Medical supplies purification workshop, medical device GMP purification workshop

Medical product purification workshop, medical device purification workshop
Medical product purification workshop, medical device purification workshop: refers to the regulations based on the "Medical Device Supervision and Management Regulations" and the "Medical Device Production Quality Management Standards" Requirements for the construction of clean rooms that meet the production requirements for Class II and Class III medical devices. . Structural materials. For structural parts, the walls and roofs of purification plants are generally made of thick sandwich color steel plates, which are characterized by beautiful appearance, strong rigidity, good thermal insulation performance, and easy construction. Arc corners, doors, window frames, etc. are generally made of special purification-specific profiles. .The ground can be made of epoxy self-leveling floor or high-grade wear-resistant plastic floor. If there are anti-static requirements, anti-static type can be selected. .The air supply and return ducts are made of thermally bonded zinc sheets and are adhered to flame-retardant foam plastic sheets with good purification and thermal insulation effects. .High-efficiency air supply outlets are generally made of cold-rolled plates sheared and welded into a static plenum, sprayed with plastic, and then inlaid and fixed. The high-efficiency filter is beautiful and clean. The perforated mesh plate is made of baked-painted aluminum plate that does not rust or stick to dust and should be cleaned. .Purification principle: Air flow, initial effect purification, humidification section, heating section, surface cooling section, medium effect purification fan, air supply duct, high-efficiency purification air outlet blows into the room to take away particles such as dust, bacteria, etc. Return air louvers, initial effect purification, repeat the above process to achieve the purpose of purification. . Basis for selection of workshop purification level), production technology that minimizes contamination should be used in the production of sterile medical devices to ensure that medical devices are not contaminated or can effectively eliminate contamination. ), implantation and intervention into blood vessels, and sterile medical treatment that requires subsequent processing (such as filling and sealing, etc.) in a local 100-level clean area under the 10,000-level... Medical device purification workshop: refers to the medical device purification workshop according to the "Medical Device Clean rooms that meet the production requirements of Class II and Class III medical devices shall be constructed in accordance with the requirements of the Supervision and Administration Regulations and the Good Manufacturing Practice for Medical Devices. . Structural materials. For structural parts, the walls and roofs of purification plants are generally made of thick sandwich color steel plates, which are characterized by beautiful appearance, strong rigidity, good thermal insulation performance, and easy construction. Arc corners, doors, window frames, etc. are generally made of special purification-specific profiles. .The ground can be made of epoxy self-leveling floor or high-grade wear-resistant plastic floor. If there are anti-static requirements, anti-static type can be selected. .The air supply and return ducts are made of thermally bonded zinc sheets and are adhered to flame-retardant foam plastic sheets with good purification and thermal insulation effects. .High-efficiency air supply outlets are generally made of cold-rolled plates sheared and welded into a static plenum, sprayed with plastic, and then inlaid and fixed. The high-efficiency filter is beautiful and clean. The perforated mesh plate is made of baked-painted aluminum plate that does not rust or stick to dust and should be cleaned. .Purification principle: Air flow, initial effect purification, humidification section, heating section, surface cooling section, medium effect purification fan, air supply duct, high-efficiency purification air outlet blows into the room to take away particles such as dust, bacteria, etc. Return air louvers, initial effect purification, repeat the above process to achieve the purpose of purification. . Basis for selection of workshop purification level), production technology that minimizes contamination should be used in the production of sterile medical devices to ensure that medical devices are not contaminated or can effectively eliminate contamination. ), sterile medical devices that are implanted and inserted into blood vessels and require subsequent processing (such as filling and sealing, etc.) in a local 100-level clean area under 10,000 level or single-packaged factory accessories and their (not cleaned) parts The production areas such as final processing cleaning, assembly, initial packaging and sealing should not be lower than the first grade cleanliness level. (For example: vascular stents, occluders, pacing electrodes, artificial blood vessels, intravascular catheters, stent delivery systems, etc.), implanted in human tissue, directly or indirectly connected to blood, bone marrow cavity or unnatural channels. For bacterial medical devices or single-packaged accessories shipped from the factory, the production areas such as processing, final cleaning, assembly, initial packaging and sealing of non-cleaned parts should not be lower than grade 1 cleanliness level. (For example: pacemaker, drug injector, [prohibited word] implant, artificial larynx, percutaneous drainage tube (appliance), hemodialysis catheter, blood separation or filter, syringe, infusion set, blood transfusion set, bone Purification workshops for bone screws, joint prostheses, and bone fluid medical devices: refer to clean workshops built in accordance with the requirements of the "Regulations on the Supervision and Administration of Medical Devices" and the "Good Manufacturing Practice for Medical Devices" to meet the production requirements of Class II and Class III medical devices. room.