What are the cleanliness requirements for pharmaceutical clean workshops?

Pharmaceutical cleanrooms are an integral part of modern biopharmaceutical companies and are used to produce high-purity, high-quality biological drugs and medical devices. Due to the sensitivity of these products, pharmaceutical cleanrooms have very high requirements for cleanliness. The following are the reasons why cleanliness is necessary:

 

Indoor hygiene requirements

 

Pharmaceutical cleanrooms must be kept clean and hygienic, which can be achieved through regular cleaning and disinfection, as well as testing of indoor air, water quality, microorganisms, and chemicals.

This is to ensure that the production environment and products meet strict standard requirements and guarantee the quality of pharmaceutical products.

Temperature and humidity control

 

In view of the needs of cell and biological separation production, pharmaceutical clean workshops must maintain appropriate temperature and humidity control. Proper control of temperature and humidity helps maintain the stability of biological preparations and reduces the impact on composition and quality.

 

Air cleanliness requirements

 

The air cleanliness of cleanrooms is usually defined according to GMP cleanliness or ISO standards. The advantage of GMP cleanliness is that it can better control and monitor the guidelines of the pharmaceutical business. The test of air cleanliness in cleanrooms includes testing indicators such as bacteria, fungi, internal particles, external particles and cleanliness. Different levels of cleanliness correspond to different microbial area limits, and the corresponding air purification facilities and process requirements will become more stringent.

 

Different cleanliness level requirements

 

Pharmaceutical cleanrooms can be divided into different cleanliness levels or clean areas according to the needs of different operations and objectives.

Usually, they need to be classified based on the difference between high, medium, and low cleanliness requirements. Different cleanliness levels require different filters and dust removal equipment. Under high cleanliness requirements, more efficient air filters and airflow control equipment are required to filter and control microorganisms and dust particles. At the same time, the corresponding requirements and specifications must be followed during operation.

In short, the pharmaceutical clean room has relatively high requirements for cleanliness and needs to be equipped with professional operating procedures and advanced clean technology, as well as clean equipment, such as liquid tank HEPA filters, pharmaceutical pass box, air showers, etc. They must be operated and monitored in strict accordance with GMP and ISO standards to ensure that the production environment and products meet the standard requirements and achieve the purpose of producing high-quality products.