SCALE UP AND TECHNOLOGY TRANSFER (M. Pharm, Industrial Pharmacy, CUTM2007) (4-0-0)

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Yashwant Giri

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Subject: SCALE UP AND TECHNOLOGY TRANSFER

Subject code (credit): CUTM2007 (4-0-0)

Course Objectives

This course is designed to impart knowledge and skills necessary to train the students to be on scale up, technology transfer process and industrial safety issues.

Course Outcomes

CO OUTCOMES PO MAPPING
CO1 Understand pilot plant design and lay-out. PO1, PO2, PO3
CO2 Understand various steps of technology transfer. PO6, PO8, PO9, PO10,

PO11

CO3 Know the general concepts, types, procedures & protocols, documentation in validation. PO3,PO4, PO9
CO4 Demonstrate importance of Design qualification, Installation qualification, Operational qualification, Performance qualification. PO2,PO3
CO5 Appreciate Industrial safety. PO5, PO7, PO8, PO11

Syllabus

Module 01

Pilot plant design: Basic requirements for design, facility, equipment selection, for tablets, capsules, liquid orals, parentral and semisolid preparations.

Scale up: Importance, Technology transfer from R & D to pilot plant to plant scale, process scale up for tablets, capsules, liquid orals, semisolids, parentral, NDDS products – stress on formula, equipments, product uniformity, stability, raw materials, physical layout, input, in-process and finished product specifications, problems encountered during transfer of technology.

Module 02

Validation: General concepts, types, procedures & protocols, documentation, VMF. Analytical method validation, cleaning validation and vender qualification.

Module 03

Equipment Qualification: Importance, IQ, OQ, PQ for equipments – autoclave, DHS, membrane filter, rapid mixer granulator, cone blender, FBD, tablet compression machine, liquid filling and sealing machine. Aseptic room validation.

Module 04

Process validation: Importance, validation of mixing, granulation, drying, compression, tablet coating, liquid filling and sealing, sterilization, water process systems, environmental control.

Module 05

Industrial safety: Hazards – fire, mechanical, electrical, chemical and pharmaceutical, Monitoring & prevention systems, industrial effluent testing & treatment. Control of environmental pollution.

References

1. Pharmaceutical process validation, JR Berry, Nash, Vol 57, Marcel Dekker, NY.

2. Pharmaceutical Production facilities, design and applications, by GC Cole, Taylor and Francis.

3. Pharmaceutical project management, T.Kennedy, Vol 86, Marcel Dekker, NY.

4. The theory & Practice of Industrial Pharmacy, L.Lachman, H.A.Lieberman, Varghese Publ. Bombay.

5. Tablet machine instruments in pharmaceuticals, PR Watt, John Wiloy.

6. Pharmaceutical dosage forms, Tablets, Vol 1, 2, 3 by Lachman,
Lieberman, Marcel Dekker, NY.

7. Pharmaceutical dosage forms, Parentral medications, Vol 1, 2 by K.E. Avis, Marcel Dekker, NY.

8. Dispersed system Vol 1, 2, 3 by Lachman, Lieberman, Marcel Dekker, NY.

9. Subrahmanyam, CVS, Pharmaceutical production and Management, 2007,Vallabh Prakashan, Dehli.

 

Session 2

Equipment selection, for tablets, capsules, liquid orals.

Unit-1, M. Pharm

Session 3

Parentral and semisolid preparations.

Unit-1, M. Pharm

Session 4

Scale up: Importance, Technology transfer from R & D to pilot plant to plant scale.

Unit-1, M. Pharm

Session 5

Process scale up for tablets, capsules.

Unit-1, M. Pharm

Session 6

Process scale up for liquid orals, semisolids, parentral products.

Unit-1, M. Pharm

Session 7

Stress on formula, equipments, product uniformity, stability. Unit-1, M. Pharm

Session 8

Physical layout, Raw materials, input, in-process and finished product specifications. Unit-1, M. Pharm

Session 9

Problems encountered during transfer of technology.Unit-1, M. Pharm

Session 10

Validation:

Session 11

Types, procedures & protocols. Unit 2, M. Pharm

Session 12

Documentation, VMF. Unit 2, M. Pharm

Session 13

Analytical method validation, cleaning validation, Vender qualification. Unit 2, M. Pharm

Session 14

Equipment Qualification:

https://www.jgtps.com/admin/uploads/1fwM9K.pdf

Session 15

IQ, OQ, PQ for equipments – DHS, autoclave. Unit-3, M.Pharm

Session 16

Importance, IQ, OQ, PQ for equipments:  membrane filter, rapid mixer granulator, cone blender.

Unit-3, M.Pharm

Session 17

Importance, IQ, OQ, PQ for equipments –  liquid filling and sealing machine. Aseptic room validation.Unit-3, M.Pharm

Session 18

IQ, OQ, PQ for equipments: FBD, tablet compression machine.

Unit-3, M.Pharm

Session 20

Process validation: Importance, validation of mixing, granulation.Unit-4, M.Pharm

Session 21

Process validation:  drying, compression. Unit-4, M.Pharm

Session 22

Process validation: Tablet coating, liquid filling and sealing.Unit-4, M.Pharm

Session 23

Sterilization, water process systems, environmental control.Unit-4, M.Pharm

Session 24

Industrial safety:

https://www.slideshare.net/mallikarjunvasm/industrial-hazards-and-prevention-systems

Session 25

Industrial safety: Hazards – fire, mechanical.Unit-5, M.Pharm

Session 26

Electrical, chemical and pharmaceutical. Unit-5, M.Pharm

Session 27

Monitoring & prevention systems.Unit-5, M.Pharm

Session 28

Sources of pollution.Unit-5, M.Pharm

Session 29

Types of pollution. Unit-5, M.Pharm

Session 30

Method of control of environmental pollution. Unit-5, M.Pharm

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Yashwant Giri

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