Compressed Gas Contamination Monitoring

Monitoring Particulates and Microbials  in Compressed Gases

Compressed gases can be viewed as critical utilities in many industries when either in direct product contact or directly entered into the clean room environment.

Particle Measuring Systems offers a wide range of solutions, compliant to the latest ISO/GMP requirements, to ensure the contamination control in critical environments including the monitoring of compressed gases. This includes viable and non-viable monitoring for the Pharmaceutical industry and sensitivity to 10 nm in inert gases and 100 nm in corrosive gases for Electronics customers. 

Control of the environment in which pharmaceutical products are manufactured is a key element of Good Manufacturing Practices (GMP). Monitoring of particles & microorganisms in manufacturing cleanrooms, Restricted-Access Barrier Systems (RABS), and isolators consists of clearly defined components listed in the table below.

Absence of viable and non-viable contamination is considered a critical quality attribute due to its potential to dramatically impact, directly or indirectly, the safety and/or the efficacy of the drug product. Moreover, compressed gases can be viewed as critical utilities in pharmaceutical Industry when either in direct product contact or directly entered into the clean room environment.

Particle Measuring Systems offer a wide range of solutions, compliant to the latest ISO/GMP requirements, to ensure the contamination control in critical environments including the monitoring of compressed gases.

CG-Table-1-(2).PNGCG-Table-2-(1).PNG

Knowledge / Papers

Compressed Gases: An Important Component of an Environmental Monitoring Program in a Pharmaceutical Manufacturing Environment

Compressed Gases: A Brief Regulatory Overview

The testing and monitoring of compressed air and other process gases such as gaseous and liquid nitrogen, oxygen, argon, and carbon dioxide that come into direct contact with pharmaceutical drugs during the manufacturing process is vital to assuring the quality and safety of these products. Compressed air is a Critical Process Parameter (CPP) whose variability has an impact on the Critical Quality Attribute and therefore should be monitored or controlled to ensure the process produces the desired quality.

read all

Microbial Survival in Compressed Gases Under Fast Decompression to Normal Atmospheric Conditions

Compressed gases are broadly used in medicinal production facilities. A variety of different gases can be introduced into the process at various stages of a product’s manufacture for different reasons. Compressed gases such as air, nitrogen, and carbon dioxide are regularly used in cleanrooms and are frequently employed in purging or overlaying. The cleanliness of compressed gases used during the pharmaceutical manufacturing process is a very important quality factor because in many instances, the gas comes into contact with the medicinal product.

read all

Sampling High-Pressure Gases

This paper describes fundamental relationships between air or gas volume, pressure, and flow, and how these relationships affect particle counting.

read all

Unparalleled flexibility for Cleanroom and Compressed Gas classification and monitoring activities.

  • Lasair III particle Counter and Minicapt Mobile Sampler support the compliance with the latest
  • ISO 8573 and ISO 14644-1:2015

 

Lasair® III Airborne Particle Counter

Lasair® III Airborne Particle Counter

Sets the standard for portable aerosol particle counters and meets the requirements of ISO 14644-1:2015 and  ISO 21501-4

MiniCapt® Mobile Microbial Air Sampler

MiniCapt® Mobile Microbial Air Sampler

The innovative solution to microbial air sampling. ISO 14698:2003 compliant

Lasair® III 110 Airborne Particle Counter

Lasair® III 110 Airborne Particle Counter

A true 0.10 μm particle counter, providing real-time measurement of yield-impacting particles with three configurations.

HPGP-101-C High Pressure Gas Probe

HPGP-101-C High Pressure Gas Probe

Provides reliable in-line contamination monitoring for process gases at line pressure

Get a Quote

Lasair® III Airborne Particle Counter

Lasair® III Airborne Particle Counter

Sets the standard for portable aerosol particle counters and meets the requirements of ISO 14644-1:2015 and  ISO 21501-4

MiniCapt® Mobile Microbial Air Sampler

MiniCapt® Mobile Microbial Air Sampler

The innovative solution to microbial air sampling. ISO 14698:2003 compliant

Lasair® III 110 Airborne Particle Counter

Lasair® III 110 Airborne Particle Counter

A true 0.10 μm particle counter, providing real-time measurement of yield-impacting particles with three configurations.

HPGP-101-C High Pressure Gas Probe

HPGP-101-C High Pressure Gas Probe

Provides reliable in-line contamination monitoring for process gases at line pressure

Get a Quote

Ask a Question

Compressed Gas Contamination Monitoring

 

Do you have a question? Submit your question and one of our experts will respond shortly.