This module aims to provide the student with the knowledge to understand and maintain clean room environments.
Clean-rooms
Clean-room classifications and standards. Types of clean-rooms, their location within buildings and their various applications in the pharmaceutical industry. Analysis of the fundamentals of air filtration: principles of HEPA filtration and design of HEPA systems and ventilators. Systems of air classification: Federal Standard 209. B.S. 5295. ISO standards etc.
Materials and Equipment for Clean-rooms
Selection of walls, ceilings, floor material and equipment. Barrier/Isolator technology. Air showers, weighing cabinets and material pass-through corridors.
Clean-room Practices
Clothing and housekeeping practices for the clean room staff and maintenance contractors. Critical control of clean-room entrance practices. Standard Operating Procedures for clean-room work.
Clean-room test Equipment and Monitoring
Monitoring the quality of materials entering the clean-room. Monitoring air and surface quality in clean-rooms. Monitoring decontamination procedures used in clean-rooms. Clean-room standards for designating normal, alert and alarm levels.
Cleaning, Decontamination and Segregation of Working Areas within Clean-rooms
Introduction to specialized methods of cleaning and decontaminating clean-rooms. Introduction to positive air pressure environments and their use in segregating working areas within clean-rooms. Review of personal behaviour in clean rooms and how this influences clean-room contamination.
Contamination
The nature of contamination; physical, chemical and biological residues. Examination of sources of residues and how residues are transported within the work environment. Problems caused by the presences of contaminating residues in pharmaceutical processes. Materials/equipment compatibility and contamination of pharmaceuticals.
Cleaning equipment and Reagents
Selection of cleaning agents and items of equipment in use in the pharmaceutical manufacturing sector. Criteria used in the selection of appropriate cleaning agents and equipment.
Controlled Cleaning
Principles of effective cleaning. Understanding the chemistry of cleaning. Writing standard operating procedures describing controlled cleaning practices. Disinfectant effectiveness testing, testing the effectiveness of cleaning agents. Practical monitoring the effectiveness of cleaning regimes. And disinfectants. Cleaning validation made simple.
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 40 |
| Formal Examination | 60 |