Original Title: Relevant Requirements for Clean Workshops for Medical Device Production Relevant requirements for clean workshop of medical device production The Detailed Rules for the Implementation of the Production of In Vitro Diagnostic Reagents (Trial) (GSYJX [2007] No.239) has been implemented since 2007, and the Good Manufacturing Practice for Sterile and Implantable Medical Devices has been implemented since 2011. Announcement No.64 of 2014, the State Administration revised the Good Manufacturing Practice for Medical Devices in July 2015. The General Administration of the People's Republic of China has successively issued the Announcement on Issuing the Appendices to the Quality Management Standards for Medical Device Production for In Vitro Diagnostic Reagents, the Announcement on Issuing the Appendices to the Quality Management Standards for Medical Device Production for Sterile Medical Devices, and the Announcement on Publishing the Appendix to the Standards for Quality Management of Medical Devices Production for Implantable Medical Devices. To further strengthen the production quality requirements of aseptic, implantable and in vitro diagnostic reagents, in the daily supervision process, it is found that the construction of clean delivery rooms in some enterprises is not standardized enough. Therefore, the construction requirements of the clean plant are as follows: I. Standards and working papers currently covered 1. YY 0033-2000 Production Management Specification for Sterile Medical Devices; 2. YY/T 0567.1-2013 Aseptic Processing of Medical Products Part 1: General Requirements; 3. YY/T 0567.2-2005 Aseptic Processing of Medical Products-Part 2: Filtration; 4. GB 50457-2008 Code for Design of Clean Room in Pharmaceutical Industry; 5. Appendix A of the Detailed Rules for the Production of In Vitro Diagnostic Reagents (Trial); 6. Announcement on Issuing the Appendix of Good Manufacturing Practice for Medical Devices Sterile Medical Devices (No.101 of 2015); 7. Announcement on Issuing the Appendix to the Good Manufacturing Practice for Medical Devices Implantable Medical Devices (No.102 of 2015); 8. Announcement on Issuing the Appendix of Good Manufacturing Practice for Medical Devices: In Vitro Diagnostic Reagents (No.103 of 2015). II. Requirements for Site Selection Expand the full text 1. When selecting the plant site, it should be considered that the natural environment and sanitary conditions around the site are good, at least there is no pollution source of air or water, and it should be far away from traffic arteries, freight yards, etc. 2. Environmental requirements of the plant area: the ground and roads of the plant area shall be flat and dust-free. It is advisable to reduce the area of exposed soil through greening or take measures to control dust. Garbage and idle articles should not be stored in the open air. In short, the environment of the factory should not pollute the production of sterile medical devices. 3. The overall layout of the factory area shall be reasonable: no adverse impact on the production area of sterile medical devices, especially the clean area. III. Layout requirements of clean room (area) The cleanliness level shall be set according to the guidelines for setting the cleanliness level of sterile medical device production environment in Annex B of YY 0033-2000 Sterile Medical Device Production Management Specification. Attention shall be paid to the following aspects in the design of clean room (area): 1. Arrange according to the production process flow. The process shall be as short as possible to reduce cross reciprocation, and the flow of people and logistics shall be reasonable. Personnel purification room (outer clothes storage room, washroom, clean work clothes wearing room and buffer room) and material purification room (outer packing removal room, buffer room and double-layer transfer window) must be equipped. In addition to the rooms required by the product process, sanitary ware room, laundry room, temporary storage room and station tool cleaning room should also be equipped. Each room is independent of each other. The area of the clean workshop should be compatible with the production scale on the premise of ensuring the basic requirements. 2. According to the air cleanliness level, it can be written according to the direction of people flow, from low to high; the workshop is from inside to outside, from high to low. 3. No cross contamination in the same clean room (area) or between adjacent clean rooms (areas) 1) The production process and raw materials will not affect the product quality; 2) There are airlocks or anti-pollution measures between different levels of clean rooms (zones), and materials are transferred through double-layer transfer windows. 4. The air purification shall conform to the requirements of Chapter 9 of GB 50457-2008 Code for Design of Clean Workshop of Pharmaceutical Industry. The fresh air volume in the clean room shall take the following maximum values: 1) the fresh air volume required to compensate the indoor exhaust air volume and maintain the indoor positive pressure; 2) the fresh air without people in the room shall not be less than 40 m3/H. 5. The per capita area of the clean room shall not be less than 4 m2 (except for the corridor, equipment and other articles) to ensure a safe operation area. 6. If it is an IVD reagent, it shall comply with the requirements of the Detailed Rules for the Implementation of the Production of IVD Reagents (Trial). The treatment of negative and positive serum, plasmids or blood products shall be carried out in an environment of at least 10,000 levels, with a relative negative pressure maintained in the adjacent area, and shall meet the protection requirements. 7. The direction of air return, air supply and water production pipes shall be marked. IV. Requirements for temperature and humidity 1. Adapt to the production process requirements. 2. If there is no special requirement for the production process, the temperature of the clean room (area) with air cleanliness of one million and ten thousand shall be 20 ℃ ~ 24 ℃,Medical Disposable Coverall, and the relative humidity shall be 45% ~ 65%; the temperature of the clean room (area) with air cleanliness of one hundred thousand and three hundred thousand shall be 18 ℃ ~ 26 ℃, and the relative humidity shall be 45% ~ 65%. If there are special requirements, they shall be determined according to the process requirements. 