The Quality Inspection Center Laboratory of pharmaceutical factory is an integral part of the pharmaceutical project. It mainly tests and verifies the pharmaceutical production process, raw and auxiliary materials, packaging materials, semi-finished products and finished products, so as to ensure the quality of pharmaceuticals.
According to the current GMP and the relevant laboratory requirements of the laboratory quality management specification of Drug Inspection Institute (Trial), the purification design of the laboratory of the drug factory quality inspection center can be set according to the following aspects:
1、 Main purification function room of Quality Inspection Center Laboratory of pharmaceutical factory
1. Reagent and standard room;
2. Clean the washing area, such as cleaning room, disinfection room, preparation room and training room;
3. General analysis and experiment areas, such as chemical laboratory, raw and auxiliary materials laboratory, packaging materials laboratory, general instruments laboratory and finished products laboratory;
4. Data storage and data processing area, such as archives room and computer room;
5. Sample retention observation room, including accelerated stability inspection room;
6. Personnel rooms, such as changing rooms and rest rooms;
7. Special analysis area. It can be divided into physical and chemical system (such as high temperature room, precision instrument room, balance room, gas room, etc.) and biological system (such as antibiotic microorganism test room, sterility test room, microbial limit test room, etc.).
2、 Environment purification setting of main function room of laboratory purification in quality inspection center of pharmaceutical factory
The requirements for setting the environmental parameters of the quality inspection center of pharmaceutical plants are divided into three categories:
The first one is the requirement of air cleanliness between functions.
1. Aseptic examination room, microbial limit examination room and antibiotic microorganism examination room shall be set separately;
2. The sterility examination room and the micro cattle limit examination room shall be sterile clean room, the indoor purification level shall not be lower than 10000 level, and the operation area shall be equipped with local 100 level one-way flow device;
3. The purification level of antibiotics microbiological laboratory should be at least 100000.
The second is the requirement of temperature and humidity between functions;
1. For example, the environmental parameters of the accelerated stability inspection room are usually: temperature 40 ℃, humidity 75%; the balance room and precision instrument room are mainly required to be dehumidified.
The third type is common office area, etc. there is no special requirement. For example, special exhaust facilities are required in the gas room.
3、 Purification air purification system and auxiliary facilities of Quality Inspection Center Laboratory of pharmaceutical factory
1. Human net facilities
Confirm the level requirements of air cleanliness. The staff entering the clean area need to change clothes to prevent dust from entering. In order to avoid cross contamination, the personnel purification facilities of level 10000 sterile room, level 10000 non sterile room and level 100000 clean room should be set respectively. When entering different clean rooms, the corresponding clean clothes should be replaced.
2. Physical facilities
Material purification refers to the purification of raw and auxiliary materials, reagents, semi-finished products, packaging materials, etc. used in production and operation. The articles and material purification facilities entering the sterile room shall be treated and set according to the sterile requirements. Physical purification facilities include: transfer window (with UV sterilization), external cleaning room, disinfection room, buffer room, tool cleaning room and other related facilities.
Ed purification company is mainly engaged in purification system engineering projects and installation of supporting facilities, such as purification operating room and intensive care ICU, supply room, laboratory purification, electronic workshop, medicine, food hygiene air purification workshop, constant temperature and humidity engineering design, construction, after-sales service and product development. The company has established good cooperation with many domestic universities and international well-known companies Partnership. For more lab room cleanroom knowledge, please pay attention to WeChat public address: Aide-188 (Ed purified oxygen supply).