Elements of a comprehensive environmental monitoring program, including compressed gas contamination monitoring
Control of the environment where pharmaceutical and cosmetic products are manufactured is a key element of Good Manufacturing Practices (GMP). Compressed gas contamination monitoring is just one element in maintaining control of a manufacturing cleanroom, isolator, or Restricted-Access Barrier Systems (RABS). The following requirements are dictated by ISO14644, 21 CFR 11 & EU GMP Annex 1 and generally accepted cGMP’s worldwide. These are considered the highest level of manufacturing environmental control across all industries and countries and are the gold standard for a comprehensive contamination control program. This is an excellent monitoring plan by which to model a lesser, or even un-regulated manufacturing site as the protections provided by this level of environmental control will check and balance each other to provide optimal facility control.
The first table below controls for non viable particulate in the clean environment, including compressed gases. The standards governing this form of particulate monitoring include:
- Total room/enclosure particulate levels
- Differential pressures between clean areas
- Directional air flow
- Temperature and humidity
Because of how these factors impact each other, controlling for them together will set the foundation for overall environmental control. Maintaining awareness of the levels of each component allows a cleanroom manager to anticipate and correct problems before the whole environment is compromised.
This second table controls for microbial organisms in the clean environment and compressed gases. The standards governing this form of particulate include viable organism counts:
- in room/enclosure and compressed gases
- on personnel
- on surfaces
In conjunction, these components will prevent and control the virulent spread of microbial, and other viable contamination, in the clean area.
Particle Measuring Systems offers a wide range of solutions that are compliant to the latest ISO/GMP requirements to ensure contamination control in critical manufacturing environments. This includes the monitoring of compressed gases.
Click here to learn more about monitoring viable and non viable particulate in compressed gasses in the Pharmaceutical and Cosmetics industries.
Products:
HPD III High Pressure Diffuser – The HPD III Aerosol Monitoring Accessory is used for monitoring non viable particulate and is compatible with non-toxic, non-flammable gases such as Clean Dry Air (CDA), Argon, and Nitrogen.
Compressed Gas Kit – The Compressed Gas Kit from Particle Measuring Systems, in conjunction with the MiniCapt Mobile microbial sampler, allows you to monitor for viable organisms in compressed gases in flexible locations around your facility.
See links to additional supporting resources below:
Webinar: Effective Compressed Gas Contamination Monitoring: Particles and Microbials
Application Note, Webinar FAQ’s: Effective Compressed Gas Contamination Monitoring: Particles and Microbials Frequently Asked Questions
Application Note: Compressed Gases: An Important Component of an Environmental Monitoring Program in a Pharmaceutical Manufacturing Environment
Application Note: Sampling Compressed Gas with the Lasair III Particle Counter
Application Note: Microbial Survival in Compressed Gases Under Fast Decompression to Normal Atmospheric Conditions
Applicable Standards: 21 CFR 211 & cGMP, ISO 14644-2, EU GMP Annex 1
Want to read more? Jump to other released posts in this series:
Part 1 of 2: Standards
Part 2 of 2: Monitoring Program (You are here!)
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