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 | |||||||||
| 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 | |||||
| 0.1 µm < d ≤ 0.5 µm | 0.5 µ m< d ≤ 1.0 µm | 1.0 µm < d ≤ 5.0 µm | 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. | |||||||||
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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 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 | ||||||||
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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 | 1 e | 1 e | |
| 1,000 | 6 | 35,200 | 7 | 3 | |
| 10,000 | 7 | 352,000 | 10 | 5 | |
| 100,000 | 8 | 3,520,000 | 100 | 50 | |
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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 | - | |
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