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Relevant requirements for clean workshop

2022-10-27 00:48   For Sale   Bulaon   197 views

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Location: Bulaon
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Original Title: Relevant Requirements for Clean Workshops for Medical Device Production Relevant requirements for clean workshop of medical device production The Detailed Rules for the Implementation of the Production of In Vitro Diagnostic Reagents (Trial) (GSYJX [2007] No.239) has been implemented since 2007, and the Good Manufacturing Practice for Sterile and Implantable Medical pecially dry room, temporary storage room and station tool cleaning room should also be equipped. Each room is independent of each other. The area of the clean workshop should be compatible with the production scale on the premise of ensuring the basic requirements. 2. According to the air cleanliness level, it can be written according to the direction of people flow, from low to high; the workshop is from inside to outside,KN95 Face Mask, from high to low. 3. No cross contamination in the same clean room (area) or between adjacent clean rooms l cequirement for the production process, the temperature of the clean room (area) with air cleanliness of one million and ten thousand shall be 20 ~ 24 ,free shipping disposable coverall, and the relative humplan indicating the area of each room. 1. There are six items to be tested temporarily: temperature, humidity, pressure difference, ventilation rate, dust count and settling bacteria. 2. The parts to be tested include: (1) Production workshop: personnel purification room; material purification room; buffer area; rooms required by the product process; cleaning room for station appliances, sanitary ware room, Medical Full Body Coverall ,KN95 Face Mask with Five Layers, laundry room, temporary storage room, etc. (2) Sterile testing room. VIII. Requirements for Catalogue of Medical Devices Produced in Clean Workshop For the sterile medical devices ssing: Aseptic preparation and aseptic filling of products in a controlled environment. The environment's air supply, materials, equipment, and personnel are controlled to maintain acceptable levels of microbial and particulate contamination. Sterile medical device: refers to any medical device marked with "sterile". Note: The clean workshop must include a sanitary ware room,Medical Disposable Coverall, a laundry room, a temporary storage room, and a cleaning room for station tools. Products produced under purification conditions: refer to the products that are required to be sterile or sterilized at the time of final use. Source Medical Equipment Industry Information Return to Sohu to see more Responsible Editor:. zjyuan-group.com

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