GMP pharmaceutical clean room should have good production equipment, reasonable production processes, perfect quality management and strict testing systems to ensure that final product quality (including food safety and hygiene) meets regulatory requirements.
1. Minimize building area as much as possible
Workshops with cleanliness level requirements not only require a large investment, but also have high recurring costs such as water, electricity, and gas. Generally speaking, the higher the cleanliness level of a clean room, the greater the investment, energy consumption and cost. Therefore, on the premise of meeting the production process requirements, the construction area of the clean room should be reduced as much as possible.
2. Strictly control the flow of people and material
Pharmaceutical clean room should have dedicated flow for people and material. People should enter according to the prescribed purification procedures, and the number of people should be strictly controlled. In addition to the standardized management of purification of personnel entering and exiting pharmaceutical clean room, the entry and exit of raw materials and equipment must also go through purification procedures so as not to affect the cleanliness of the clean room.
3. Reasonable layout
(1) The equipment in clean room should be arranged as compactly as possible to reduce the area of the clean room.
(2) There are no windows in clean room or gaps between the windows and the clean room to close the outer corridor.
(3) The door of the clean room is required to be airtight, and airlocks are installed at the entrance and exit of people and objects.
(4) Clean rooms of the same level should be arranged together as much as possible.
(5) Clean rooms of different levels are arranged from low level to high level. Doors should be installed between adjacent rooms. The corresponding pressure difference should be designed according to the cleanliness level. Generally, it is about 10Pa. The opening direction of the door is towards the room with high cleanliness level.
(6) The clean room should maintain positive pressure. The spaces in clean room are connected in order according to the cleanliness level, and there is a corresponding pressure difference to prevent the air from the low-level clean room from flowing back to the high-level clean room. The net pressure difference between adjacent rooms with different air cleanliness levels should be greater than 10Pa, the net pressure difference between the clean room (area) and the outdoor atmosphere should be greater than 10Pa, and the door should be opened in the direction of the room with a high cleanliness level.
(7) Sterile area ultraviolet light is generally installed on the upper side of the sterile work area or at the entrance.
4. Keep the pipeline as dark as possible
In order to meet the requirements of workshop cleanliness level, various pipelines should be hidden as much as possible. The outer surface of exposed pipelines should be smooth, horizontal pipelines should be equipped with technical mezzanines or technical tunnels, and vertical pipelines crossing floors should be equipped with technical shafts.
5. Interior decoration should be conducive to cleaning
The walls, floors and top layers of the clean room should be smooth without cracks or accumulation of static electricity. The interfaces should be tight, without particles falling off, and be able to withstand cleaning and disinfection. The junctions between walls and floors, walls and walls, walls and ceilings should be made into arcs or other measures should be taken to reduce dust accumulation and facilitate cleaning.
Post time: Nov-08-2023