JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

Course Objectives

The student shall learn about Industrial area design, Current good

manufacturing practices. They also learn about packaging components, polymers and metals used in packaging. They also understand about the storage conditions of different formulations and their stability evaluations.

Course Outcome

At the end of the semester student will get an idea about Industrial area design

and packaging of different formulations and its stability conditions.

UNIT - I

Production Area Design: Selection of plant location, Design of plant for bulk drugs and formulations(Solids, Semisolids, Injectables, Nutraceuticals etc), General utilities such as purified water, portable water, water for injection, Air handling units-Relative humidity and Temperature control, Material and personnel movement. Warehouse handling-API, Excipients, packaging materials and solvents.

UNIT - II

Current Good Manufacturing Practices: GMP design for buildings & facilities. GMP layout design. Clean room classifications. Segregation & cross contamination control. HVAC (heating, ventilation & air-conditioning) systems. Clean room environment control. Documentation and record keeping: Specifications and testing procedures, Specifications for finished products, Master Formulae, Packaging instructions. Batch processing records, Standard operating procedures.

UNIT - III

Pharmaceutical packaging and Design: Introduction, Packaging system, Components of packaging, Symbols used on packages and labels. Package development and Design research. Packaging materials- Polymers and Plasters, Glass, Metal and Blister and strip packaging.

UNIT - IV

Stability of Packaging: Introduction, Legislation, Regulation, Pharmaceutical Stability Testing in Climatic Cabinets, Pharmaceutical Stability Testing Conditions, Photo-Stability Testing, Review of Pharmaceutical Product Stability, Packaging and the ICH Guidelines.

UNIT - V

Packaging of Solids, Semisolids, Parenterals, Ophthalmic and Aerosols: Introduction, Packaging of Solid and semisolids, Packaging of Sterile Pharmaceuticals, Packaging Components, Inspection of Filled Injectable Products, Storage and Labelling, Packaging of Ophthalmics, Selection of Packaging Materials, Packaging of Aerosols.

REFERENCE BOOKS:

• 1. Leon Lachman; Lieberman Herbert A.; Kanig, Joseph L. The theory and Practice of Industrial Pharmacy.
• 2. Gilbert Banker and Christopher Rhodes. Modern Pharmaceutics.
• 3. Aulton’s Pharmaceutics: The design and Manufacture of Medicine
• 4. D. A. Dean, Roy Evans, Ian Hall. Pharmaceutical packaging technology. Tylor and Francis.
• 5. Edward J. Bauer, Pharmaceutical Packaging Handbook. Bausch and Lomb, Rochester, New York, USA.
• 6. Pharmaceutical Facilities: Design, Layouts and Validation, Potdar, Pharmamed Press
• 7. Wilmer A. Jenkins, Kenton R. Osborn. Packaging drugs and pharmaceuticals.
• 8. Remington: The Science and Practice of Pharmacy. 8. Michael E. Aulton, Kevin Tylor
• 9. Pharmaceutical Packaging Technology, UK jain, Pharmamed Press M.Pharm II Year I Sem (Pharmaceutical Chemistry)