The construction of GMP (Good Manufacturing Practice) pharmacy clean rooms is a key link in ensuring the quality and safety of drugs. In order to meet GMP requirements, the construction of clean rooms needs to follow the following specific requirements:
1. Site selection and layout
Site selection: Clean rooms should be away from pollution sources, such as traffic arteries, boiler rooms, garbage stations, etc. At the same time, areas with higher terrain, fresh air and good ventilation should be selected.
Layout:
Clean areas and non-clean areas should be strictly separated, and facilities such as buffer rooms and transfer windows should be set up to prevent cross contamination.
People and logistics channels should be set up separately to avoid crossing.
The clean room should reasonably layout various functional rooms, such as dressing rooms, buffer rooms, operation rooms, temporary material storage rooms, etc., and ensure smooth process flow.
2. Building structure and decoration
Building structure: Clean rooms should be built with materials that are not easy to generate dust, not easy to accumulate dust, corrosion-resistant, and easy to clean, such as color steel plates, stainless steel, etc.
Decoration:
The walls, floors and ceilings should be smooth, without cracks or peeling. The corners should be rounded to facilitate cleaning and disinfection.
Doors and windows should be well sealed to prevent external pollutants from entering.
Lighting should use embedded clean lamps to avoid dust accumulation.
3. Air purification system
Purification level: According to the different requirements of drug production, the air purification level of the clean room is also different. Common levels are A, B, C, and D.
Air supply method: The clean room should use clean air filtered by high-efficiency filters, and ensure the cleanliness of the indoor air through reasonable airflow organization methods such as laminar flow and turbulent flow.
Pressure difference control: A certain pressure difference should be maintained between the clean room and the adjacent area to prevent pollutants from spreading from low-level areas to high-level areas.
Temperature and humidity control: Appropriate temperature and humidity should be maintained in the clean room to meet the drug production process requirements and personnel comfort.
4. Equipment and facilities
Production equipment: Equipment that meets GMP requirements should be selected and regularly cleaned, disinfected and maintained.
Sanitary facilities: Sanitary facilities such as wash basins, disinfectants, and hand dryers should be equipped, and a strict cleaning and disinfection system should be formulated.
Monitoring system: Monitoring equipment such as dust particle counters and floating bacteria samplers should be installed to monitor the cleanliness of the clean room in real time.
5. Personnel and management
Personnel training: All personnel entering the clean room must undergo strict training and master the operating procedures and hygiene requirements of the clean room.
Personnel hygiene: Before entering the clean room, you must change clothes, wash your hands, and disinfect according to the prescribed procedures.
Management system: A sound clean room management system should be established, including personnel entry and exit system, cleaning and disinfection system, equipment maintenance system, etc., and strictly implemented.
6. Others
Verification and confirmation: After the clean room is built, verification and confirmation should be carried out to ensure that it meets GMP requirements.
Document management: A sound clean room document management system should be established, including design documents, construction documents, verification documents, operating procedures, etc.
Summary:
The construction of a GMP pharmacy clean room is a complex system project that requires comprehensive consideration of site selection, layout, building structure, air purification system, equipment and facilities, personnel management and other aspects. Only by strictly following the GMP requirements can we ensure that the cleanliness of the clean room meets the requirements and provide a safe and reliable environment for drug production.
Please note: The above are just some general requirements. The specific requirements may vary depending on the type of drug and production process.
Post time: Feb-11-2025