Pharmaceutical Process Air & Gas
Compressed 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]
Unlike 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, oxygen, argon, and carbon dioxide that come into direct contact with the product is vital to assuring the quality and safety of the product.
Click this link to learn more about Compressor Contamination Sources.
Trace's AirCheck KitTM, Model K8573 is designed to obtain samples from points of use. Sampling includes Particles, Water, Oil Aerosol and Vapor, and optional gases. ISO 8573-1 is one of the few standards available for non-breathing air that addresses a wide variety of manufacturing needs including pharmaceutical. The AirCheck KitTM can also be used to sample the same parameters for pure gases such as oxygen, nitrogen, argon, and carbon dioxide.
We offer baseline testing when you are unsure what Purity Classes your air system can meet, any given Purity Classes you select, or you can provide your own custom specifications. Other specifications that are available include CGA, USP, NFPA, ANSI, and others.
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 KitTM K8573, Contact Us by email or
phone 1-800-247-1024 x3.