Class III 6864 medical sanitary materials-Rongxing

Yung HingClean RoomDecoration

　　Project Name：Taizhou Rongxing Medical Supplies Co.

　　Project content：Purification project

　　Industry Category：Medical equipment purification project

　　■About Yung Hing

　　Taizhou Rongxing Medical Supplies Co., Ltd, established on November 27, 1996, the business scope includes three types of 6864 medical sanitary materials and dressings, two types of 6808 abdominal surgical instruments, 6823 medical ultrasonic instruments and related equipment manufacturing, sales, etc.

　　Rongxing main production of sterile medical gauze, construction area of 2400 square meters, clean room grade 100,000, temperature: 18-26 degrees, humidity 55±10%. The 100,000-grade clean workshop constructed by Shanghai Lixing, with water-cooled air conditioning system and Siemens remote intelligent APP control system. The whole production line meets the requirements of GMP cleanroom certification.

　　Medical device surgical gauze dressing (Class II) product registration applicable standards are as follows：

　　GB 15980-1995 health standards for single-use medical supplies

　　GB/T 16886.1-2001 Biological evaluation of medical devices Part 1: Evaluation and testing

　　GB/T 16886.5-2003 Biological evaluation of medical devices Part 5: In vitro cytotoxicity test

　　GB/T 16886.7-2001 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residues

　　GB/T 16886.10-2005 Biological evaluation of medical devices Part 10: Stimulation and delayed hypersensitivity test

　　GB 18278-2000 Sterilization confirmation and routine control requirements for healthcare products Industrial humid heat sterilization

　　GB 18279-2000 Medical devices Ethylene oxide sterilization confirmation and routine control

　　GB 18280-2000 Sterilization confirmation and routine control requirements for healthcare products Radiation sterilization

　　GB/T 19633-2005 Packaging of final sterilized medical devices

　　YY/T 0287-2003 medical device quality management system for regulatory requirements

　　YY/T 0313-1998 Medical polymer products packaging, marking, transportation and storage

　　YY/T 0316-2008 Medical Devices Application of Risk Management to Medical Devices

　　YY 0331-2006 Performance requirements and test methods for skimmed cotton gauze and skimmed cotton viscose blended gauze

　　YY 0466-2003 medical devices for medical device labeling, marking and providing information on the symbol

　　YY 0594-2006 General requirements for surgical gauze dressings

　　YY/T 0615.1-2007 Requirements for labeling “sterile” medical devices Part 1: Requirements for final sterilization of medical devices

　　<Pharmacopoeia of the People's Republic of China>

　　■ Clean room decontamination project linkage commissioning

　　The linkage commissioning is generally carried out in two stages, i.e. the air volume distribution stage and the linkage commissioning stage.

　　1、Air volume distribution：

　　The air volume distribution means that the air supply, return air, fresh air and exhaust air volume of each clean room are all adjusted to the design air volume according to the design requirements. Because a clean plant may have more than one air conditioning air supply system and exhaust system, or an air conditioning air supply system to bear the air supply of more than one clean room. Therefore, the air volume distribution and commissioning work is a large workload, long time, patient and meticulous work. Air volume distribution debugging work is also the focus of the entire commissioning work. The common method of air volume distribution debugging uses the standard air outlet method.

　　Standard air outlet method: a clean room may have several, dozens of air conditioning air supply and return air outlets. Because they are connected to each other, when adjusting the air volume of a certain air outlet air supply, the air volume of other air outlets will also change with it. Therefore, the standard air outlet method is used.

　　The so-called standard air outlet method is to find the most unfavorable air outlet (the air outlet with the smallest air supply) in all the air outlets before the air volume is distributed, with all the valves opened to the maximum, and take this outlet as the standard air outlet. Set up a monitoring instrument on the standard air outlet to test the air volume change of the standard air outlet at any time. Then adjust the air volume of all other air outlets. Because when adjusting the air volume of any one air outlet, it will affect the change of the air volume of the adjusted air outlet; therefore, when adjusting the air volume of any one air outlet, it is necessary to take the air volume of the standard air outlet as the reference air volume at that time, so that the air volume of all the adjusted air outlets will change synchronously with the change of the air volume of the standard air outlet.

　　When a clean air conditioning system is responsible for multiple clean room air conditioning, the commissioning should be carried out from the end of the clean room as a unit to the total trunk direction, and the relative relationship amount of air supply to each clean room should be adjusted first, and then, the total valve of the system should be used to adjust the air supply to each air outlet and each clean room to the real design air supply.

　　2、Commissioning of clean room purification project linkage

　　The linkage commissioning is carried out after the air volume adjustment and single machine commissioning. Linkage commissioning on the purified air conditioning system and all systems serving the purified air conditioning system, namely: cooling system (chiller, cooling tower, water pump and all accessories on the cooling system), heating system (boiler, water pump and all accessories on the heating system), power supply system (distribution box, inverter……) and automatic control system are all put into operation to assess the system's Comprehensive performance and linkage performance. If necessary, set a certain amount of load artificially in the clean room to assess whether the linkage of temperature and humidity probes, intermediate instruments and actuators is sensitive and coordinated; assess whether the temperature and humidity probes are accurate and whether the accuracy is qualified.