SCALE UP AND TECHNOLOGY TRANSFER (M. Pharm, Industrial Pharmacy, CUTM2007) (4-0-0)
Teacher
Yashwant Giri
Category
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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 1
Pilot plant design:
https://www.pharmaguideline.com/2021/07/pilot-plant-scale-up-considerations.html
Session 4
Scale up: Importance, Technology transfer from R & D to pilot plant to plant scale.
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 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.
Session 17
Importance, IQ, OQ, PQ for equipments – liquid filling and sealing machine. Aseptic room validation.Unit-3, M.Pharm
Session 19
Process validation:https://www.researchgate.net/publication/266209667_Industrial_Process_Validation_Of_Solid_Dosage_Forms_-_An_Overview
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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