BIO-PHARMA SOLUTION

Generally speaking, the clean area of ​​a pharmaceutical cleanroom is divided into different levels according to the GMP standard, and each level has its corresponding cleanliness requirements.

We can choose different levels of pharmaceutical clean workshops according to different production needs. The following are the requirements for GMP cleanliness levels for clean areas of various common biopharmaceutical workshops:

Aseptic production workshop: Aseptic production workshops are used to produce sterile drugs, such as injections, eye drops, etc. Under GMP regulations, the clean areas of such workshops need to meet the highest level of cleanliness, usually GMP Class A.

Biologics workshop: Biologics workshops are used to produce biological drugs, such as antibody drugs, vaccines, etc. The cleanliness level requirements for clean areas in such workshops may vary depending on the production process, but usually, at least GMP Class B is required.

Cell culture workshop: Cell culture workshops are used for cell culture-related operations, such as cell separation, cell culture, cell freezing, etc. The cleanliness level requirements for clean areas in such workshops may vary depending on the operation, but usually, at least GMP Class C is required.

Hazardous substance handling workshop: Hazardous substance handling workshops are used to handle hazardous substances, such as radioactive substances, toxic drugs, etc. The cleanliness level requirements of the clean area of ​​this type of workshop may vary depending on the hazard of the substance and the processing process, but usually, at least GMP Class D is required.

Our products can meet the needs of products meeting GMP certification in a pharmaceutical cleanroom environment.