ISPE Good Practice Guide Air & Gas Specifications
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|
|By Particle Size
(maximum number of particles per m3)
|By Mass||Aerosols or Vapor Pressure Dewpoint||Liquid||Hydrocarbons|
|0.10 µm < d ≤ 0.5 µm||0.5 µm < d ≤ 1.0 µm||1.0 µm < d ≤ 5.0 µm||mg/m3||°C||°F||g/m3||mg/m3|
|Viable and Non-Viable Count Typically equal to the at rest condition of the area served||≤ -40||≤ -40||-||≤ 0.5|
|MICROBIAL COUNT||OTHER CHEMICAL IMPURITIES|
|Non-Sterile Applications||Sterile 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/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)||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
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