Overview: medical device clean room: refers to the "supervision and management of medical devices regulations" and "quality management standard for the production of medical devices," the requirements of the construction of the production of medical devices to meet the requirements of the second and third class of clean room.
Table of Contents:
1.Structure Material
2.Purification Principle
3.Selection Basis for Workshop Purification Level
1.Structure Material
1.Structure part of the general purification plant wall, roof panels are generally more than 50mm thick sandwich color steel manufacturing, which is characterized by beautiful, strong rigidity, good heat preservation performance, easy to Construction. Rounded corners, doors, window frames, etc. are generally used for special purification of special profiles manufactured
2. The ground can be used epoxy self-flowing floor or high-level wear-resistant plastic flooring, anti-static requirements, can choose anti-static type.
3. The air supply and return ducts are made of hot zinc plate, and the flame retardant pf foam plastic plate with good purification and heat preservation effect is affixed.
4. High-efficiency air supply outlet generally with cold-rolled plate shear welding into a static pressure box after plastic spraying, and then inlaid with a good fixed high-efficiency filters, beautiful and clean, perforated mesh plate with baking paint aluminum, not rust, not sticking to the dust, and is suitable for cleaning.
2. Purification principle
Airflow → primary purification → humidification section → heating section → surface cooling section → intermediate purification → fan air supply → pipeline → high-efficiency purification of air → blowing into the room → take away the dust, bacteria and other particles
→
Return louvers → primary purification
Repeat the above process, you can achieve the purpose of purification.
3.
Selection of the workshop purification level based on
1), sterile medical devices should be used in the production of contamination to minimize the production technology,
to ensure that medical devices are not contaminated or can effectively exclude pollution.
2), implanted and intervened in the blood vessels and need to be in the class 10,000 local class 100 clean area
subsequent processing (such as filling and sealing, etc.) of sterile medical devices or single-package factory accessories, its (non-cleaned) parts and components of the processing, the end of the cleaning, assembling, packaging and sealing of the initial production area should not be less than 10,000 cleanliness level. (e.g. vascular stents, blockers, pacing electrodes, artificial blood vessels, intravascular catheters, stent delivery systems, etc.
3), implanted into human tissue, and blood, bone marrow cavity or non-natural lumen of the sterile medical device or a single-package ex-factory accessories, the (non-cleaned) parts and components of the processing, end-of-passage cleaning, assembly, packaging and sealing of the initial production area should be not less than Class 100,000 cleanliness level. (Examples: pacemakers, drug delivery devices, breast implants, artificial larynxes, percutaneous drainage tubes (devices), hemodialysis catheters, blood separators or filters, syringes, infusion sets, blood transfusion sets, bone plates and nails, joint prostheses, bone cements...).
4), with the human body damage to the surface and mucous membranes in contact with the sterile medical devices or single-package factory (without washing) parts of the processing, final washing, assembly, primary packaging and its sealing should be not less than 300,000 class clean room (area). (For example: sterile dressings, natural lumen of the catheter, tracheal intubation, sterile preservation of appliances and other labeled sterile appliances, etc.)
5), and the use of sterile medical devices directly in contact with the use of surfaces, not cleaned that is to be used for the initial packaging materials, its production environment cleanliness level should follow the production environment with the same principle of the cleanliness of the level of the environment, so that the initial packaging materials to meet the quality of packaged Requirements for sterile medical devices, if the primary packaging materials are not in direct contact with the use of sterile medical devices on the surface,
Should be produced in not less than 300,000 clean room (area). (Part of the need but not up to 100,000 and above the cleanliness requirements of the production of internal packaging materials, the enterprise procurement after the necessary cleaning, sterilization, verification processing).
6), for the requirements or the use of aseptic operation techniques for processing sterile medical devices (including medical materials), should be 10,000 under the partial 100 class clean room (area) for production. (e.g., encapsulation of products derived from animal tissues, filling of blood bags, etc.)