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GOOD MANUFACTURING PRACTICES (GMP) REQUIREMENTS FOR STERILE PRODUCTS

  1. Specific Points Relating to Minimizing Risks of Contamination:
    1. Microbiological
    2. Particulate matter
    3. Pyrogen
  2. Clean Room:
    1. The room should undergo 15–20 air exchanges per hour.
    2. HEPA filters are installed to clean the air entering the room. They are used to remove all airborne particles of size 0.3 microns or larger with an efficiency of 99.97%.
    3. To minimize the infiltration of airborne contaminants from outside, higher air pressure (positive pressure) within the critical area should be maintained.
    4. Care should be taken to ensure that airflows do not distribute particles, people, operation process or equipment to a zone of higher product risk. A warning system should be provided to indicate failure in the air supply.
    5. Adjacent rooms of different grades should have a pressure differential of 10–15 Pascals.
    6. Counters in the clean room should be made of stainless steel or any other nonporous material, which can be easily cleaned.
    7. Walls and floors should be free from cracks or crevices and should have tapering corners. The walls, ceiling and floors should be epoxy painted.
    8. The airflow should move with uniform velocity along parallel lines. The velocity of the airflow should be maintained at 90 ± 20 ft/m3.
    9. Controlled temperature and humidity conditions are to be maintained.
  3. Airlocks for Entry:
    1. Personnel entry
    2. Material entry
  4. Separate Areas for Operations:
    1. Component preparation
    2. Product preparation
    3. Filling and sealing
  5. Air Classification—Grades A, B, C and D: The air system shall be provided with the appropriate filters such as HEPA for grades A, B and C. The maximum number of particles permitted “at rest” condition shall approximately be as follows:
    1. Grade A corresponds with class 100, M 3.5, or ISO class 5.
    2. Grade B corresponds with class 1000, M 4.5, or ISO class 6.
    3. Grade C corresponds with class 10,000, M 5.5, or ISO class 7.
    4. Grade D corresponds with class 100,000, M 6.5, or ISO class 8.The requirement and limit for the area shall depend on the nature of the operation carried out. The types of operations to be carried out in the various grades are given in Table 8.2. Table 8.2 Types of Operations to be Carried Out in the Various Grades for Aseptic PreparationsGradeTypes of Operations for Aseptic PreparationsAAseptic preparation and fillingBBackground room conditions for activities requiring grade ACPreparation of solution to be filteredDHandling of components after washing
  6. Laminar Airflow Hood:
    1. These are clean air workbenches specially designed to ensure the aseptic preparation of sterile products. Laminar airflow hoods are generally used in combination with clean rooms.
    2. The airflow rates would be 0.3 m/sec (vertical) and 0.45 m/sec (horizontal)
    3. Laminar airflow velocity satisfactorily sweeps the area but does not create unacceptable turbulence.

Tayyaba Bukhari

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