Introduction to the types of GMP purification workshops in biopharmaceutical companies
1. Turbulent flow
The air enters the GMP purification workshop from the air conditioning box through the air duct and the air filter in the clean room, and returns to the GMP purification workshop on both sides of the partition wall panels or raised floors. The airflow is in a non-linear motion but in an irregular turbulent or vortex state. This type is suitable for GMP purification workshop level 1,000-100,000.
Advantages: simple structure, low system construction cost, easy to expand the clean room, and in some special purpose places, dust-free workbench can be used together to improve the clean room level.
Disadvantages: The fine dust particles caused by turbulent flow float in the indoor space and are not easy to be discharged, and are easy to pollute the process products. In addition, if the system is shut down and then activated, it often takes a long time to achieve the required cleanliness.
2. Laminar flow
The laminar air flow moves into a uniform straight line, the air enters the room through the filter with a coverage rate of 100%, and returns to the room through the raised floor or the partition boards on both sides. This type is suitable for the environment where the GMP purification workshop level needs to be set higher. Generally, the clean room level is Class 1~100. Its type can be divided into two types:
(1) Horizontal laminar flow
The horizontal air is blown out from the filter in one direction, and returned by the return air system on the opposite wall, and the dust is discharged out of the GMP purification workshop along with the wind direction, and the pollution is generally serious on the downstream side.
Advantages: The structure is simple, and it can become stable in a short time after operation.
Disadvantages: The construction cost is higher than that of the turbulent flow type, and the indoor space is not easy to expand.
(2) vertical laminar flow
The ceiling of the GMP purification workshop room is completely covered with ULPA filters, and the air is blown from top to bottom to obtain a high degree of cleanliness. The dust generated during the process or by the staff can be quickly discharged outside without affecting other working areas.
Advantages: easy management, a stable state can be reached within a short time after the start of operation, and it is not easily affected by the operating state or operating personnel.
Disadvantages: high construction cost, difficult to use space flexibly, ceiling hangers take up a lot of space, maintenance and replacement of filters is troublesome.
