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GMP workshop cleanroom

Release time:

2026-02-25 11:47

A GMP workshop cleanroom is a specialized production space that achieves contamination isolation through partitioned design and environmental control. All its components work in synergy to ensure that the production environment meets the required standards.

I. Core Functional Area

Cleanrooms are categorized by function into production operation areas, quality control areas, and storage areas. The production operation area includes clean corridors and various operational rooms, with cleanliness levels determined according to process requirements. The quality control area is equipped with facilities such as microbial limit testing rooms and sterility testing rooms, which must be physically separated from the production area. The storage area comprises a receiving zone, a shipping zone, a sampling zone, and an isolation zone for nonconforming products, all of which meet the necessary conditions for material storage.

II. Personnel Purification System

Personnel entering the cleanroom must go through a complete purification process: change into dedicated shoes in the shoe-changing room, store personal clothing in the outerwear storage room, wash and disinfect hands in the washroom, change into specialized cleanroom attire in the cleanroom garment changing room, and then enter the cleanroom via an airlock or air shower room. It is advisable that faucets in each zone be designed to avoid direct hand contact, and the airlock doors are equipped with measures to prevent them from being opened simultaneously.

III. Material Purification System

Materials entering the clean zone must pass through the raw and auxiliary material outer packaging cleaning room, the packaging material cleaning room, and the sterilization room for processing. The transfer facilities include pass-through windows (where the doors on both sides cannot be opened simultaneously) and airlocks. The waste disposal exit should not be shared with the material import; rather, it should be set up separately.

IV. Architectural Structure and Materials

The wall surfaces are made of antibacterial electrolytic steel plates or rockwool-colored steel panels, which are smooth, dust-free, and corrosion-resistant. The joints feature rounded transitions. The floor is covered with seamless, antistatic PVC material, with a surface resistance maintained between 10⁶ and 10⁹ Ω. Lighting fixtures are recessed into the ceiling, providing an illuminance of no less than 300 lux. Doors open in the direction of higher cleanliness levels and also in the evacuation direction in case of emergency.

V. Air Purification System

The system is equipped with a three-stage filtration system comprising primary (G4 grade), medium-efficiency (F8 grade), and HEPA (H13 grade) filters. For Class A cleanrooms, laminar flow technology (either horizontal or vertical) is employed; lower-grade cleanrooms utilize non-unidirectional airflow. Environmental control parameters: temperature 18–26°C, relative humidity 45–65%, and air exchange rates are set according to the requirements of each cleanliness class.

VI. Auxiliary Facilities

The air cleanliness of the equipment cleaning room shall be the same as that of the use area. The storage room for cleaning tools shall be regularly disinfected. Drain outlets shall be equipped with backflow prevention devices; Class A/B areas shall not have sink floor drains, while Class D areas shall have floor drains fitted with sealed covers and water traps. Compressed air and nitrogen coming into contact with pharmaceuticals must undergo oil removal, dehumidification, and dust removal treatments.

7. Pressure Differential and Buffering

The pressure difference between clean areas and non-clean areas shall be ≥10 Pa, and the pressure difference between clean areas of different levels shall also be ≥10 Pa. The positive-bacteria room shall maintain negative pressure relative to the corridor, while the corridor shall maintain positive pressure of 5 Pa relative to the buffer zone. The buffer zone shall have an area of no less than 3 m² and shall be equipped with HEPA air supply.

8. Environmental Monitoring

Regularly monitor suspended particles, airborne microorganisms, settling microorganisms, temperature and humidity, pressure differentials, and illuminance, with validation conducted every six months. Surface microbial requirements shall be in accordance with the specified cleanliness levels.

9. Pest Control Facilities

Install rodent-proof boards, use fly traps, seal doors and windows, and implement regular pest control measures.

 

Each part of the GMP workshop’s cleanroom performs specific contamination-control functions—from personnel purification to material transfer, from air handling to surface materials—collectively forming a comprehensive barrier that safeguards the production environment.

 

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