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WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 14): Sterile Pharmaceutical Products
(62 pages)

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Sterile Production

Premises (continued)

  • Changing rooms

    - designed as airlocks

    - effective flushing with filtered air

    - separate rooms for entry and exit desirable

    - hand washing facilities

    - interlocking system for doors

    - visual and/or audible warning system

  • Use filtered air supply to maintain pressure cascade

  • Pressure differential approximately 10 to 15 Pascals

  • Zone of greatest risk - immediate environment

Entry to all processing areas should be through airlocks. For personnel, these airlocks generally take the form of changing rooms that have a variable number of interconnecting rooms, depending on the grade of the area. Ideally, separate airlocks should ideally be provided for the entry of materials into the area. Airlocks should be flushed with filtered air. In some facilities, there are different airlocks for entry to and exit from manufacturing areas. This can promote unidirectional flow of personnel and material. Hand washing facilities should only be provided in change rooms, and not in production areas.

Filtered air should be supplied to the areas and in such a manner, that the pressure cascade is maintained. There should normally be a pressure differential of 10 to 15 Pascal between areas of lower and higher risk.

The supply of suitable quality air to sterile manufacturing areas, is very important. Filtered air under positive pressure should be supplied to production areas of sterile products. Verify whether the manufacturer has validation data of aspects relating to airflow patterns, and warning systems indicating failure of air supply (e.g. manometers measuring pressure differentials, or an audible alarm).Check the configuration and maintenance of HVAC and filters.

The pressure differentials between areas should be monitored and recorded in accordance with written SOPs.

(Note: Trainers should explain with the aid of a flip chart and drawings, suitable layout of premises, indicating air supply and return to areas, desired air flow patterns, design and purpose of air locks, and the concept of pressure differentials between different areas).

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Dernière mise à jour: le 4 mai 2012