Pharmaceutical Process Air & Gas
Testing and monitoring of compressed air and other process gases such nitrogen, oxygen, argon, and carbon dioxide that come into direct contact with pharmaceutical products is vital to assuring the quality and safety of those products.
Compressed air is a Critical Process Parameter (CPP) whose variability has an impact on the Critical Quality Attribute (CQA) and therefore should be monitored or controlled to ensure the process produces the desired quality. [ICH Q8 (R2) II 4.0] During commercial manufacturing, a well-defined system for process performance and product quality monitoring should be applied to assure performance within a state of control and to identify improvement areas. [ICH Q10 3.2.1] Quality risk management should include facilities, equipment, and utilities. [ICH Q9]
Unlike the food industry, the pharmaceutical industry does not have a clear-cut guideline or regulation that specifically addresses compressed air quality requirements, testing frequency, or number of samples. The individual manufacturer is responsible for assessing the risk and affect that a contaminated compressed air supply could have on the final product. An important international standard, ISO 8573-1, provides a variety of Purity Classes that can be incorporated into a robust quality assurance plan for this critical utility. Testing and monitoring of compressed air and other process gases such nitrogen and oxygen that come into direct contact with the product is vital to assuring the quality and safety of the product.
The AirCheck✓ Kit™ K810 & K811 models are designed to sample for particles, water and oil of your compressed air at the point of use. The K811 model also includes the capability to sample for a variety of gases. Kits can be purchased or rented. Your personnel can obtain the air samples using our detailed AirCheck✓™ Academy How-To Sampling Videos and thorough Sampling Instructions included with each kit. We also have a wide network of independent AirCheck✓ Service™ Distributors who can provide air sampling services – contact us to find one near you. Samples are easily shipped to Trace’s A2LA accredited laboratory for analysis and comparison to ISO 8573-1 Purity Classes, an ISO 8573 baseline comparison if you are unsure of which Purity Classes to select, or your own custom air specifications.
The AirCheck✓ Kit™ K811 can also be used to sample gas purity as well as particles, water, and oil in pure gases such as oxygen and nitrogen used in manufacturing processes.
Trace Analytics is an A2LA accredited laboratory established in 1989. We do one thing: test compressed air! We have a great team of experts ready to answer your questions and help you get started with your air quality assurance program.
To receive more information about process air and pure gas testing for the pharmaceutical industry, ISO 8573-1 and our baseline testing with AirCheck✓ Kit™ K810 and K811 models, Contact Us or phone 1-800-247-1024 x3.
Pharmaceutical Industry Compressed Air & Gas Testing Specifications
Trace Analytics, LLC can test to a wide variety of specifications. Some example specs commonly used in Pharmaceutical Industry are shown below:
ISO 8573-1:2010 Compressed Air Contaminants and Purity Classes
|By Particle Size
(maximum number of particles per m3) See Note 2
|By Mass||Vapor Pressure Dewpoint||Liquid||Liquid, Aerosol, & Vapor
See Note 1
|0.10 – 0.5 microns||0.5 – 1.0 microns||1.0 – 5.0 microns||mg/m3||°C||°F||g/m3||mg/m3|
|0||As specified by the equipment user or supplier and more stringent than class 1|
|1||≤ 20,000||≤ 400||≤ 10||-||≤ -70||≤ -94||-||≤ 0.01|
|2||≤ 400,000||≤ 6,000||≤ 100||-||≤ -40||≤ -40||-||≤ 0.1|
|3||-||≤ 90,000||≤ 1,000||-||≤ -20||≤ - 4||-||≤ 1|
|4||-||-||≤ 10,000||-||≤ +3||≤ +37||-||≤ 5|
|5||-||-||≤ 100,000||-||≤ +7||≤ +45||-||-|
|6||-||-||-||0 – ≤ 5||≤ +10||≤ +50||-||-|
|7||-||-||-||5 – ≤ 10||-||-||≤ 0.5||-|
|X||-||-||-||> 10||-||-||> 10||> 5|
|Microbiological Contaminants||Other Gaseous Contaminants|
|No purity classes are identified||No purity classes are identified
Gases mentioned are: CO, CO2, SO2, NOX, Hydrocarbons in the range of C1 to C5
Note 1: ISO 8573 Oil includes aerosol, vapor in the range of C6+, and liquid oil. Liquid oil is typically sampled when wall flow is present, contamination is suspected, or results are greater than 5 mg/m3. Trace can provide a separate kit for liquid oil testing.
Note 2: For Particle Class 0, 1, & 2 (0.1 - 0.5 µ range only), a laser particle counter with a high-pressure diffuser is required. Rental of this equipment is available on a reservation basis. Contact us for details. To qualify for Particle Classes 0 through 5, there can be no particles greater than 5µ present.
In some cases, Trace uses alternative sampling techniques or analytical methods to those specified in ISO 8573, for details see Smith White Paper, 2012.
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 - 0.5 microns||0.5 - 1.0 microns||1.0 - 5.0 microns||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|
Cleanroom Classifications a
|Clean Area Classification
(0.5 µm particles/ft3)
|ISO Designation b||≥0.5 µm particles/m3||Microbiological Active Air Action Levels c
|Microbiological Settling Plates Action Levelsc,d
(diam 90mm; cfu/4 hours)
|100||5||3,520||1 e||1 e|
Recommended Limits for Microbial Contamination a
|Grade||Air Sample cfu/m3||Settle Plates
cfu/4 hours b
(diameter 55mm) cfu/plate
|A||< 1||< 1||< 1||< 1|
To see manufacturing and ISO compressed air testing, click here to watch Videos on Air Testing with AirCheck✓ Kit™ K810
Process Air Industries We Serve:
- BRC Compressed Air Monitoring
- Choosing a Spec
- Food Grade Air in Manufacturing
- Food Packaging Compressed Air Quality
- Medical Device
- Pet Food
- Pharmaceutical Industry
- SQF Air Purity
- Supplement Production and SQF Certification