Anqing Medical GastroscopePurification project
Project Name：Shanghai Anqing Medical Equipment Co.
Project content：Thousand, ten thousand, one hundred thousand class purification project
Industry Category：Disposable medical gastroscope
■Introduction of Anqing
Ltd. was founded on July 18, 2014, is a medical technology company dedicated to the research, development and production of medical devices, especially visual medical devices, located in the Zhangjiang Hi-Tech Park in Pudong New Area, Shanghai, mainly based on CMOS high-definition image endoscope medical products, especially in the ultra-fine endoscope with world-leading technology, professional medical image processing Plus a wealth of experience in medical product design to provide medical workers with accurate and efficient digital imaging diagnostic solutions.
Shanghai Anqing Medical Equipment Co., Ltd., medical equipment equipped with clean room is built by Shanghai Lixing, clean grade thousand, ten thousand, one hundred thousand, temperature: 18-26 ℃ humidity 45-65%; construction area of 4400 square meters, the purification project built by Shanghai Lixing, 100,000 clean production workshop to establish automated standard production lines in line with GMP certification requirements.
■ Design basis
100,000 class clean room standards, 100,000 class clean room standards are：
Maximum permissible number of dust particles (per cubic meter).
The number of particles greater than or equal to 0.5 microns cannot exceed 3500000, and the number of particles greater than or equal to 5 microns cannot exceed 20000.
Maximum permissible number of microorganisms.
Class 100,000 clean room standard is that the number of floating bacteria cannot exceed 500 per cubic meter.
The number of settling bacteria should not exceed 10 per Petri dish.
Pressure difference: the same cleanliness level of the clean workshop pressure difference to maintain consistent, for different cleanliness level of the adjacent clean workshop between the pressure difference to ≥ 5Pa, clean workshop and non-clean workshop to ≥ 10Pa.
Class 100,000 clean room on temperature, humidity no special requirements, to wear clean clothes do not produce a sense of comfort, the temperature is generally controlled in the autumn and winter 20 ~ 22 ℃; spring and summer 24 ~ 26 ℃; fluctuations ± 2 ℃. The air humidity of the clean room in autumn and winter is controlled at 30-50%, and the air humidity of the clean room in spring and summer is controlled at 50-70%.
Power distribution: clean room (area) of the main production land general illumination value is appropriate ≥ 300Lx; auxiliary studio, personnel clean and material clean with room, airlock room, aisle, etc. illumination value is appropriate for 200 ~ 300Lx.
1. During dynamic testing, the noise level in the 10,000-grade clean room shall not exceed 70 decibels A.
2. the noise level of the 10,000-class chaotic flow clean room cannot exceed 60 decibels A during static testing.
The main air supply methods used in class 100,000 clean rooms.
1、Partial orifice plate roof air supply.
2, with diffuser plate high efficiency air filter roof air supply.
3, the upper side wall air supply and other three air supply methods.
The main methods of return air used in class 100,000 clean rooms.
1. Arrangement of return air opening at the lower part of the single side wall.
2、When the aisle return air is used, the return air outlet is evenly arranged in the aisle or the return air outlet is concentrated at the end of the aisle.
Air velocity of air supply outlet m/s：
1、Orifice plate orifice 3~5；
2、Side air supply outlet：
(1) Adherent jet 2~5；
(2) non-adherent jet with the lower side wall return air 1.5 ~ 2.5, the lower side wall return air 1.0 ~ 1.5.
Wind speed at return air outlet (m/s)：
1、The clean room return air outlet is not more than 2；
2. The return air outlet in the aisle is not more than 4.