"Medical Device Manufacturing Quality Management Standard" stipulates that: for sterile medical devices that are in direct or indirect contact with the cardiovascular system, lymphatic system or cerebrospinal fluid or medicinal fluids, if the water is a component of the final product, water for injection in accordance with the requirements of the "People's Republic of China * * * and the National Pharmacopoeia" should be used; if used for the end of the cleaning, water for injection or equivalent requirements produced by other methods such as ultrafiltration should be used in accordance with the requirements of the "Chinese people * * * and the National Pharmacopoeia"; with human tissues or natural cavities. * and the National Pharmacopoeia" requirements of water for injection or water for injection produced by other methods such as ultrafiltration and other equivalent requirements; and sterile medical devices in contact with human tissue, bone cavities or natural cavities, the water used for end-path cleaning shall be purified water that meets the requirements of the "Chinese People's *** and the National Pharmacopoeia".
"Aseptic medical device production management norms" (YY0033-2000) standard provisions: equipment, equipment and products in direct contact with the parts of the worktable, workstation appliances should be regularly cleaned, disinfected, to maintain clean, clean area (room) workstation appliances should be in the clean zone (room) with purified water for cleaning, disinfection.
According to the requirements of the regulations, process water is mainly used in the production of sterile medical devices, implantable medical devices, in vitro diagnostic reagents production enterprises for product cleaning, preparation, clean clothing cleaning, cleaning of workstation appliances, environmental cleaning and as a test reagent preparation of the substrate, etc..
(a) the main use of process water
1. drinking water: mainly used for equipment cooling, some parts, station apparatus cleaning, etc.
2. purified water: mainly used for parts of the cleaning, production process cooling water, station apparatus cleaning, clean area (room), work surface cleaning, disinfectant preparation, internal packaging cleaning and as a dosage of water;
2. purified water: mainly used for parts cleaning, cooling water, workplace apparatus cleaning, clean area (room), work surface cleaning, disinfectant preparation, internal packaging cleaning and as a dosage of water;
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Purified water applicable products: orthopedic implants medical devices, intrauterine devices, in vitro diagnostic reagents.
3. Water for injection: mainly used for end-of-passage cleaning of spare parts in direct contact with the liquid, product dosage water, water reservoir cleaning, internal packaging cleaning, etc.
Water for injection applicable products: single-use sterile medical devices such as syringes, implantable medical devices such as intravascular stents, filler materials, allogeneic medical devices, medical devices of animal origin, etc.
Water for injection applicable products: orthopedic implants medical devices, intrauterine devices, extravasation reagents.
4. Sterilization of water for injection: dosage water.
(B) other requirements for the use of process water
The contamination of water quality will bring to the medical device production environment and products. Such as workstation appliances, clean clothes use water that does not meet the standard for cleaning, will inevitably increase its own colony number, thus contaminating the medical device production process and its production environment.
1. final packaging containers if the packaging of medical devices is directly in contact with blood or medicinal fluids, or implanted in the human body of sterile medical devices, the packaging containers of the end of the cleaning application of water for injection. With what kind of process water to clean the workplace apparatus and clean clothes, the general principle is to match the items in the clean area (room) of the clean level, respectively, cleaning, do not cause contamination of the contact spare parts.
2. Clean work clothes of the end of the cleaning at least with purified water, sterile work clothes of the end of the cleaning should use water for injection. Workstation apparatus cleaning water depends on the cleanliness level and to contact the use of parts, but the end of the cleaning at least with purified water, if pre-installed end of the cleaning with water injection parts, then the end of the cleaning should use water injection.
3. For non-sterile implantable devices, water for injection shall be used if water is a component of the final product.
4. Enterprises outsourcing or purchasing semi-finished products, parts and internal packaging bags, should identify the semi-finished products, parts and internal packaging bags provided by the state, whether or not the process water cleaning.
5. Enterprises producing medical devices in the process of inspection, such as involving the use of process water for leak detection, should be based on the characteristics of the production of products and uses, the use of the corresponding process water.
Medical device manufacturers should be strictly in accordance with the "sterile medical device production management norms" (YY0033-2000) standard requirements, do a good job in the auxiliary use of process water. Clean clothes cleaning, for example, enterprises can directly use purified water to clean clothes, can also use drinking water to clean clothes for rinsing, and then use purified water for cleaning. In this regard, the enterprise should be combined with its own actual situation to develop clean clothing cleaning instructions.
Some companies do not use process water due to the production of special materials, such as absorbable sutures, absorbent hemostatic materials. Because the above products have the characteristics of water dissolved, so the use of organic substances, such as the use of alcohol instead of process water for cleaning.