2. 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.
3. 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.
4. 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.
5. 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)
6. 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
12. 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
13. 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
14. Protocol Approval :
• Objective
• Critical Process control variables
• Test Program and Acceptance criteria
• Sampling points
• Qualification results
• Final Report
• Report Approval
15. 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.
16. CRITICAL PROCESS CONTROL VARIABLES:
Process control variables of dry mixing, wet mixing
operations and measured parameters are identified as
follows
SS..
NNoo OOppeerraattiioonn ssttaaggee CCoonnttrrooll vvaarriiaabblleess MMeeaassuurreedd ppaarraammeetteerrss
11 DDrryy MMiixxiinngg LLooaadd ssiizzee
MMiixxiinngg ttiimmee
CCoonntteenntt uunniiffoorrmmiittyy
22 WWeett MMiixxiinngg IImmppeelllleerr ssppeeeedd,, cchhooppppeerr ssppeeeedd
GGrraannuullaattiioonn ttiimmee
AAmmoouunntt ooff ggrraannuullaattiioonn fflluuiidd
WWaatteerr ccoonntteenntt//LLOODD
GGrraannuulleess aappppeeaarraannccee
AAmmppeerraaggee //ttoorrqquuee
Performance of Rapid Mixer Granulator shall be verified at different
control variables such as load size, and mixing time.
17. 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
18. 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.
19. Sampling points in rapid mixer granulator
1 2
4
3
5
1.Top Left
2.Top Right
3.Middle
4.Bottom Front
5.Bottom Rear
20. 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%
21. 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.
