Data Integrity - P.A.C.A.S. System

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
  • Time saving

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

The software

BAS Software

The Software is a fundamental part for collecting and analysing data from the air samplers. The new generation of TRIO.BAS software gives the possibility to apply the request of the new ANNEX 1

OPEN SCHEME

Innovations

Passive – Settle air sampling
Active air sampling
Compressed air-gas sampling
Surface & Garments

The complements

Trio Settle

360° movable tilting table stainless steel support for passive air sampling. The support can be placed either on the table or on the floor with a dedicated tripod.

Available Industries

Innovations

TRIO.SETTLE is a device developed to standardize, test and enumerate the presence of microorganisms according to settle plate method.
TRIO.SETTLE can be fixed on a tripod or on other floor support devices
TRIO.SETTLE is fabricated in AISI 316 stainless steel and it is fully autoclavable.

VERIGAS

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.

Available Industries

Innovations

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

TRIO.CPS

TRIO.CPS is used to evaluate the correct cleaning of all surfaces in contact with food and dairy, pharma and hospital products to validate the HACCP and training of the staff.

Available Industries

Innovations

Timer: 10 seconds
Operating temperature: 0-40°C
Size: diameter 95x45H mm

CFU Photo Camera

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.

Available Industries

Innovations

Light System: LED technology
Camera resolution: full HD 1080p
Construction: technopolymer antibacterial treatment

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