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Pharmaceutical Process Air & Gas

Trace Analytics, LLC – the leading compressed air testing laboratory since 1989

Pharmaceutical Process Air & Gas

Compressed air is a critical utility used widely throughout pharmaceutical manufacturing processes and it is used both directly and indirectly with pharmaceutical products. Regular testing of compressed air systems and other process gases that come into contact with pharmaceutical products is critical to ensuring the quality and integrity of the product.

At Trace Analytics, our team of experts is dedicated to providing safe, clean air at the highest quality standards while simultaneously offering guidance for pharmaceutical manufacturers when there is not clear testing criterion.

What We Offer

We offer custom testing specifications tailored to meet individual testing needs as well as guidance for manufacturers navigating testing requirements. Our reliable, accurate, and easy-to-use testing kits comply with ISO 8573-1:2010 sampling and analytical requirements, providing assurance to manufacturers about the quality of their final product.

Pharmaceutical Industry Compressed Air & Gas Testing Specifications – Pharmaceutical Industry

In the absence of a specified standard, pharmaceutical manufacturers are recommended to rely on the International Organization for Standardization (ISO) 8573-1:2010 air standards in addition to a regular air testing schedule to maintain the appropriate air purities. The ISO 8573 Purity Class chosen by a manufacturing facility is dependent upon the individual manufacturer’s use of the compressed air and its contact with the pharmaceutical product. The facility should begin by performing a Hazard Analysis, which will help the manufacturer identify potential compressed air hazards, assess the existing control measures, and ultimately determine if extra controls are needed.

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

ClassParticlesWaterOil
By Particle Size
(maximum number of particles per m3) See Note 2
By MassVapor Pressure DewpointLiquidLiquid, Aerosol, & Vapor
See Note 1
0.1 µm < d ≤ 0.5 µm0.5 µ m< d ≤ 1.0 µm1.0 µm < d ≤ 5.0 µmmg/m3°C°Fg/m3mg/m3
0As 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 ContaminantsOther Gaseous Contaminants
 No purity classes are identifiedNo 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

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

Cleanroom Classifications a

Clean Area Classification
(0.5 µm particles/ft3)
ISO Designation b≥0.5 µm particles/m3Microbiological Active Air Action Levels c
(cfu/m3)
Microbiological Settling Plates Action Levelsc,d
(diam 90mm; cfu/4 hours)
10053,520ee
1,000635,20073
10,0007352,000105
100,00083,520,00010050
  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

GradeAir Sample cfu/m3Settle Plates
(diameter 90mm)
cfu/4 hours b
Contact Plates
(diameter 55mm) cfu/plate
Glove Print
5 fingers
cfu/glove
A< 1< 1< 1< 1
B10555
C1005025-
D20010050-
  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