N.31 – Performances of TRIO.BAS air sampler according ISO 14698

TRIO

Glossary

Airborne, Alert Level, As-built, AT-Rest, Bacteria, Bio-contamination, Cleaning, CleanRoom, Contact Plate, Controlled Environment, Culture Medium, Disinfection, Micro-organisms, Impact-Sampler, Risk Zone, Sampling Devices, Sampling Plan, Sterilization, Unidirectional Air Flow, Validation, Viable Particles.

Introduction

The Annex A of ISO 14698-1 “Cleanrooms and Associated Controlled Environments Biocontamination control” – provides guidance on the measurement of airborne biocontamination.

This measurement involves collection of representative samples for the detection of those viable particles that need to be controlled and monitored.

Principle (A.2 Annex

A)    [endif]Detection and monitoring of microbial contamination of the air in a risk zone is carried out by collecting viable particles with appropriate sampling devices, according to a sampling plan, when the risk zone is in the as-built and at-rest states as appropriate, and routinely under normal operation in the risk zone.

Selection of a sampling devices (A.3.2 Annex A) Factors to consider for the selection of a microbial Air sampling system ISO 14698 Annex A – (A.3.2 Selection of a sampling device) TRIO.BAS characteristic and performances
Type and size of viable particles to be sampled The TRIO.BAS air samplers collect micro-organism between 1.0 and 19 microns
Expected concentration of viable particles The TRIO.BAS air samplers can be programmed from 10 to 2.000 litres of air and are therefore able to collect the expected concentration of micro-organism
Sensitivity of the viable particles to the sampling procedure The air flow rate of TRIO.BAS air samplers doesn’t Influence the viability of the collected  micro-organism
Ability to detect high or low levels of bio-contamination The possibility of SAS instruments to sample large or low volumes of air permits to operate in environments with high or low level of  bio-contamination
Appropriate culture media The TRIO.BAS  instruments are usable with any type of  culture  media in Petri or Contact Plate
Time and duration of sampling The TRIO.BAS air samplers are programmable with “remote”, “multi-aspiration”, “delay” functions and therefore is able to obtain representative samples in terms of time and duration of sampling cycles
Ambient conditions in the environment being sampled The TRIO.BAS family of air samplers is usable in all  Environmental conditions of a Clean Room. Specific instruments are also dedicated to isolatorsand explosion risk ATEX.
Disturbance of unidirectional airflow by the sampling procedure The TRIO.BAS instruments do not disturb the  unidirectional air flow of the Clean Room

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