Sterile medical devices refer to the non-viable microorganisms on the products. They are medical device products provided by medical device manufacturers in a sterile state, and are sterile medical device products that are directly used by medical institutions and the public without sterilization. Sterile medical device manufacturers establish different levels of production clean environment in accordance with the requirements of "Medical Device Manufacturing Quality Management Regulations", and require strict control in terms of raw materials, production process, personnel hygiene, equipment cleanliness, materials, and flow of people. Pollution is controlled to the acceptable level stipulated by the standard. The production of sterile urinary catheters, tracheal intubation tubes, human lubricants and other medical devices in contact with mucous membranes should be produced in a clean room (area) of no less than 300,000. The use of products must also strictly implement aseptic technique operating procedures. Storage conditions are also strictly regulated, requiring a ventilated and dry room with a relative humidity of less than 80%. Based on relevant corporate consultations, CEIDI has compiled relevant content of the clean workshop for medical device production for sharing.

Layout requirements of clean workshops for medical device production

Set the cleanliness level in accordance with the guidelines for setting the cleanliness level of the production environment of sterile medical devices in Appendix B of YY0033-2000 "Management Regulations for the Production and Management of Sterile Medical Devices". Pay attention to the following aspects in the design of clean room (area):

1. Layout according to the production process. The process should be as short as possible, alternate reciprocation should be reduced, and the flow of people and logistics should be reasonable. Must be equipped with personnel clean room (storage room, washroom, clean work clothes room and buffer room), material clean room (outsourcing room, buffer room and double-layer transfer window), in addition to equipped with the product process requirements of the outdoor room, but also Equipped with sanitary ware room, laundry room, temporary storage room, station equipment cleaning room, etc., each room is independent of each other, and the area of the clean workshop should be compatible with the production scale under the premise of ensuring the basic requirements.

2. According to the air cleanliness level, it can be arranged according to the direction of the flow of people, from low to high; the workshop is from the inside to the outside, from high to low.

3. No cross contamination occurs in the same clean room (area) or between adjacent clean rooms (area)

1) The production process and raw materials will not affect the quality of the product;

2) There are air lock rooms or anti-pollution measures between clean rooms (zones) of different levels, and materials are conveyed through double-layer transfer windows.

4. Air purification should meet the requirements of Chapter 9 of GB 50457-2008 "Code for Design of Clean Workshops in the Pharmaceutical Industry". The amount of fresh air in the clean room should be the following maximum value:

1) Compensate the amount of indoor exhaust air and the amount of fresh air required to maintain positive indoor pressure;

2) No one in the room, fresh air should not be less than 40 cubic meters/h.

5. The per capita area of the clean room should be no less than 4 square meters (except for corridors, equipment and other items) to ensure a safe operation area.

6. If it is an in vitro diagnostic reagent, it should meet the requirements of the "Detailed Rules for the Production of In Vitro Diagnostic Reagents (Trial)". Among them, the processing operation of negative and positive serum, plasmid or blood products should be carried out in an environment of at least 10,000 grades, and the adjacent area or maintain a relatively negative pressure, and meet the protection requirements.

7. The direction of return air, supply air and water pipe should be marked.

Of course, the above content is the standard layout requirement of sterile medical device production workshop. CEIDI received a connection from an enterprise a few days ago, requesting it to plan and design a clean workshop with sterile urinary catheters as its main product, and to undertake packaging repairs and other system projects in the clean field. After fully understanding the current production needs of the plant and the overall status of future planning possibilities, the designer gave a design and decoration plan for a multi-functional medical device complex with a sterile testing room and a production operation room as the mainstay. Soon, it will enter the decoration construction stage.