Pilot Plant Scale up Technique Ppt.pdf

The uploaded Power point presentation is of Industrial Pharmacy-II Unit-I (Topic - Pilot Plant Scale up Techniques). ppt is very useful for student of B.pharmacy

1. SUBJECT-INDUSTRIAL PHARMACY -II
SUBJECT CODE –BP702T
SEMESTER –VII (B.PHARM IV YEAR)
TOPIC –PILOT PLANT SCALE UP TECHNIQUE
PREPARED BY –MR. SATYENDRA KUMAR MISHRA
DESIGNATION –ASSOCIATE PROFESSOR
EMAIL –[email protected]
FACLTY OF PHARMACEUTICAL SCIENCES
RAMA UNIVERSITY, MANDHANA, KANPUR

3. Pilot Plant Scale Up

4. Why the Pilot Plant
Ineveryemergingpharmaceuticalindustryoranalready
existingone,thereisalwaysaneedtohaveanintermediate
batchscalerepresentingproceduresandsimulatingthat
usedforcommercialmanufacturing.
Thisisachievedbydeterminingtheabilityofformulato
withstandbatch-scaleandprocessmodification.
Research&DevelopmentPilotPlant Production

5. Why the Pilot Plant
Plant-:Itisaplacewherethe5M’slikemoney,material;man,
methodandmachinearebroughttogetherforthe
manufacturingoftheproducts.
PilotPlant-:Itisthepartofthepharmaceuticalindustrywhere
alabscaleformulaistransformedintoaviableproductby
developmentofliableandpracticalprocedureofmanufacture.
Scale-up-:Theartfordesigningofprototypeusingthedata
obtainedfromthepilotplantmodel.

6. Why conduct Pilot Plant Studies?
Apilotplantinvestigatesaproductandprocessonan
intermediatescalebeforelargeamountsofmoneyare
committedtofull-scaleproduction.
Itisusuallynotpossibletopredicttheeffectsofamany-
foldincreaseinscale.
Itisnotpossibletodesignalargecomplexfoodprocessing
plantfromlaboratorydataalonewithanydegreeof
success.

7. Application of Pilot Plant
Evaluatingtheresultsoflaboratorystudiesandmakingproduct
andprocesscorrectionsandimprovements.
Producingsmallquantitiesofproductforsensory,chemical,
microbiologicalevaluations,limitedmarkettestingor
furnishingsamplestopotentialcustomers,shelf-liveand
storagestabilitystudies.
Determiningpossiblesalableby-productsorwastestream
requiringtreatmentbeforedischarge.

8. Application of Pilot Plant
Providingdatathatcanbeusedinmakingadecisionon
whetherornottoproceedtoafullscaleproductionprocess;
andinthecaseofapositivedecision,designingand
constructingafull-sizeplantormodifyinganexistingplant.
Researchersusepilotscalebatchestodiscover
methodologiesthatwillbeusedtomakeconsiderably
biggerbatchesforclinicaltrialsand,ultimately,
manufactureapprovedproducts.

9. Objectives of Pilot Plant Scale-Up
Totrytheprocessonamodelofproposedplantbefore
committinglargesumofmoneyonaproductionunit.
Examinationoftheformulatodetermineitsabilityto
withstandBatch-scaleandprocessmodification.
EvaluationandValidationforprocessandequipments.
ToidentifythecriticalfeaturesoftheprocessGuidelines
forproductionandprocesscontrols.
Toprovidemastermanufacturingformulawithinstructions
formanufacturingprocedure.
Toavoidthescale-upproblems.

10. General Consideration of Pilot Plant
1.Personnel Requirements : Personnel should have –
Scientistswithexperienceinpilotplantoperationsaswellasin
actualproductionareatounderstandtheintentofthe
formulatoraswellasunderstandtheperspectiveofthe
productionpersonnel.
Thegroupshouldhavesomepersonnelwithengineering
knowledgeaswellasscaleupalsoinvolvesengineering
principles.

11. General Consideration of Pilot Plant
2. Space Requirements
(a)Administration and information process:
Adequateofficeanddeskspaceshouldbeprovidedfor
bothscientistandtechniciansandthespaceshouldbe
adjacenttotheworkingarea.

12. General Consideration of Pilot Plant
(b) Physical testing area:
Thisareashouldprovidepermanentbenchtopspacefor
routinelyusedphysical-testingequipment.

