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ISPE Good Good Practice Guide Compressed Air Specifi Specifi cations - Compressed Compr essed Air Testing - Trace Analytics AnalyticsCompressed Compressed Air Testing Testing - Trace Analytics Analytics
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ISPE ISPE Good Practice Guide Guide Compressed Air Specications Trace Trac e Analytics, LLC specializes in the a nalysis of thousands of compressed air & gas samples each year. Many of our customers have established their own own criteria by monitoring monitoring the performance of the system over a given time period, reviewing literature/specifications, evaluating equipment parameters, and determining company objectives. Whether you are establishing a management plan or testing to comply with a given specification, our knowledgeable staff will be glad to assist you. Our scientifically designed compressed air testing kits make kits make collection a simple task. Keep the small, portable kit, and return the lightweight sample via the shipping method of your choice. The ISPE Good Practice Guide for Process Gases is shown below. If the specification you need is not shown, please Contact Us. Us. We have many more air & gas specifications in our database. If you need a custom specification, Contact Us Us with your requirements.
2011 ISPE Good Practice Guide - Process Gases, Table 7.1 Par ticles
Water
By Particle Size
By Mas s
(maximum number of particles per m 3 )
0 .1 .10 - 0 .5 .5 mic ro ro ns ns
0 .5 .5 - 1 .0 .0 m ic ro ro ns ns
1 .0 .0 - 5 .0 .0 mic ro ron s
mg /m /m3
Viable and Non-Viable Count Typically equal to the at rest condition of the area served
Microbial Count
Oil
Aeros ols or Vapor Pres sur e Dewpoint
Liquid
Hydr oc arbons
°C
°F
g/m3
mg/m3
≤ -40
≤ -40
-
≤ 0.5
Other Chemical Impur ities
NonNo n-S Ste teri rille App ppllica cati tions o ns
Ste teri rille App ppllica cati tions o ns
Guideline limits to be established based on product bioburden limits. Typical level NMT 5 cfu/m3
As per viable particle requirements for Grade area where the product is exposed to the compressed gas (e.g., Grade A, Grade A/B, Grade B or Grade C)
(Only (On ly as App ppllica cabl ble) e ) Bas ased ed on th the e ge gene nera rati tion o n te tech chno nollog ogy y an and/ d/or or US USP P/E /EU U Mo Mono nogr grap aph h
Gas Purity Applicable Appli cable for inert gases such as Nitrogen, as per USP/E USP/EU U Monograph
Air & Gas Specificati Specifications ons r eferenced above may be viewed and/or pur chased from: ISPE - International Society of Pharmaceutical Engineering Engineering
Other Compressed Air & Gas Specications: Airline Respirator Compressed Air Specifications ANSI / ISA Compressed Air Specifications BCAS Food Grade Air Purity Compressed Air Specifications Commercial / Government Diving Compressed Air Specifications ISO 8573-1:2010 Compressed Air Specifications ⇒ ISPE Good Practice Guide Compressed Air Specifications Medical Gas Compressed Air Specifications Microbial / Cleanroom Compressed Air Classifications Pure Gas Air Quality Specifications SCBA Compressed Air Specifications SCUBA / Sport Diving Compressed Air Specifications
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ISPE Good Practice Guide Compressed Air Specifi cations - Compressed Air Testing - Trace AnalyticsCompressed Air Testing - Trace Analytics
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