- Apr 11, 2018 -
What are the requirements of the clean laboratory construction layout?
The cleansing project uses air purification technology to implement strict partitioning and shunt management of personnel and articles to achieve the control of dust, microbes, bacteria and other harmful substances in the clean room. At the same time, it effectively prevents the occurrence of cross-infection and achieves clean indoor cleanliness and safety. effect. Requirements for the layout of the clean room: Set the level of cleanliness according to YY 0033-2000 “Guidelines for the Production Management of Sterile Medical Devices” in Appendix B of the Guideline for Setting the Cleanliness Level of Production Environment for Aseptic Medical Devices.
1. According to the level of air cleanliness, it can be written in the direction of people flow, from low to high; the workshop is from the inside to the outside, from high to low.
2. According to the production process layout. The process is as short as possible, reducing the interaction, rational flow of people and logistics. Must be equipped with personnel clean rooms (storage vestibule room, washroom, wear clean work clothes room and buffer room), material purification room (outsourcing, buffer room and double transfer window), in addition to the use of the product process requirements outside, but also Equipped with ware room, laundry room, temporary storage room, station equipment cleaning room, etc. Each room is independent of each other. The area of the clean room should be in line with the production scale under the premise of ensuring basic requirements.
3. Air purification shall comply with the requirements of Chapter 9 of GB 50457-2008 "Plant for the Design of Cleanrooms for Pharmaceutical Industry". The amount of fresh air in the clean room shall be taken as the following maximum: 1) the amount of fresh air required to compensate for the indoor exhaust air volume and the positive pressure in the room; 2) the fresh air in the room shall not be less than 40 cubic meters/h.
4. The per capita area of the cleanroom shall be no less than 4m2 (except corridors, equipment, etc.) to ensure a safe operating area.
5. In the case of in vitro diagnostic reagents should meet the "in vitro diagnostic reagent production implementation rules (Trial)" requirements. The negative, positive serum, plasmid, or blood product handling operations should be carried out in at least 10,000 environments with relatively negative pressure maintained in adjacent areas and in compliance with protection requirements.
6. The direction of return air, air supply and water piping should be marked.
7. No cross-contamination occurs within the same clean room (area) or adjacent clean rooms (areas). The production process and raw materials do not affect product quality; there are air lock chambers or anti-pollution measures between the clean rooms (zones) of different grades, and the material is transported through the double transfer window.
Cleanliness works through the ease of use of purification technology, which can not only effectively control the contamination of microorganisms to meet the clean environment requirements for various types of surgery, but also provide the most suitable temperature and humidity for all personnel to create a Comfortable and sanitary surgical space environment. Guangzhou Kedu Experimental Equipment Engineering Co., Ltd. specializes in solving laminar flow problems in cleanrooms, cleanrooms, and laboratories, and designs solutions based on the actual situation of the company.