13. General Consideration of Pilot Plant
(c) Standard equipment floor space:
Discreetpilotplantspace,wheretheequipmentneededfor
manufacturingalltypesofdosageformislocated.
Intermediate–sizedandfullscaleproductionequipmentis
essentialinevaluatingtheeffectsofscale-upofresearch
formulationsandprocesses.
Equipmentsusedshouldbemadeportablewhereeverpossible
sothatafteruseitcanbestoredinthesmallstoreroom.
Spaceforcleaningoftheequipmentshouldbealsoprovided.

14. General Consideration of Pilot Plant

15. General Consideration of Pilot Plant
(d) Storage area:
Twoseparateareasforapprovedandunapprovedactive
ingredientaswellasexcipients.
Separateareasforthestorageofthein-processmaterials,
finishedbulkproductsfromthepilot-plant&materialsfrom
theexperimentalscale-upbatchesmadeintheproduction,
packingmaterial.

16. General Consideration of Pilot Plant
3. Review of the formula:
Athoroughreviewoftheeachaspectofformulation.
Thepurposeofeachingredientandit’scontributiontothefinal
productmanufacturedonthesmall-scalelaboratoryequipment.
Effectofscale-upusingequipmentthatmaysubjectthe
producttostressesofdifferenttypesanddegreescanmore
readilybepredicted,orrecognized.

17. General Consideration of Pilot Plant
4. Raw Materials:
Onepurpose/responsibilityofthepilot-plantistheapproval&
validationoftheactiveingredient&excipientsrawmaterials.
Rawmaterialsusedinthesmallscaleproductioncannot
necessarilybetherepresentativeforthelargescaleproduction.

18. General Consideration of Pilot Plant
5. Relevant Processing Equipment:
Themosteconomicalandthesimplest&efficientequipment
whicharecapableofproducingproductwithintheproposed
specificationsareused.
Thesizeoftheequipmentshouldbesuchthattheexperimental
trialsrunshouldberelevanttotheproductionsizedbatches.
Iftheequipmentistoosmalltheprocessdevelopedwillnot
scaleup,Whereasifequipmentistoobigthenthewastageofthe
expensiveactiveingredients.

19. General Consideration of Pilot Plant
6. Production Rates:
Itcanbedeterminedbytheimmediatefuturemarket
requirements.
Equipmentandtheprocessshouldbechosenonthebasisof
productionofabatchatafrequencythattakesintoconsideration
:
✓Productlossintheequipmentduringmanufacture.
✓Thetimerequiredtocleantheequipmentbetweenbatches.
✓Thenumberofbatchesthatwillneedtobetestedforrelease.

20. General Consideration of Pilot Plant
7. Process Evaluation:
Itisthebasisofprocessvalidation.
Documentationofprocessistobedone.
Processisvalidatedonlyiftherearenochangesinthe
formula,qualityoftheingredients,ortheequipment
configuration.
Revalidationneedstobedonetoensurethatchangeshave
nottakeplace.

21. General Consideration of Pilot Plant

22. General Consideration of Pilot Plant
8. Product stability and uniformity:
Theprimaryobjectiveofthepilotplantisthephysicalas
wellaschemicalstabilityoftheproducts
Henceeachpilotbatchrepresentingthefinalformulation
andmanufacturingprocedureshouldbestudiedfor
stability.
Stabilitystudiesshouldbecarriedoutinfinishedpackages
aswell.

23. General Consideration of Pilot Plant
10. GMP considerations:
GMP items that should be a part of scale up are –
✓Equipment qualification.
✓Process validation.
✓Regularly schedule preventative maintenance.
✓Regularly process review & revalidation.
✓Relevant written standard operating procedures.
✓The use of competent technically qualified personnel.
✓Adequate provision for training of personnel.
✓A well-defined technology transfer system.
✓Validated cleaning procedures.

24. General Consideration of Pilot Plant
11. Transfer of Analytic methods to Quality Assurance:
Duringscaleuptheanalyticaltestmethodsdevelopedin
researchshouldbetransferredtotheQAdepartment.
QAstafftoreviewprocesstomakesureproperanalytic
equipmentsareavailableandpersonnelaretrained.
Theyshouldreviewtheassayproceduresandthethat
obtainedduringvalidationstudiestoverifythatthethere
arenochangesintheanalyticalprocedure.

25. Thank you