What Is Cleanroom in Pharmaceutical Industry?

In the pharmaceutical industry, cleanroom plays a vital role, it is like a loyal guardian, guarding every process of drug production, to ensure that the final arrival of patients in the hands of the drug is safe, effective, quality control.

Cleanroom, as the name suggests, is a space where suspended particles, harmful gases, bacteria and other pollutants in the air are strictly controlled. It maintains the indoor environment at a specific clean level through a series of sophisticated air filtration systems, differential pressure control, temperature and humidity regulation, etc., in order to meet the special requirements of different pharmaceutical production.

Pharmaceutical businesses use Clean Room systems across their complete manufacturing cycle:

1. The production of APIs needs highly controlled environments and cleanrooms function to stop microbial contamination which protects both API purity and quality.

2. The high-level Clean Room serves to protect sterile drug production and aseptic preparation manufacturing including injections and ophthalmic medication through its prevention of microbial contamination.

3. The manufacturing process of biological products including vaccines requires stringent environmental conditions because blood products along with other biological products demand high standards. Biological products maintain their proper functioning and safety within cleanrooms due to these environments providing sterilized dust-free conditions.

Cleanrooms are classified according to the concentration and size of suspended particles in the air, and are usually categorized into ISO Class 1 to ISO Class 9, with the smaller the number, the higher the cleanliness level. For example, the production of sterile preparations usually requires a cleanroom of ISO Class 5 or higher.

In order to maintain cleanliness in a cleanroom, a number of stringent measures need to be taken:

1. Personnel who want to access the cleanroom must complete a strict protocol which combines dressing procedures with sanitization requirements and clean suit wearing guidelines.

2. All materials coming into the cleanroom require cleaning procedures followed by sterilization steps through special windows for transfer.

3. The cleanliness level needs to be continually checked by monitoring air and surface microorganisms with suspended particles to confirm it stays within specifications.

Cleanroom is an indispensable infrastructure for the pharmaceutical industry, which provides a reliable guarantee for the safe production of drugs. With the continuous development of pharmaceutical technology, the clean room requirements are also more and more high, the future of the clean room will be towards a more intelligent, more efficient direction of development, for human health escort.

In a word, Cleanroom is the “sterile fortress” of pharmaceutical industry, which builds up a safety barrier with the power of science and technology, guarding every pill and every injection, escorting human health.