JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

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

On completion of this course it is expected that students will be able to;

• Manage the scale up process in pharmaceutical industry.
• Assist in technology transfer.
• To establish safety guidelines, which prevent industrial hazards

UNIT - I

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

UNIT - II

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

UNIT - III

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.

UNIT - IV

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

UNIT - V

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. M.PharmII Year I Sem (Industrial Pharmacy)