Overview: medical device purification workshop: refers to the "supervision and management of medical devices regulations" and "medical device production quality management norms," 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. structural materials
2. purification principle
3. workshop purification level selection basis
1. structural materials
1. structural part of the general purification plant walls, roof panels are generally more than 50mm thick sandwich color steel manufacturing, which is characterized by beautiful, strong rigidity, good thermal insulation performance, easy to construct. Rounded corners, doors, window frames and other general use of special purification special profile manufacturing.
2. The ground can be used epoxy self-flowing floor or high-level wear-resistant plastic flooring, anti-static requirements, anti-static type can be selected.
3. The air supply and return ducts are made of hot-dip zinc plate, and the flame-retardant PF foam plastic plate with good purification and heat preservation effect is affixed.
4. High-efficiency air supply is generally made of cold-rolled plate shear welded into a static pressure box after plastic spraying, and then inlaid and fixed high-efficiency filters, beautiful and clean, perforated mesh plate with baked aluminum, not rust, not sticking to the dust, and it is appropriate to clean.
2. Purification principle
Airflow → primary purification → humidification section → heating section → surface cooling section → intermediate purification → fan air supply → pipeline → high-efficiency purification of the air blowing into the room → to take away the particles of dust and bacteria → back to the air shutters → primary purification Repeat the above process, you can achieve the purpose of purification.
3. Workshop purification level selection based on
1), sterile medical devices should be used in the production of contamination to minimize the production technology,
in order to ensure that the medical device is not contaminated or can effectively exclude contamination.
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 If the primary packaging materials are not in direct contact with the surface of sterile medical devices, they should be produced in a clean room (area) of not less than 300,000. (Part of the need but not up to 100,000 and above the cleanliness requirements of the production of internal packaging materials, enterprises should be purchased after the necessary cleaning, sterilization, verification process).
6), for the requirements or the use of aseptic operation technology processing of sterile medical devices (including medical materials), should be in the 10,000 level under the local level 100 clean room (area) for production. (e.g., encapsulation of products derived from animal tissues, filling of blood bags, etc.)