Important Considerations for Operating a Sterile Cleanroom:

The use of sterile cleanrooms in the manufacture of food and beverage products follows the same principles that are laid out in the GMP (Good Manufacturing Practice) for pharmaceutical manufacturing. The goal is to minimize potential contaminants in the form of dust particles and microorganisms in order to increase product safety and quality.

(1) For personal safety reasons, all personnel entering the cleanroom should first turn off all UV lights.

(2) Sterile cleanrooms and buffer areas should be designed to meet FS209E level 10,000 (ISO 7). Cleanroom temperature should be maintained between 20-24℃ with a humidity level between 45-60%. All workstations should meet FS209E level 100 (ISO 5).

(3) In order to maintain a sterile environment, strict precautions must be taken to avoid contamination of the cleanroom and any cleaning equipment. Operator should immediately discontinue use of any contaminated equipment or item.

(5) The cleanroom should be cleaned regularly with a disinfecting agent.

(6) Any machinery, device, lab equipment, etc. should be thoroughly disinfected and sealed before it is taken into the sterile cleanroom.

(7) All personnel must disinfect their hands with soap and/or disinfectant before entering the buffer area. In the buffer area, they should then change put on shoes and clothing approved for use in the clean area, and also put on approved hats/hairnets, masks, and gloves (or wash their hands again with hand disinfectant.)

(8) Before using the sterile cleanroom, the UV lights should be turned on for at least 30 minutes. At the same time, the fans on the clean benches should be turned on. After turning out the UV lights, cleanroom surfaces should be thoroughly cleaned with disinfectant, and then the UV lights should be turned on for another 20 minutes.

(9) When inspecting test samples make sure that the packaging is completely sealed, and do not open the packaging in order to avoid contamination. Before inspection, wipe down the outer surface of the test sample container with a cotton ball dipped in 70% isopropyl alcohol.

(10) Any items containing living organisms or bacteria must be disinfected before being washed in the sink to avoid contamination of the pipes.