Design and construction of GMP pharmaceutical clean workshop

  Requirements for medical clean room:
The temperature and humidity design parameters of the pharmaceutical clean room shall comply with the following provisions:
  1
When the drug production process and products have special requirements for temperature and humidity, it shall be determined according to the process and product requirements;
  2 when there are no special requirements for temperature and humidity in the pharmaceutical production process and products, the temperature of pharmaceutical clean rooms with air cleanliness of class A, class B and class C shall be 20 ℃ ~ 24 ℃ and the relative humidity shall be 45% ~ 60%; The temperature of medical clean room with air cleanliness grade D shall be 18 ℃ ~ 26 ℃ and the relative humidity shall be 45% ~ 65%;
  The temperature of the purification room in summer should be 26 ℃ ~ 30 ℃, and the temperature of the purification room in winter should be 16 ℃ ~ 30 ℃

The static pressure difference between medical clean rooms with different air cleanliness levels and between clean rooms and non clean rooms shall not be less than 10Pa, and the static pressure difference between medical clean rooms and outdoor atmosphere shall not be less than 10Pa

The layout of pharmaceutical clean room shall comply with the following provisions;
  1 on the premise of meeting the production process and noise requirements, the medical clean room with high air cleanliness level should be arranged close to the air conditioner room, and the processes with the same air cleanliness level and the layout of medical clean room should be relatively concentrated;
  2
Measures to prevent pollution shall be taken for personnel access and material transmission between medical clean rooms with different air cleanliness levels

An air lock or transfer cabinet shall be set between the material cleaning room or sterilization room and the medical cleaning room

The air filter shall be reasonably selected according to the requirements of air cleanliness level for the air purification treatment of medical clean room

The design of purified air conditioning system should make rational use of return air
However, the air in the following production places shall not be recycled:
  1
For the process of emitting dust in the production process, when the air cannot be avoided from cross slot dyeing after treatment;
  2
Processes that produce harmful substances, peculiar smell, a large amount of hot and humid or volatile gases in the production process

The opening and closing of supply air, return air and exhaust air shall be interlocked

The purified air conditioning system in the clean area of sterile drug production shall maintain continuous operation and maintain the corresponding cleanliness level

The unidirectional flow device with cleanliness level of class a area shall meet the following requirements:
  1
It shall cover the exposure process of sterile drug production and all areas specified in Appendix A of this specification

  2 when the area of one-way flow device is large and indoor circulating air is used for operation, measures shall be taken to reduce the temperature difference between the air cleanliness class a area and the indoor surrounding environment
The temperature in the air cleanliness class a area shall not exceed the indoor design temperature by 2 ℃ and 24 ℃

  3 the unidirectional flow device with class a air cleanliness shall use the lower part of the side wall or the ground grid for air return

  4 enclosure should be set at the outer edge of unidirectional flow device with local air cleanliness of class A, and the enclosure height should be lower than the operating surface

  5 when the unidirectional flow device adopts the combination of fan filter unit or laminar flow hood, the air supply volume shall be adjustable
The superimposed noise of the final resistance shall comply with the provisions of article 3
2
7 of this standard

  6 the one-way flow device shall be set to facilitate installation, maintenance and replacement of air filter

For the purified air conditioning system with multiple sets of air handling units centrally arranged and operating at the same time, the centralized treatment of fresh air should be adopted, and measures should be set to avoid mutual interference and influence of fresh air volume of each air conditioning system during operation

For the purified air conditioning system serving the core area of aseptic production, the steam source for air treatment and humidification should be the pure steam prepared by purified water