3. The temperature of the personnel purification room shall be 16 ℃ ~ 20 ℃ in winter and 26 ℃ ~ 30 ℃ in summer. V. Commonly used monitoring equipment Anemometer, dust particle counter, temperature and humidity meter, differential pressure meter, etc. VI. Requirements for Sterile Testing Room The clean plant must be equipped with a sterile testing room (separated from the production area) with an independent clean air conditioning system, which is required to be a local hundred level under the condition of ten thousand levels. Sterility test room shall include: personnel purification room (outer clothes storage room, washroom, clean work clothes wearing room and buffer room), material purification room (buffer room or double-layer transfer window), sterility test room and positive control room. VII. Environmental Inspection Report of the Third Party Inspection Institution Provide the environmental testing report of a qualified third-party testing institution within one year. The testing report shall be attached with a plan indicating the area of each room. 1. There are six items to be tested temporarily: temperature, humidity, pressure difference, ventilation rate, dust count and settling bacteria. 2. The parts to be tested include: (1) Production workshop: personnel purification room; material purification room; buffer area; rooms required by the product process; cleaning room for station appliances, sanitary ware room, Medical Full Body Coverall ,Antivirus Disposable Mask with CE Certificate, laundry room, temporary storage room, etc. (2) Sterile testing room. VIII. Requirements for Catalogue of Medical Devices Produced in Clean Workshop For the sterile medical devices implanted or inserted into the blood vessel and the accessories delivered in single package that need to be subsequently processed (such as filling and sealing) in the local Class 100 clean area under Class 10,000, the cleanliness level of the production area for the processing, final cleaning, assembly, initial packaging and sealing of the (non-cleaned) parts shall not be lower than the 10000 level. For example 1. Implant the blood vessel Such as vascular stents, heart valves, artificial blood vessels and so on. 2. Interventional blood vessel Various intravascular catheters, etc. Uch as a central venous catheter, a stent delivery system, and the like. B) For sterile medical devices implanted into human tissues and directly or indirectly connected to blood, marrow cavity or unnatural cavity or accessories delivered in single package, the cleanliness level of the production areas such as the processing, final cleaning, assembly, initial packaging and sealing of the (uncleaned) parts shall not be lower than Grade 100000. For example 1. Apparatus for implant in human tissues Pacemaker, subcutaneous implant drug delivery device, artificial breast, etc. 2. Direct contact with blood Plasma separator, blood filter, surgical gloves, etc. 3. Devices in indirect contact with blood Infusion set, blood transfusion set, venous needle, vacuum blood collection tube, etc. 4. Bone contact device Intraosseous instruments, artificial bone, etc. (C) The processing, final fine cleaning, assembly, initial packaging and sealing of sterile medical devices or single-packaged (uncleaned) parts in contact with the injured surface and mucous membrane of the human body shall be carried out in a clean room (area) not lower than the 300000 level. For example 1. Contact with damaged surfaces Burn or wound dressings, medical absorbent cotton, absorbent gauze, disposable sterile surgical supplies such as surgical pads, surgical gowns, medical masks, etc. 2. Contact with mucous membranes Sterile urethral catheter, endotracheal intubation, intrauterine device, body lubricant, etc. D) For the primary packaging materials that are in direct contact with the use surface of sterile medical devices and can be used without cleaning, the cleanliness level of the production environment should be set in accordance with the principle of the same cleanliness level as that of the product production environment, so that the quality of the primary packaging materials can meet the requirements of the packaged sterile medical devices. Production shall be carried out in a clean room (area) of not less than 300,000. For example 1. Direct contact Such as the initial packaging materials of drug dispensers, artificial breasts, catheters, etc. 2. No direct contact Initial packaging materials such as infusion sets, blood transfusion sets, syringes, etc. E) Sterile medical devices (including medical materials) with requirements or processed by aseptic operation technology shall be produced in the local Class 100 clean room (area) under Class 10000. For example 1. Uch as anticoagulants in the production of blood bags. Filling of maintenance solution, aseptic preparation and filling of liquid products. 2. Pressing grip of vascular stent Apply medicine. Appendix: Sterile medical devices include medical devices whose products are free of any viable microorganisms by means of terminal sterilization or by aseptic processing techniques. Production technologies that minimize contamination should be used in the production of sterile medical devices to ensure that medical devices are not contaminated or that contamination can be effectively eliminated. Sterility: The state of being free of viable microorganisms on a product. Sterilization: a validated process used to render a product free of any form of viable microorganisms. Aseptic processing: Aseptic preparation and aseptic filling of products in a controlled environment. The environment's air supply, materials, equipment, and personnel are controlled to maintain acceptable levels of microbial and particulate contamination. Sterile medical device: refers to any medical device marked with "sterile". Note: The clean workshop must include a sanitary ware room,CE Certificate KN95 Mask, a laundry room, a temporary storage room, and a cleaning room for station tools. Products produced under purification conditions: refer to the products that are required to be sterile or sterilized at the time of final use. Source Medical Equipment Industry Information Return to Sohu to see more Responsible Editor:. zjyuan-group.com