For the biopharmaceutical industry, the cleanliness level of the cleanroom is particularly important. People are the biggest "source of pollution" in the cleanroom. In order to reduce personnel pollution to the clean environment and consider the health protection needs of operators, all personnel entering the cleanroom must wear clean clothing. This article explains the requirements of different cleanliness levels for clean clothing based on Chinese GMP and other regulatory requirements.

The requirements for production management and quality management in the "Good Manufacturing Practice for Drugs" aim to minimize the risks of contamination, cross contamination, confusion, errors, etc. in the drug production process. Personnel are the most important element in implementing various operations, and they are also the control difficulty in preventing cross contamination. Effective protection of personnel can effectively avoid cross contamination. Clean clothing provides important protection for personnel, and the management, selection, and use of clean clothing have become crucial.

Article 24 of the regulations on sterile drugs stipulates that work clothes and their quality should be suitable for the requirements of production operations and the cleanliness level of the operating area. Their style and wearing methods should be able to meet the requirements for protecting products and personnel. The dress code requirements for Class A/B clean areas stipulate that all hair, beard, and other related parts should be covered with a hood. The hood should be tucked into the collar, and a mask should be worn to prevent the emission of droplets. If necessary, protective goggles should be worn. Rubber or plastic gloves that have been sterilized and free of particulate matter (such as talcum powder) should be worn, and foot covers that have been sterilized or disinfected should be worn. The pant legs should be tucked into the foot covers, and the cuffs should be tucked into the gloves. Work clothes should be sterilized one-piece work clothes specifically designed for clean rooms, without shedding fibers or particles, and able to retain particles emitted by the body.

Dress code requirements for Class C clean areas: hair, beard, and other related areas should be covered, and masks should be worn. Wear a jumpsuit that can be tightened at the wrist or a work uniform with separate clothes, and wear appropriate shoes or shoe covers. Work clothes should not shed fibers or particles.

Dress code requirements for D-level clean areas: hair, beard, and other related areas should be covered. Suitable work clothes and shoes or shoe covers should be worn. Appropriate measures should be taken to avoid introducing pollutants outside the clean area.

In addition, personal clothing is not allowed to be brought into the changing room leading to the B/C level area. Each employee should change into sterile work clothes every time they enter the A/B level area. During operation, gloves should be disinfected regularly and masks and gloves should be replaced if necessary.