The decoration of the clean workshop for the production of 100,000-level medical masks for protective second-class medical devices in Zhejiang_

Medical devices are divided into 3 categories. Masks belong to the second category of medical devices. Whether it is a medical cup-shaped protective mask or a disposable medical mask, the production environment must be produced in a clean workshop of class 100,000 (medical name: Class D clean workshop) or above. This is a national mandatory requirement. The production environment must be dust-free and sterile. Masks with special requirements must be produced under the specified constant temperature and humidity range. Let's take a look at the decoration case of sz-pharma's clean workshop for the production of 100,000-level medical masks for Class II medical devices of a Zhejiang XX protection company! It is a mandatory national requirement that the production environment of medical masks must be a clean workshop of class 100,000 or above. Its standard: dust-free, sterile. Some masks with special requirements must be produced under constant thermometer humidity. About the project: Decoration of clean workshop for medical mask production Project location: Zhejiang Contractor: Shanghai sz-pharma Project name: Class 100,000 clean workshop for the production of second-class medical devices (medical name: Class D clean workshop) Project type: Construction/project management industry Category: Class II medical devices Completion time: June 2020 Construction area: about 1,600 square meters Logistics aspects of the clean pharmaceutical cleanroom: 1. Selection of raw materials for the production process of medical cup-shaped protective masks>> hot pressing>> Manufacture of outer cover>> Weld Trim>> Printing mask labels>>

Breathing valve punch>> Nose bridge welding>> Manual/machine sticking inner nose bridge strip>> Welded ear straps>> Welded breathing valve>>

Finished product insourcing workshop>> External integrated packaging>> Storing/shipping 2. Material transportation process From the initial selection of raw materials to the final packaging, the whole process must be dust-free and sterile. The layout of the workshop should be reasonable, the process flow should be smooth, the connection between the upper and lower processes should be smooth, the transportation distance should be short and straight, and circuitous and round-trip transportation should be avoided as much as possible. Class 100,000 clean room standard: When the class 100,000 clean room has no special requirements for temperature and humidity, it is advisable to wear clean work clothes without feeling comfortable.

24~26℃, fluctuation ±2℃; the humidity of clean room in winter is controlled at 30-50%, and the humidity of clean room in summer is controlled at 50-70%. Standard 1: The maximum allowable number of dust particles ≥ 0.5 microns does not exceed 3.5 million, and the number of particles ≥ 5 microns does not exceed 20,000. Standard 2: The maximum allowable number of microorganisms, the number of planktonic bacteria does not exceed 500/m; the number of settled bacteria does not exceed 10/Petri dish. Standard 3: Differential pressure. The pressure difference between clean rooms of the same cleanliness level should be consistent. The pressure difference between adjacent clean rooms of different cleanliness levels should be ≥5Pa, and the pressure difference between the clean room and the non-clean room should be ≥10Pa (mainly to ensure that the air flows from the clean area to the non-clean room). clean area to avoid airflow backflow). GB19083-2010 Technical Requirements for Medical Protective Masks SICOLAB medical mask clean workshop design and decoration A corner of the mask production workshop, workshop workers are producing medical masks. Clean workshop decoration Scan the QR code pattern below, add me on WeChat, get a free design quotation

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