Process Gases in the Pharmaceutical Industry
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.
Primary sources of contamination in a compressed air supply include the ambient intake air and the compressor itself.
At any given time the atmospheric air feeding the compressor inlet can have contaminants such as solid particles (dirt, sand, soot, metal oxides, salt crystals), water vapor, oil vapor, and microorganisms. Careful consideration should be given to the placement of the compressor intake to avoid these contaminants as much as possible. The intake filter as a first defense should be routinely replaced according to the manufacturer’s guidelines.
The compressor, if oil lubricated, can also add oil in the form of liquid, aerosol, or vapor. Any compressor that is improperly maintained can be a source of contamination.
Other sources of contamination include the system piping and air storage receivers.
New piping should be tested to assure that it is has been properly purged of potential contaminants such as particulates and solders or glues used during installation. Older piping can have an accumulation of water, rust and oil. When connecting new piping to an older piping distribution system, the jarring of the old piping can cause particulates (such as rust, pipe scale, dirt, metal oxides, etc.) to be loosened and introduced into the new piping.
Storage receivers with excess water (vapor, liquid, or a mixture of oil and water) can become a breeding ground for micro-organisms.
Potential air quality problems can arise from misuse, mishandling, inattention to maintenance, and human error.
A periodic air test program can provide critical information to monitor air quality and help prevent contamination of the product. The sampling plan should include sampling points, number of samples, and the frequency of sampling for each unit operation and attribute. The number of samples should be adequate to provide sufficient statistical confidence of quality. [cGMP Guidance for Industry Process Validation: General Principles and Practices.]
Trace’s AirCheck Kit™, 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 Kit™ 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 Kit™ K8573, Contact Us by email or phone 1-800-247-1024 x3.
Process Air Industries We Serve:
Electronics
Food Industry
Medical Device
Pharmaceutical
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