The design and operation of clean rooms in pharmaceutical industries must strictly comply with Good Manufacturing Practices (GMP) and other relevant national standards to ensure that the production environment reaches a high level of cleanliness, prevent cross-contamination. And ensure pharmaceutical quality and public medication safety. Here are some of the main requirements:

Classification of air cleanliness

Clean rooms must be constructed in accordance with the design standards specified in the international standard ISO 14644 or the US federal standard FS209E (replaced by ISO), and are divided into different levels, such as ISO 5 to ISO 8, corresponding to the number of particles in the air per cubic meter limit. Class A corresponds to ISO 5,it is suitable for critical areas of sterile preparations.

Air handling system

Clean rooms must be equipped with high-efficiency, multi-stage air purification systems, including fan boxes, primary-efficiency filters, medium-efficiency filters, high-efficiency filters (HEPA), etc., air supply ducts and return air systems. Ensure that the air entering the clean room is purified layer by layer. Remove dust particles and other microorganisms, to ensure indoor air quality meets cleanliness requirements.

The temperature usually needs to be maintained within an appropriate range to avoid being too high or too low, affecting product quality and personnel comfort; humidity also needs to be controlled within a certain range to prevent static electricity accumulation and excessive microbial growth.

In order to ensure the stability of the drug, the temperature and humidity of the clean room need to be strictly controlled, generally around 20-22°C, and the relative humidity is maintained at 45%-65%. If want to know more about it please click here.

Pressure control

Maintain the positive pressure gradient between different clean areas by adjusting the air supply volume and exhaust volume. Prevent polluted air from entering areas with higher cleanliness.

Different clean areas should be set with different pressure gradients. To ensure that the air flows from areas with high cleanliness to areas with low cleanliness.

Particulate and microbial control

Conduct regular particle count testing and take necessary disinfection measures to control the number of microorganisms, such as dynamic sterilization technology, ultraviolet light irradiation, etc.

Facilities and layout

The floors, walls, ceilings, doors, windows and other facilities of the clean room should be smooth, seamless, easy to clean, corrosion-resistant, and free from glare. Wall corners should be rounded or obtuse to reduce dust accumulation. In addition, the layout of the facilities should be reasonable to facilitate cleaning and disinfection.

Personnel and materials entering the clean room should be strictly cleaned and disinfected to reduce the risk of contamination. Establish strict personnel dress regulations, such as personnel need to wear clean clothes, masks, gloves, hats, etc., and other personal protective equipment. 

Air shower, buffer rooms and other facilities are used to purify people entering and exiting the clean room. Materials should enter and exit the clean room according to prescribed routes and requirements. Clearly divide clean areas, non-clean areas, production areas and maintenance areas. Reasonably plan the entry and exit routes for people and materials to avoid cross-contamination.

Lighting and noise control

Clean room lighting should meet production needs while avoiding glare. Lighting facilities should be dust-proof, earthquake-proof, fire-proof and other measures. The illumination should meet the work requirements, and the noise should be controlled at a level that does not disturb the operator and does not affect product quality.

Surface cleaning and disinfection

All product contact surfaces must be easy to clean and disinfect, and cleaning and disinfection procedures must be performed regularly.

Self-purification time

After the production operation is completed, the clean room should be able to return to the static cleanliness level within a certain period of time, that is, to reach the specified self-cleaning state.

Monitoring and maintenance

Continuously monitor various parameters of the clean room (such as temperature and humidity, pressure difference, dust particle count, microorganisms, etc.) and keep detailed records for auditing and quality tracking. Regularly conduct comprehensive testing and maintenance of the clean room, including dust particle counter testing, microbial culture, etc., to ensure the performance and safety of the clean room.

Safety and environmental protection

The clean room of a pharmaceutical factory should comply with national and local safety and environmental protection regulations to ensure that waste gas, waste water and other wastes during the production process are properly treated to prevent adverse effects on the environment.

In short, the requirements for clean room in pharmaceutical industry are very strict and complex. They need to comprehensively consider air cleanliness, temperature and humidity control, air flow control, pressure control, facilities and layout, lighting and noise, personnel and material management, monitoring and recording, regular testing and maintenance, safety and environmental protection. Only by meeting these requirements can the quality and safety of pharmaceutical production be guaranteed.

Suzhou Pharma Machinery Co.,Ltd.

2024/02/07

Spencer