(1) Strictly control passenger flow and logistics.

   The GMP drug purification workshop should have a dedicated flow, flow channel. Personnel purification procedures should be required to enter, and the number should be strictly controlled. In addition to the standardized management of personnel visits in pharmaceutical purification plants, raw materials and equipment must also be cleaned out in the process, which will not affect the cleanliness of the clean side room.

   (2) Strengthen personnel management

   In the clean room, people are the biggest source of pollution, and people are an important factor in determining the generation of particle pollutants. Therefore, before entering the purification area of the pharmaceutical factory workshop, you must follow the beneficiation procedures and wear clean and dust-free clothes and gloves that meet the corresponding cleanliness level. , It is necessary to repeatedly train the clean room staff to improve the cleaning awareness of the clean room staff.

   (3) Separation of air conditioning purification system

   The air-conditioning purification system of the GMP pharmaceutical factory workshop should be divided according to different cleanliness levels. For clean rooms such as hormones, virulent microorganisms, antineoplastic drugs, and radiopharmaceuticals, high-efficiency filtration equipment should be installed at the vents to minimize the contamination of these drugs. A separate local exhaust system should be set up in the clean room where dust and harmful gases are generated. The opening and closing of air supply, return air and exhaust air shall be interlocked.

   (4) The area of reasonable allocation of space

   Reasonable space and area are conducive to reasonable zoning, operation and maintenance of various public facilities, such as pipes, vents, lighting facilities, etc., and parts that are not easy to clean should be avoided. The layout should be based on product characteristics, room pressure difference, equipment conditions, etc. Reasonable.

   (5) Improve equipment level

   The materials, processing accuracy, sealing degree and management system of the purification equipment in the gmp factory workshop are all related to cross-contamination. Therefore, improving the automation level of equipment to reduce the number of operators is a necessary measure to prevent cross-contamination.

Suzhou Pharma Machinery Co.,Ltd.

2023/03/01

Birkey