Professional Documents
Culture Documents
ISPE Good Practice Guide and Compressed Air
ISPE Good Practice Guide and Compressed Air
Compressed air, also referred to as process gas, is used in many capacities in the
pharmaceutical industry. Regular quality control testing plays an important role in
the safety of your products. The ISPE Good Practice Guide for process gases asserts
that compressed air usage in pharmaceutical manufacturing should be free from
contaminants and routinely maintained and tested. Although there are not specific
limits set, the ISPE Good Practice Guide does provide helpful suggestions,
recommendations and guidelines for adequate system design, appropriate controls
and routine maintenance of compressed air systems. Analytical and risk-based
testing methods are recommended for all pharmaceutical process gases and
compressed air systems (ISPE, 2011).
When performing a risk analysis for a pharmaceutical compressed air system, you’ll
need to determine the potential contaminants, identify the sampling points, and
determine the appropriate process parameters for each control sample point.
Systemic risks can include piping, storage, point of use, filtration, and dryers. These
are all critical aspects that should be carefully identified and documented according
to ISPE Good Practice Guide (2011). Each facility will have unique risks based on
location, environmental factors, equipment, operations and system age. Each piece
of the system that comes into contact with the compressed air should be
considered.
There are a variety of ways that a compressed air system can be set up, but most
systems include a compressor, filtration mechanisms, air receivers, dryers and
controls. Each of these components will come with manufacturer recommendations
for care and maintenance. In order to ensure the systems are working properly, take
care to follow these instructions closely. The ISPE Good Practice Guide (2016)
states that sample points should be regularly maintained and should not introduce a
risk of contamination to the system. Completing a risk assessment can help account
for each of these factors and determine the appropriate purity classes for your
compressed air.
Evaluate what in your system might go wrong, what probably will go wrong, and
the potential consequences of these risks (ISPE, 2011). Part of an effective risk
assessment is to determine what can be done to eliminate these risks and protect the
end user.
According to ISPE Good Practice Guide (2016), compressed air can be used to dry
a product, spray paint a product, move a product, or could even be included as a
component or ingredient. Analyzing your product’s relationship with compressed air
will allow your facility to determine appropriate purity class levels.
Particles: Depending on the purity class that your facility is trying to achieve, a few
different methods are available when testing for particulates. In order to achieve
Purity Classes 0, 1 or 2, a laser particle counter should be used. If Purity Classes 3-
6 are required, then sample collection by filter will be sufficient.
Water Vapor: Facilities can test for water vapor contamination using chemical
reactor tubes. It is important to follow the manufacturer’s recommendations when
testing with this media, but overall, it is a simple and inexpensive way to ensure your
compressed air is free from moisture.
Oil Aerosol: As with particles, oil aerosol can be collected with a filter cassette
membrane. It is important to ensure that oil aerosol does not collect and pool in the
compressor system.
Oil Vapor: Similar to water vapor, oil vapor can be tested using a detector tube.
Charcoal tubes are best for sampling for oil vapor.
Ideally, sampling locations should be after the final filter so all the particles, water,
oil, and microorganisms have been removed. This sample will be most
representative of the air coming into contact with your products and should meet
your facility’s specifications. The end of the distribution line is another important
point for sampling. Should the piping release contamination throughout the line, air
quality may be much worse at the end of the distribution line. All critical points of
use should also be sampled to ensure proper air quality, as they have direct impact
on product quality.
Occasionally, manufacturers fail audits and tests not because of the actual air quality,
but because of a lack of regular maintenance, or ineffective materials. Troubleshoot
your system using this informational webinar. Regular compressed air analyses will
help to provide historical data and ensure that your system maintains a satisfactory
level of quality over time.
ISPE Good Practice Guide recognizes that compressed air quality testing approaches
may vary between pharmaceutical companies, but it is critical that these variations
exist based on the specific products, system, and risks.
The following chart is a helpful indication of when to test for what contaminants.
Another important aspect of a quality plan is to work with a third party, accredited
laboratory like Trace Analytics. Offering a variety of specifications, Trace can help
ensure that your air is free from contaminants and safe to use on your products.
Ensuring the quality of your pharmaceutical process air is simple and effective when
using the ISPE Good Practice Guide along with your facility’s risk assessment.
References:
2. Larrabee, Chad, and Nicholas Haycocks. ISPE Good Practice Guide: Process
Gases. ISPE, 2011.