What are GMP pharmaceutical factory clean workshops and management requirements?

Popular Science on Disinfection Services |: What is a GMP pharmaceutical factory clean workshop? Some people are curious about where the medicine we take is produced. What are the special requirements for such a workshop design? Shanghai Fantong Biological Disinfection Service would like to share with you the design features of the clean workshop of a pharmaceutical factory. (1) Clean room or clean area of ??a pharmaceutical factory

A clean room or clean area of ??a pharmaceutical factory refers to an area where dust particles and microbial contamination need to be controlled. According to GMP design requirements, pharmaceutical factory production areas are usually divided into general production areas (no cleanliness requirements), control areas (level 100,000, 300,000), clean areas (level 10,000) and sterile areas (level 100). Drugs are used to treat illnesses and save lives. To ensure the quality and safety of drugs, GMP stipulates that preparation production, raw material drying bags, raw and auxiliary materials used in preparations, packaging materials in direct contact with drugs, etc., should all be carried out in clean areas. Therefore, the so-called clean workshop must first basically eliminate harmful gases, bacteria, microorganisms, particulate pollutants, etc. in the workshop. Secondly, environmental factors (indicators) such as temperature, pressure, noise, and light in the workshop should also be within a reasonable range.

(2) What requirements should the clean area of ??the clean workshop of a pharmaceutical factory meet?

The clean area uses a large air-conditioning system and air filtration facilities to enable a relatively closed environment to meet the required cleanliness requirements, forming the "clean area" we need.

1) Temperature and humidity: It should meet the temperature and humidity requirements of the varieties produced.

2) The inner surface of the clean area: The inner surface of the clean area (walls, floors, ceilings) should be flat, smooth, without cracks, tight joints, and without particles falling off to avoid dust accumulation and facilitate effective cleaning. Disinfection services should be carried out when necessary.

3) Cleanliness: The clean area of ??a pharmaceutical factory is divided into ABCD, mainly the number of particles and microorganisms in the air, which must meet the cleanliness requirements specified at this level.

4) Persons entering the clean area must change shoes, change clothes, wash hands, and disinfect hands as required before entering the clean area.

(3) Disinfection services in the clean workshops of pharmaceutical factories

Disinfection services are a key link in the clean workshops of pharmaceutical factories to ensure the production quality of enterprises. Vaporized hydrogen peroxide (VHP) decomposes into oxygen and water after disinfection and has no residual toxicity. It is recognized as an efficient and environmentally friendly disinfection service method. The vaporized hydrogen peroxide disinfection robot kino developed by Shanghai Fantong Biological Disinfection Service is easy to carry and It is simple to operate and can start disinfection with one click. It can be used for disinfection in pharmaceutical factories quickly, efficiently and flexibly. It has no dead ends, no residue, and saves human resources. It is a brand-new disinfection and sterilization equipment.

?The disinfection robot kino can complete air and equipment surface disinfection services in one go. During the disinfection process, it has strong effects on various bacteria (including Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus), fungi, and viruses. It has a very good killing effect on spores and molds, achieving a proven 6-log spore killing rate. The disinfection residue is degraded to generate water and oxygen, leaving no residue and pollution, no corrosion to equipment and facilities, and good material compatibility. Shanghai Fantong Biological Disinfection Service has been engaged in pharmaceutical factory disinfection services for decades and is familiar with microbial pollution control solutions. High-tech disinfection robot equipment combined with air-conditioning duct system disinfection can be used for pathogen disinfection services in the closed environment of GMP workshops to rebuild a clean and sterile environment. Effect.