Supplement Production and SQF Certification

Since the adoption of compressed air purity testing by the Safe Quality Food Institute (SQF) in mid 2012, food manufacturers renewing their SQF certification have been required to test the compressed air they use directly and indirectly in the production process. In some cases we are finding SQF requiring compressed air testing of pneumatic exhaust that may come into contact with the product. All of this is in an effort to maintain the integrity of the food supply we all use. According to the Federal Drug Administration (FDA), dietary supplements fall under the category of food for quality purposes. Supplement manufacturers requesting SQF certification and using compressed air in their production process are now required to test the purity of production compressed air and test it regularly.

Across the world, almost daily, we see contamination in the food supply that sickens people, results in recalls and in extreme situations halts manufacturing production. To learn more about contamination that can occur from compressed air, visit our web page on Compressor Contamination Sources. SQF and other entities put so many regulations in place in an effort to stop food contamination. According to the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement or dietary ingredient manufacturer is responsible for ensuring that dietary supplements are safe. This puts all of the responsibility on the shoulders of the supplement manufacturer.

Trace Analytics has developed a series of AirCheck Kits™ that allow the user to obtain compressed air and gas samples specifically for analysis. Our A2LA Accredited Laboratory can provide analysis per ISO 8573 or your custom specifications for contaminants like particles, water, oil, gases and microbes.

We are happy to walk you through the process of understanding the new SQF certification requirement on compressed air testing, setting up a monitoring program and understanding the results of your analyses. In addition we can set you up with automatic reminders to let you know when it is time to test again and in some cases find an AirCheck™ Distributor to come out and take the samples for you. Contact Us today to speak with a member of our AirCheck Team of Experts™ about your production process and air testing needs.

Supplements Compressed Air & Gas Testing Specifications

Trace Analytics, LLC is an A2LA Accredited Laboratory in compliance with ISO 17025 as required by BRC and SQF Code, Edition 7, Section 2.5.6. We can test to a wide variety of specifications. Some example specs commonly used in Supplements 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


To see SQF compressed air testing, click here to watch Videos on Air Testing with AirCheck Kit™ K8573.

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