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Why need to do GMP clean room

Author:Source:Visits:Date:2017/1/3 9:12:12

Cosmetics GMP purification workshop as a "controlled environment", with different from other construction features, although any construction projects include design, completion and acceptance, routine maintenance and other sectors, but the cosmetics GMP clean room also need to debug, testing And comprehensive evaluation to be confirmed, must not act hastily, hastily put into operation.


Cosmetics production needs to establish a clean clean shop main reason



1. Cosmetics used by the raw materials, ingredients easily perishable.

2. Cosmetics in the production process of the cleanliness of the production equipment requirements.

3. Cosmetics production process to produce dust or the use of harmful, flammable, explosive raw materials must use the clean room clean room.

4. Modern cosmetics and people's daily life is closely related to most people use cosmetics.Therefore, the quality of cosmetics should have: safety, stability, usability, useful, so the cosmetics need to determine a good environment in the space Production, manufacturing, that is clean clean room.

5. Bacteria in the manufacture of cosmetics, standing, filling, packaging and other parts of the product can easily cause secondary pollution in accordance with the new version of "cosmetics manufacturers health norms" requirements: the production workshop air bacteria in the total shall not exceed 1000 / Cubic meters, at the same time, semi-finished products storage room, filling room, cleaning container storage room, dressing room and its buffer area must have air purification or air disinfection facilities.

Cosmetics purification workshop air handling principle



Airflow → early air treatment → air conditioning → medium air treatment → air blower → purification pipeline → efficient air outlet → purification workshop → take dust (bacteria) → return air lane → fresh air, the first effect of air treatment. Repeat the above process, You can achieve the purpose of purification.

Cosmetics sterile clean room precautions



1. Safety Precautions Strict aseptic operation to prevent microbial contamination; operators should enter the sterile clean room should turn off the UV lamp first.

2. Sterile clean room should be equipped with aseptic operation between the buffer and between the sterile operation between the cleanliness should reach 10000, the indoor temperature maintained at 20-24 ℃, humidity remained at 45-60%. Should reach 100 levels.

3. Clean room should be kept clean, strictly prohibited to stack debris, to prevent pollution. Prevent all sterilization equipment and media pollution, polluters should stop using.

4. Clean room should be regularly cleaned with a suitable disinfectant to ensure that the cleanliness of sterile rooms meet the requirements.

5. Need to bring into the sterile room equipment, equipment, plates and other items, should be tightly packed, and should be appropriate method of sterilization.

6. Before entering the clean room, the staff must be disinfected with soap or disinfectant and then replaced with special work clothes, shoes, hats, masks and gloves (or 70% ethanol to wipe the hands again) before entering the clean room To operate.

7. Clean room must be opened before use, sterile room, UV lamp irradiation sterilization for more than 30 minutes, and at the same time open the clean bench for the hair.To complete the operation should be promptly clean the sterile room, and then irradiated with ultraviolet light sterilization 20 minute.

8. For the test before the inspection, should keep the packaging integrity, not open, to prevent pollution. Check with 70% alcohol cotton ball disinfection of the outer surface.

9. Where the items with live bacteria must be disinfected before flushing under the faucet, it is strictly forbidden to contaminate the sewer.


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