Elements of a comprehensive environmental monitoring program, including compressed gas contamination monitoring.
Controlling the environment in which pharmaceutical and cosmetic products are manufactured is a key element of Good Manufacturing Practices (GMP). Monitoring for contamination from compressed gases is just one element of maintaining control of a cleanroom, isolator or restricted access barrier system (RABS). The following requirements are mandated by ISO14644, 21 CFR 11 & EU GMP Annex 1 and generally accepted cGMPs worldwide. They are considered the highest level of environmental control for manufacturing in all industries and countries and are the gold standard for a comprehensive contamination control program. This is an excellent monitoring plan to model a less or non-regulated manufacturing facility, as the safeguards in this level of environmental control check and balance each other to ensure optimal facility control.
The first table below includes controls for non-viable particles in the clean environment, including compressed gases. The standards for this form of particle monitoring include:
- Total particulate content in the room/building.
- Differential pressures between clean areas
- Directional airflow
- Temperature and humidity
Since these factors affect each other, controlling them together forms the basis for overall environmental control. By keeping track of the values of each component, a cleanroom manager can anticipate and correct problems before the entire environment is affected.
This second table controls microbial organisms in the clean environment and in compressed gases. The standards for this form of particles include the number of viable organisms:
- in rooms/enclosures and compressed gases
- on personnel
- on surfaces
In conjunction with these components, the virulent spread of microbial and other viable contaminants in the cleanroom is prevented and controlled
Particle Measuring Systems offers a wide range of solutions that meet the latest ISO/GMP requirements to ensure contamination control in critical production 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
Application Note: 21 CFR 211 & cGMP, ISO 14644-2, EU GMP Annex 1
Want to read more? Jump to other posts in this series:
Part 1 of 2: Standards
Part 2 of 2: Compressed Gas Contamination Monitoring Program (You are here!)
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