THE EVOLUTION OF MICROBIAL ENVIRONMENTAL MONITORING IN CLEANROOM “FROM PAPER TO PAPERLESS”
The microbiological tests executed in a typical Cleanroom are four: 1) Passive Air 2) Active Air 3) Compressed air 4) Surface.
With the name of P.A.C.A.S. (Passive – Active – Compressed Air – Surface), we introduce a system which is compliant with data integrity and has the purpose to reduce partially the paper work (from paper to paper-less).
At the end of microbiological examinations all data is recorded in a document where the the picture of final results of colony growth is included as well.
The most important features are:
Compliant with DATA INTEGRITY CFR21 annex 11
Track of the complete sampling process from plate to CFU recording
No modifiable data
1 - The operator can select the sampling’s mode on the air sampler, choosing from:
PASSIVE AIR -> performed by the settle method
ACTIVE AIR -> performed by the air sampler
COMPRESSED GAS -> performed by a gas system
SURFACES -> performed by TRIO.CPS
2 - All data is recorded on the air sampler
3 - Data is transferred from the air sampler to the BAS software in compliance with the rules set in the CFR 21 part 11 directives
VERIGAS is a complementary instrument for all TRIO.BAS air samplers. The VERIGAS allows the operator to sample gas or compressed air (EASYGAS) and to check if the air sampler is still calibrated.
It consists of a digital control unit with a tube to connect 2 different bells chambers: a stainless steel bell chamber with an on/off valve to sample compressed air and gas and a regulator for
gas pressure test (EASYGAS) and a technopolymer bell chamber to control the air flow rate during the routine activity (VERITEST). VERIGAS can be used with TRIO.BAS, AIRBIO and MULTIFLEX air samplers.
EASYGAS: the bell chamber, the valve and the regulator are in AISI 316 rated stainless steel. The bell’s gasket is in silicone. All autoclavable.
VERITEST: the bell chamber is in technopolymer
Volume of aspirated air for EASYGAS: 100 litres/min and can check both 100 and 200 l/m flow rate
As requested by Good Laboratory Practice and Data Integrity 21 CFR part 11, the BAS Software
records culture plates’ photos immediately before and after the manual CFU count thanks to the
CFU Photo Camera (code 337).
The CFU Photo Camera is connected to the PC with the BAS Software installed and the two pictures
are automatically recorded and saved in the software. It is possible to export all detailed
information of a single sample in a pdf file or print a paper copy.