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E-mail
changliu006@126.com
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Phone
18915420690
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Address
Room 402, Building 117, Shuangyin International, No. 1388 Dongfang Avenue, Wuzhong District, Suzhou
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Suzhou Yikang Environmental Testing Co., Ltd
Clean room testing - sterile medical equipment production clean area
NegotiableUpdate on 05/18
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Overview
Description: Clean Room Testing - Aseptic Medical Device Production Clean Area, YY 0033-2000 Aseptic Medical Device Production Management Specification
Product Details
| Test Item | Applicable subjects | Testing Standard |
| wind speed air volume/Ventilation rate detection Differential pressure detection Cleanliness testing (suspended particle count)) Temperature detection Relative humidity detection Noise detection Illumination detection Microbial detection (planktonic bacteria, settling bacteria) | Production of sterile medical equipment (clean room) | Code for Construction and Acceptance of CleanroomsGB50591-2010 Test Method for Suspended Particles in Cleanrooms (Areas) of the Pharmaceutical IndustryGB/T16292-2010 Testing Method for Floating Bacteria in Cleanrooms (Areas) of the Pharmaceutical IndustryGB/T16293-2010 Test Method for Settling Bacteria in Cleanrooms (Areas) of the Pharmaceutical IndustryGB/T16294-2010 Technical Specifications for Disinfection in Medical InstitutionsWS/T367-2012 Production and Management Specification for Aseptic Medical DevicesYY 0033-2000 |
| YY 0033-2000Standard for Production and Management of Aseptic Medical Devices Appendix for Environmental Requirements and Monitoring of Aseptic Medical Equipment Cleanrooms (Areas)3 | ||||||||
| technical indicators | monitoring method | |||||||
| monitoring project | 100level | 10 000level | 100000level | 300000level | JGJ 71—1990abolish The number of the "New Cleanroom and Construction Acceptance Specification" isGB50591-2010 | Monitoring frequency | ||
| temperature,℃ | (When there are no special requirements)18-28 | 1Number/Class | ||||||
| Relative humidity,% | 45—65 | 1Number/Class | ||||||
| wind speedm／s | laminar flow ≥0.4 Vertical layer vapor ≥0.3 | —— | —— | —— | 1time/moon | |||
| Ventilation rate, times/h | —— | ≥20 | ≥15 | ≥12 | 1Next/Month | |||
| Static pressure difference,Pa | Different levels of clean rooms (zones) and clean rooms (zones) Between non clean rooms (areas) ≥5 | 1Next/Month | ||||||
| Clean room (area) and outdoor atmosphere ≥10 | ||||||||
| Dust count | ≥0.5 um | ≤3500 | ≤350 000 | ≤3500 000 | ≤10 600 000 | GB/TI6292--1996abolish GB/TI6292—2010current | 1Next/Season | |
| ≥5 pm | 0 | ≤2 000 | ≤20 000 | ≤60 000 | ||||
| Number of planktonic bacteria, per unitm3 | ≤5 | lOO | 500 | Not making regulations | GB/T16293--1996abolish GB/TI6292—2010current | 1Next/Season | ||
| Number of sedimentation bacteria, per dish 0.5h | ≤l | ≤3 | ≤10 | ≤l5 | GB/T16294--1996abolish GB/T16294--2010current | 1Next/Week | ||
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