Verification of Compressed Air System in Medical Device Cleanroom

NegotiableUpdate on 01/09

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Overview

Medical Device Cleanroom Compressed Air System Validation Compressed Air Detection - Compressed Gas Oil Water Testing Compressed Gas Detection Oil Water, (Dew Point Testing), Solid Particles (Dust Particles), Microorganisms (Floating Bacteria Testing), Suzhou Yikang Environmental Testing uses international brand testing equipment to provide you with accurate testing results

Product Details

Verification of Compressed Air System in Medical Device Cleanroom

1、 Compressed air for medical devicesDQTheIQTheOQThePQ

Design confirmation（DQ）Verify whether the system design complies with regulations and process requirements
Installation confirmation（IQ）Verify that the equipment installation meets the design requirements (such as pipeline welding quality, filter model, pressure gauge calibration status).
Operation confirmation（OQ）Test the stability of the system under different operating conditions (such as pressure fluctuation range, dew point compliance, filter pressure difference).
Performance Confirmation（PQ）Under continuous production conditions, detect the indicators of particles, microorganisms, oil content, and moisture at the gas point

Verification of Compressed Air System in Medical Device Cleanroom Compressed air detection-Compressed gas oil-water testCompressed gas detection Oil and water, dew point testing, solid particulate matter (dust particles), microorganisms (planktonic bacteria testing), Suzhou Yikang Environmental Testing uses international brand testing equipment to provide you with accurate testing results.

serial number	Detect product category	Product or parameter name	According to the standard of the subject matter(method)serial number	Based on the standard(method)name
1	compressed gas	humidity	GB/T13277.3-2015	Compressed air3Part: Humidity measurement methods
2	compressed air	oil content	GB/T 13277.2-2015	Compressed air2Part: Measurement method for suspended oil content
3	compressed gas	solid particles	GB/T 13277.4-2015	Compressed air4Part: Solid particle measurement methods
4	compressed air	Active microorganisms	GB/T 13277.7-2021	Compressed air7Part: Methods for measuring the content of active microorganisms

Compressed air water detection

Oil content and testing—Using GermanyDrager(Delger)ALPHACompressed air quality tester, capable of detecting3~15Compressed gas with a pressure range of kilograms, detection time is only5minute.

The side wall of the moisture detection tube is marked with3Column scale and corresponding detection time, observe the numerical scale corresponding to the detection time during detection, and observe the changes in the detection value within the corresponding time

(i.e. color changing display) should not exceed the maximum limit of the column value

Measurement point moisture content={measured value/Detection Time} *Scale standard time

level	pressure dew point/ °C
0	The ratio level established by the device user or manufacturer 1 higher requirements
1	≤-70
2	≤-40
3	≤—20
4	≤+3
5	≤+7
6	≤+10

compressed airWater content（dew point）Testing

医疗器械洁净厂房压缩空气系统验证

Compressed air oil detection

Moisture detection—Using GermanyDrager(Delger)ALPHACompressed air quality tester, capable of detecting3~15Compressed gas with a pressure range of kilograms, detection time is only5minute.

Pull out the oil detection box and observe

And compare with the standard view to determine the detection value.

Reference diagram for compressed air oil detection

医疗器械洁净厂房压缩空气系统验证

level	Total oil content (liquid oil, suspended oil, oil vapor)/ (mg/m3)
0	The ratio level established by the device user or manufacturer 1 higher requirements
1	≤0.01
2	≤0.1
3	≤1
4	≤5
Note: The total oil content is shown in the table 1 The value in the state.