistent granules formed.
Record the time of granulation at different intervals (after 5minutes and every after 2minutes till granulation completed) during granulation till appearance of granules the required consistent granules formed.
Record appearance of granules and LOD of wet mass after granulation completed.
Acceptance Criteria:RMG should be capable of producing desired granules.
Amperage reading should be increased as granulation time progresses.
Functioning of RMG should be in normal, safe and secure condition.
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S.S.NoNo
Material nameMaterial nameSpecifiSpecificationcation
Quantity Quantity specifispecifi
eded(in kg)(in kg)
Quantity Quantity dispensedispense
dd(in kg)(in kg)
A.R NoA.R No
Dispensed Dispensed by by
storesstoresSign&datSign&dat
ee
Checked Checked by by QAQA
Sign&daSign&datete
11 LactoseLactose
22 Ponceau 4 R supraPonceau 4 R supra
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Process parametersProcess parameters
Specification Specification Actual Actual observationobservation
Done by Done by ProductProduct
ionion
Checked by Checked by QAQA
Dry mixing Dry mixing
Mixing timeMixing time 20 minutes20 minutes
Impeller Speed Impeller Speed SlowSlow
Chopper Speed Chopper Speed --
Operational details:
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LOCATIOLOCATIONN
Colour content in %Colour content in %
After 5 minutesAfter 5 minutes After 10 minutesAfter 10 minutes After 15 minutesAfter 15 minutes After 20 minutesAfter 20 minutes
11
22
33
44
55
MeanMean
RSDRSD
Sample results:
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Process parametersProcess parametersSpecification Specification
Actual Actual observatioobservatio
nn
Done by Done by ProductiProducti
onon
Checked by Checked by QAQA
Dissolve HPMC in Dissolve HPMC in purified water purified water
Qty of water takenQty of water taken
Add extra quantity of Add extra quantity of water if required water if required ________kgs________kgs
--
Mixing timeMixing time Approx.15 minutesApprox.15 minutes
Impeller SlowImpeller Slow --
Chopper SlowChopper Slow --
Impeller fastImpeller fast --
Chopper fastChopper fast --
Granulation details:
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Granulation Time:
Appearance of granules:
LOD of wet granules:
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RSDRSD
MeanMean
Batch size: LowBatch size: Low
RSDRSD
MeanMean
Batch size: MediumBatch size: Medium
RSDRSD
MeanMean
Batch size: HighBatch size: High
After 20 minutesAfter 20 minutesAfter 15 minutesAfter 15 minutesAfter 10 minutesAfter 10 minutesAfter 5 minutesAfter 5 minutes
Colour content in %Colour content in %
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Granulation Granulation timetime
LOD of wet LOD of wet granulesgranules
Wet mixing