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. Pharmaceutical WorkerCompressed 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] PillsUnlike 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. Learn more about Compressor Contamination Sources at the AirCheck Academy™. PillsThe AirCheck Kit™ K8573NB & K8573NX models are designed to sample for particles, water and oil of your compressed air at the point of use. The K8573NX 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™ K8573NX 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™ K8573NB and K8573NX 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

Class Particles Water Oil
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 -
8 - - - - - - ≤ 5 -
9 - - - - - - ≤ 10 -
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.

Air & Gas Specifications referenced above may be viewed and/or purchased from: ANSI - American National Standards Institute

2011 ISPE Good Practice Guide - Process Gases, Table 7.1

Particles Water Oil
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
Air & Gas Specifications referenced above may be viewed and/or purchased from: ISPE - International Society of Pharmaceutical Engineering

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
(cfu/m3)
Microbiological Settling Plates Action Levelsc,d
(diam 90mm; cfu/4 hours)
100 5 3,520 e e
1,000 6 35,200 7 3
10,000 7 352,000 10 5
100,000 8 3,520,000 100 50
  1. All classifications based on data measured in the vicinity of exposed materials/articles during periods of activity.
  2. ISO 14644-1 designations provide uniform particle concentration values for cleanrooms in multiple industries. An ISO 5 particle concentration is equal to Class 100 and approximately equals EU Grade A.
  3. Values represent recommended levels of environmental quality. You may find it appropriate to establish alternate microbiological action levels due to the nature of the operation or method of analysis.
  4. The additional use of settling plates is optional.
  5. Samples from Class 100 (ISO 5) environments should normally yield no microbiological contaminants.

Recommended Limits for Microbial Contamination a

Grade Air Sample cfu/m3 Settle Plates
(diameter 90mm)
cfu/4 hours b
Contact Plates
(diameter 55mm) cfu/plate
Glove Print
5 fingers
cfu/glove
A < 1 < 1 < 1 < 1
B 10 5 5 5
C 100 50 25 -
D 200 100 50 -
  1. These are average values.
  2. Individual settle plates may be exposed for less than 4 hours.
Air & Gas Specifications referenced above may be viewed and/or purchased from: ANSI - American National Standards Institute

Videos

To see manufacturing and ISO compressed air testing, click here to watch Videos on Air Testing with AirCheck Kit™ K8573

Process Air Industries We Serve:

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