Rapid mixer graqnulator
Download as PPT, PDF76 likes33,205 views
The Rapid Mixer Granulator is a multi-purpose machine that can blend powders, granulate wet masses, and produce effervescent and melt pelletized products using mechanical agitation and shearing forces. Validation of the Rapid Mixer Granulator involves qualification of installation, operation, and performance to verify it can produce granules within specified parameters. Tests are conducted at different mixing speeds and times to ensure content uniformity and granule consistency meet acceptance criteria.
Rapid mixer graqnulator
- 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
- 8. Mixing Bowl
- 9. VALIDATION
- 10. Validation mainly includes: Installation qualification (IQ) Operational qualification (OQ) Performance qualification (PQ)
- 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.
- 22. SS.. NNoo MMaatteerriiaall nnaammee SSppeecciiffii ccaattiioonn QQuuaannttiittyy ssppeecciiffii eedd ((iinn kkgg)) QQuuaannttiittyy ddiissppeennssee dd ((iinn kkgg)) AA..RR NNoo DDiissppeennsseedd bbyy ssttoorreess SSiiggnn&&ddaatt ee CChheecckkeedd bbyy QQAA SSiiggnn&&ddaa ttee 11 LLaaccttoossee 22 PPoonncceeaauu 44 RR ssuupprraa
- 23. Operational details: PPrroocceessss ppaarraammeetteerrss SSppeecciiffiiccaattiioonn AAccttuuaall oobbsseerrvvaattiioonn DDoonnee bbyy PPrroodduucctt iioonn CChheecckkeedd bbyy QQAA DDrryy mmiixxiinngg MMiixxiinngg ttiimmee 2200 mmiinnuutteess IImmppeelllleerr SSppeeeedd SSllooww CChhooppppeerr SSppeeeedd --
- 24. Sample results: LLOOCCAATTIIOO NN CCoolloouurr ccoonntteenntt iinn %% AAfftteerr 55 mmiinnuutteess AAfftteerr 1100 mmiinnuutteess AAfftteerr 1155 mmiinnuutteess AAfftteerr 2200 mmiinnuutteess 11 22 33 44 55 MMeeaann RRSSDD
- 25. Granulation details: PPrroocceessss ppaarraammeetteerrss SSppeecciiffiiccaattiioonn AAccttuuaall oobbsseerrvvaattiioo nn DDoonnee bbyy PPrroodduuccttii oonn CChheecckkeedd bbyy QQAA DDiissssoollvvee HHPPMMCC iinn ppuurriiffiieedd wwaatteerr QQttyy ooff wwaatteerr ttaakkeenn AAdddd eexxttrraa qquuaannttiittyy ooff wwaatteerr iiff rreeqquuiirreedd ________________kkggss -- MMiixxiinngg ttiimmee AApppprrooxx..1155 mmiinnuutteess IImmppeelllleerr SSllooww -- CChhooppppeerr SSllooww -- IImmppeelllleerr ffaasstt -- CChhooppppeerr ffaasstt --
- 26. Granulation Time: Appearance of granules: LOD of wet granules:
- 27. BBaattcchh ssiizzee:: HHiigghh MMeeaann RRSSDD BBaattcchh ssiizzee:: MMeeddiiuumm MMeeaann RRSSDD BBaattcchh ssiizzee:: LLooww MMeeaann RRSSDD CCoolloouurr ccoonntteenntt iinn %% AAfftteerr 55 mmiinnuutteess AAfftteerr 1100 mmiinnuutteess AAfftteerr 1155 mmiinnuutteess AAfftteerr 2200 mmiinnuutteess
- 28. Wet mixing GGrraannuullaattiioonn ttiimmee LLOODD ooff wweett ggrraannuulleess