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What are the clean room isolation techniques in pharmaceutical factories

Industrial modular Clean Room time:2022/07/12 17:22:47 click:159

Through the long-term practice of femtosecond detection, the following measures can be implemented:

What are the clean room isolation techniques in pharmaceutical factories

(1) Strengthen personnel management

In clean room, human is the biggest pollution source, and human is an important factor to determine the generation of particulate pollutants. The proportion of particulate source in clean room is 7% infiltration in air, 8% brought in raw materials, 25% produced in equipment transfer, 25% produced in production process and 35% caused by human factors. Therefore, dress procedures must be followed before entering the clean room. Wear AClean and dust-free suit and AClean clean nitrile gloves that conform to the appropriate cleanliness level. At the same time, repeated training must be given to clean room workers to improve their awareness of cleanliness.

(2) Strictly control the flow of people and logistics

Clean room should be set up a dedicated stream of people, logistics channels. Personnel shall be admitted according to the prescribed purification procedure and the number of personnel shall be strictly controlled. In addition to the standard management of personnel in and out of the clean room +, raw materials and equipment in and out must also go through the clean procedure, so as not to affect the cleanliness of the clean room.

(3) Reasonable layout of space area

Reasonable space and area, conducive to reasonable partition, but also conducive to operation and maintenance. Clean room is not the bigger the better, the size of area and space is related to the size of air conditioning energy consumption and engineering investment. Reasonable production space is conducive to management, reduce environmental cleaning and disinfection work, but also conducive to energy conservation. At the same time, there should be intermediate stations for materials within the workshop to facilitate clear zoning to minimize errors and cross-contamination. All kinds of pipes, tuyere, lighting facilities and other public facilities should avoid difficult to clean parts. Should be based on product characteristics, room pressure difference, equipment and other reasonable layout.

(4) Improve the equipment level

The material, processing accuracy, airtight degree and management system of clean room equipment are all related to cross contamination. Therefore, it is necessary to improve the automation level of equipment to reduce the number of operators to prevent cross-contamination. New GMP requirements for aseptic isolation techniques. Aseptic isolation systems are fully sealed to control and process drugs and biological products into a sterile state. The isolation operation technology can prevent the product from being contaminated to the maximum extent, protect the operator's safety, and avoid being harmed by toxic substances.

(5) Separate air conditioning purification system

Clean room air conditioning purification system should be divided according to different cleanliness levels, for hormones, strong toxic microorganisms and anti-tumor drugs, radioactive drugs and other clean rooms, high efficiency filtration equipment should be installed in the exhaust vent, in order to reduce the pollution of these drugs to a minimum. Clean rooms that produce dust and harmful gases should have separate local exhaust systems. The opening and closing of air supply, return and exhaust should be interlocked.

Pollution control is throughout the entire drug production activities, clean room pollution control is also specific to implement in all aspects. Clean room pollution can be controlled from reasonable layout of space area, improvement of equipment level, separation of air conditioning purification system, strict control of people flow and logistics, strengthening personnel management and other aspects.