PHRM06004 2019 Contamination Control and Clean Room Management

Identify the common sources of contaminants.

Apply the fundamental steps of aseptic practice.

Use a wide range of cleaning agents and know when to apply them.

Define and apply the basis of cleaning validation.

Work in a clean-room environment.

Describe the basis of clean-room operation.

Monitor the clean-room environment.

Decontaminate the clean-room.

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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.

Housekeeping and Contamination Control

Review of good housekeeping practices, procedures and barrier technology used in the control of contamination in pharmaceutical manufacturing facilities.  Analysis of facility design and its influence on the spread of contaminants.