Some people may be familiar with GMP clean room, but most people still don't understand it. Some may not have a complete understanding even if they hear something, and sometimes there may be something and knowledge that are not know by particularly professional constructor. Because the division of GMP clean room needs to be scientifically divided based on these levels:
A: Reasonable control of clean room; B: meeting production process requirements;
C: Easy to manage and maintain; D: Public system division.
How many areas should GMP clean room be divided into?
1. Production Area and Clean Auxiliary Room
Including clean rooms for personnel, clean rooms for material, and some living rooms, etc. There are weeds, water storage, and urban garbage in the production area of GMP clean room. The ethylene oxide gas storage area is set next to the employee dormitory without relative protective measures, and the sample room is set next to the company canteen.
2. Administrative District and Management District
Including office, duty, management, and rest rooms, etc. Industrial factories and facilities should comply with manufacturing regulations, and the spatial layout of manufacturing, administrative departments, and auxiliary areas should be effective and not interfere with each other. The establishment of administrative departments and manufacturing areas will lead to mutual obstruction and unscientific layout.
3. Equipment Area and Storage Area
Including rooms for purification air conditioning systems, electrical rooms, rooms for high pure water and gas, rooms for cooling and heating equipment, etc. Here, it is necessary to consider not only the sufficient indoor space of the gmp clean room, but also the regulations for temperature and environmental humidity, and equipped with temperature and humidity adjustment equipment and monitoring instrument equipment. The storage and logistics area of GMP clean room should consider the storage standards and regulations for raw materials, packaging products, intermediate products, commodities, etc., and carry out division storage according to situations such as waiting for inspection, meeting standards, not meet standards, returns and exchanges, or recalls, which is conducive to the regular monitors inspection.
Generally speaking, these are just a few areas in GMP clean room division, and of course, there are also clean areas for controlling dust particle from personnel. Specific adjustments may need to be made based on actual situation.
Post time: May-21-2023