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ISPE Good Practice Guide Compressed Air Specifications

Trace Analytics, LLC specializes in the analysis of thousands of compressed air & gas samples each year. Many of our customers have established their own criteria by 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 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. We have many more air & gas specifications in our database. If you need a custom specification, Contact Us with your requirements.

2011 ISPE Good Practice Guide - Process Gases, Table 7.1

ParticlesWaterOil
By Particle Size
(maximum number of particles per m3)
By MassAerosols or Vapor Pressure DewpointLiquidHydrocarbons
0.10 µm < d ≤ 0.5 µm0.5 µm < d ≤ 1.0 µm1.0 µm < d ≤ 5.0 µmmg/m3°C°Fg/m3mg/m3
Viable and Non-Viable Count Typically equal to the at rest condition of the area served≤ -40≤ -40-≤ 0.5
Microbial CountOther Chemical Impurities
Non-Sterile ApplicationsSterile Applications(Only as Applicable) Based on the generation technology and/or USP/EU Monograph
Guideline limits to be established based on product bioburden limits. Typical level NMT 5 cfu/m3As 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)Gas Purity
Applicable for inert gases such as Nitrogen, as per USP/EU Monograph
Air & Gas Specifications referenced above may be viewed and/or purchased from: ISPE - International Society of Pharmaceutical Engineering