As consumer expectations for product quality continue to rise, the pharmaceutical industry and related sectors are actively striving to meet the standardized Good Manufacturing Practice (GMP) requirements. A key focus of GMP, both domestically and internationally, is maintaining a sterile, dust‑free production environment—commonly referred to as a GMP‑compliant cleanroom.

At present, GMP‑compliant cleanrooms have become widespread and are being actively promoted throughout China, yet pharmaceutical companies remain cautious in the design and construction of such facilities. However, existing national standards do not provide specific guidance on the selection of equipment and materials in cleanroom design. For reasons of cost and technical constraints, contractors often adopt conservative and outdated approaches when choosing materials and components, and many newly built or retrofitted facilities lack the requisite expertise in this area. Consequently, once completed, GMP‑compliant cleanrooms in pharmaceutical manufacturing plants frequently suffer from short service lives, energy inefficiencies, and operational and maintenance challenges—issues that stem from designs that are either inadequate or fail to meet GMP requirements.

Cosmetics are perishable products, so their production is subject to specific requirements. This specialized environment is known as a GMP‑compliant cleanroom. A key feature of GMP cleanrooms is that they minimize or eliminate opportunities for microorganisms to exist or proliferate. Why can GMP cleanrooms be used in the cosmetics industry?

1. At room temperature, the raw materials and ingredients used in cosmetic manufacturing are prone to degradation, resulting in non‑compliant products.

2. During cosmetic manufacturing, stringent cleanliness standards are required for production equipment; otherwise, cross-contamination is likely to occur.

3. The air contains particulate matter, harmful airborne contaminants, bacteria, and other pollutants, which can easily lead to secondary contamination during the manufacturing, storage, filling, and packaging of cosmetics.

4. To ensure the quality of cosmetics, they must meet standards for safety, stability, usability, and practicality. Therefore, manufacturing should take place in a controlled environment—specifically, a GMP‑compliant cleanroom.

5. The semi-finished cosmetic storage room, the filling room, the clean container storage room, the changing room, and their buffer zones must be equipped with air purification or air disinfection systems; the clean‑room cosmetics workshop is capable of providing a clean environment.

6. In cosmetic manufacturing, if dust‑generating or hazardous, flammable, and explosive raw materials are used, a GMP‑compliant cleanroom is required; otherwise, unnecessary accidents can easily occur.

The purification performance of a GMP cleanroom must adhere to certain compliance principles:

1. Strict aseptic techniques must be followed to prevent microbial contamination; personnel should turn off the ultraviolet lamp before entering the sterile room.

2. The aseptic room shall be equipped with an aseptic operating room and a buffer room. The cleanliness level of the aseptic operating room shall meet Class 10,000, with an indoor temperature of 20–24°C and a relative humidity of 45–60%.

3. The aseptic room shall be regularly disinfected and cleaned with an appropriate disinfectant to ensure that the cleanliness level of the GMP‑compliant cleanroom meets the required standards.

4. Before entering the aseptic room, operators must wash their hands and then change into dedicated workwear, shoes, caps, masks, and gloves in the buffer room before proceeding to the GMP‑compliant cleanroom for operations.