Compressed Air Purity Checks for Pharmaceutical and Medical Facilities

Specifications

In the pharmaceutical industry, the adoption of CGA Grade D as the standard for compressed instrument air is common. However, this specification often lacks the detail necessary to fully safeguard against potential issues. While air sampled and tested may meet these standards, hidden contaminants or system failures can still cause significant problems. This guide outlines key considerations to accurately assess the condition of your compressed air system.

Sampling

Effective air sampling follows two fundamental principles:

1. Sampling Methodology
Sampling must be conducted in a manner that uncovers solid debris (such as desiccant dust, charcoal particles, and metallic shavings) and oil accumulation within the piping. This requires sampling at high flow rates—ranging from 10 to 20 SCFM or greater. High flow rates simulate real-world operating conditions and enable the detection of debris and oil that would otherwise adhere to piping walls. Many sampling kits fail to achieve these flow rates, often confusing high pressure with sufficient flow. Our kits are specifically designed to operate at reduced pressure while maintaining high flow rates, ensuring accurate results.

2. Adequate Sample Volume
Always collect a statistically significant air sample to provide sufficient material for comprehensive laboratory analysis. Kits with small sample vials (holding approximately 30 cc of unpressurized air) are insufficient for detailed testing and restrict the ability to reanalyze or confirm results if issues arise.

Analysis

Pharmaceutical and medical facilities require precise and sensitive laboratory techniques to evaluate compressed air purity. These methods include:

• Gas Chromatography (GC) and Gas Chromatography-Mass Spectrometry (GC-MS): Industry-standard for identifying and quantifying contaminants with high specificity.
• Infrared Absorption Spectrometry (IR): While beneficial for certain applications, IR lacks the universal applicability and specificity of GC techniques.

Key contaminants of concern include:

• Moisture: Best measured with a dew point meter capable of readings as low as -78 ºC. Our methodology includes periodic checks using Dräger tubes to ensure sensor accuracy and reliability.
• Non-Volatile Hydrocarbons (Compressor Oil): Often removed by physical filters, oil mist can bypass filtration during equipment failure. Our membrane filter technique detects oil at ultra-low concentrations (0.01 mg/m³) and identifies particulate contamination simultaneously.

The ACI Universal Air Sampling Kit: Model RD2-137

Designed to meet the rigorous demands of pharmaceutical and medical applications, our RD2-137 air sampling kit offers unparalleled performance and flexibility:

1. High Flow Sampling: Safely samples air at flow rates ranging from 2 to over 20 SCFM, featuring dual failsafe components rated for pressures up to 3400 psi.
2. Moisture Detection: Integrated Dräger tube holder accurately measures moisture levels down to 4 ppmv (-70ºC dew point) in under 10 minutes.
3. Oil and Particulate Filtration: Equipped with a 0.7-micron membrane depth filter, the kit detects oil mist and particulates at levels as low as 0.01 mg/m³ by analyzing up to 4 cubic meters of air.
4. Optional Particle Counting: Supports a 0.45-micron filter for microscopic particle counting, ideal for applications requiring detailed particulate analysis.

Our Testing Standards

We provide comprehensive testing and reporting based on precise methods and detailed specifications, tailored for pharmaceutical-grade air.

Compressed Processing Air Testing Includes:

Why Choose Analytical Chemists, Inc.?

With decades of expertise and industry-leading technology, Analytical Chemists, Inc. provides pharmaceutical and medical facilities with the most reliable and precise air purity testing available. Our patented solutions and laboratory techniques ensure your compressed air systems meet the highest standards, protecting both your operations and end products.

Contact us today to learn more about how we can support your air quality needs.