Why do I need to sample compressed gases for the presence of micro-organisms?
Compressed air plays a vital role in various manufacturing processes, such as controlling valves and cylinders, cutting materials, mixing substances, and packaging goods. Within the humid environment of a compressed air system, micro-organisms like bacteria, yeasts, and molds find ideal conditions for growth. These micro-organisms can pose significant risks to manufacturers, potentially leading to product contamination, recalls, a loss of public trust, and in severe cases, facility closures and revenue losses. To ensure product quality and prevent contamination, manufacturers must establish a comprehensive compressed air monitoring program.
If a facility incorporates compressed air or gas in their manufacturing processes, it is essential to include microbial testing as part of their compressed air monitoring plan. Manufacturers typically employ Microbial Impaction Samplers to assess the cleanliness of their compressed air systems. The analysis of ensuing microbial growth aligns with ISO 8573-7 standards. This analysis provides critical data, including the total plate counts of colony forming units (CFU) and the classification of bacterial cell wall morphologies into two main categories: Gram-positive or Gram-negative.
What are the limits for the CFU count when sampling gases?
The accepted microbial contamination is related to the Good Manufacturing Practice (GMP) interpretation.
FDA Aseptic Filling Guidance - “A compressed gas should be of appropriate purity and its microbiological quality after filtration should be equal to or better than that of the air in the environment into which the gas is introduced”.
ISPE Good Practice Guide – “Typically equal to the at rest condition of the area served”.
ISO 14644 / EU GMP Grade A Class 5 – “<1 CFU/m3”.
Therefore the acceptable level of micro-organisms is related to the cleanroom class.
Analis is exclusive distributor for Orum gas samplers in Belgium and the Netherlands. Discover our solutions:
Tests microbiological quality of compressed air/gas used in cleanrooms
Test quality of Air/Nitrogen/CO2
Compressed gas test and check of the precision level
Tests microbiological quality of compressed air/gas used in cleanrooms microbiological quality of compressed air/gas used in cleanrooms
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Test microbiological quality of compressed air/gas used in cleanrooms.
The TRIO.GAS guarantees that product contact air is contamination-free within sterile or aseptic manufacturing facilities (e.g. cleanroom)
The main customers are pharmaceuticals, cleanrooms, food and dairy industries.
TRIO.GAS SYSTEM complete of s/s electrovalve, gas connection, s/s fixing system for air sampler, carrying case, and 1 certificate of calibration (TRIO.BAS MONO Bluetooth air sampler or ASPI GAS CHAMBER are not included and should be ordered separately).
FLUGAS is a microbiological sampler to test the quality of compressed air, Nitrogen, CO2 or other gas in Cleanroom.
FLUGAS System Petri contains flow meter, ASPIGAS chamber, aspirating head Petri and digital timer.
If the FLUGAS System is used in combination with ASPIGAS chamber, the test is manual and the time is calculated by a digital timer.
If the FLUGAS System is used in combination with a TRIO.BAS or an AIRBIO ONE air sampler the whole cycle of the test is programmed automatically, controlled and recorded by the software of the device. The sampling data can be transferred via cable or Bluetooth to a PC with a dedicated software according to GMP and GPL.
VERIGAS is a complementary instrument for TRIO.BAS Microbial Air Sampler
The VERIGAS system consists of ONE digital command unit and TWO different bells
(EASYGAS + VERITEST) which perform TWO different tests:
- When using EASYGAS, it sample the compressed gas in the cleanroom. The linked digital control unit functions as a flow meter to manage the gas or air flow from the compressed supply before it passes through the microbiological sampler.
- The VERITEST checks the level of precision of the flow rate in all microbiological air samplers. The result is displayed at the conclusion of the test. displayed as either WARNING or ERROR (the air sampler is not calibrated within calibration requirements) or OK (the air sampler is still calibrated) on the control unit.
The VERIGAS ascertains variations in pressure produced by the air sampler as it draws air through a bell-shaped aspirating chamber that is affixed to the sampler's head and made of technopolymer for VERITEST and stainless steel for EASYGAS. A sensor for differential pressure measures this fluctuation and compares it to the standards.
The EASY GAS checks that product contact air is contamination free within sterile or aseptic manufacturing facilities like Cleanroom
Any air sampler is easily and aseptically connected to the output of compressed gas.
Before entering the aspiration head of a TRIO.BAS air sampler, the air flow from the compressed supply is regulated by a flow valve.
All the sampling data is transferred via Bluetooth or cable (depending on the TRIO.BAS model used) to a PC by a dedicated software according to GMP and GLP.
It can be used in combination with TRIO.BAS, AIRBIO and MULTIFLEX air samplers.
SOP (Standard Operating Procedure) available from Application Notes.
