TRIO.BAS™
Trio.gas system

Test microbiological quality of compressed air/gas used in cleanrooms. To be used with ASPIGAS chamber, TRIO.BAS or AIRBIO instruments

  • It works only at 100 l/m
  • It is ready to be used: no initial regulation is requested as the valve is already calibrated at 100 l/m
  • It works with ASPI GAS CHAMBER or an air sampler 100 l/m
  • Suitable for compressed air and Nitrogen
  • Calibration certificate every year
  • Inlet gas pressure 1 - 6 BAR

Use and application

  • Pharma, Cleanroom, Biotechnology, Fermentation, Medical Device
  • Food, Dairy, Beverage, Agro, Catering, Cosmetics
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  • The TRIO.GAS guarantees that product contact air is contamination free within sterile or aseptic manufacturing facilities (e.g. cleanroom)
  • Main customers are pharmaceuticals, cleanrooms, food and dairy industries
  • The system is according to ISO Standard 8573-7 and ISO 14698-1
  • Before passing through a TRIO.BAS air sampler, the air flow from the compressed supply is regulated by an autoclavable valve
  • All the sampling data are transferred via Bluetooth (if using a TRIO.BAS air sampler) to a tablet/smartphone or via Bluetooth to PC by downloaded dedicated software according to GMP and GLP
  • When TRIO.GAS is used in combination with a TRIO.BAS air sampler, the time is regulated by the software of the air sampler
  • When TRIO.GAS is used in combination with ASPI Gas Chamber, the test is manual and the time is regulated by a timer counter
  • Completely made in AISI 316 rated stainless steel
  • Totally sterilizable via autoclave with no disassembly required
  • Volume of aspirated air: 100 litres/min
  • The aspirating chamber is suitable for 90 mm Petri dishes or 55 mm Contact plates
  • Compliant with ISO 14698-1, EN 17141, ISO 8537-7 and FDA
  • Dimension: 40x18x25h cm
  • Weight: 5.290 gr
  • Built in ISO 9001 premises
Code TRIO.GAS SYSTEM (*)
652K(*) TRIO.GAS with ASPIGAS chamber Contat plate
653K(*) TRIO.GAS with ASPIGAS chamber Petri 90
654K(**) TRIO.GAS with TRIO.BAS MINI Contact plate
655K(**) TRIO.GAS with TRIO.BAS MINI Petri 90
650K(***) TRIO.GAS with TRIO.BAS MONO 100 induction Contact
651K(***) TRIO.GAS with TRIO.BAS MONO 100 induction Petri
657K(***) TRIO.GAS with TRIO.BAS MONO 100 cable Contact
658K(***) TRIO.GAS with TRIO.BAS MONO 100 induction Petri
600 TRIO.GAS SYSTEM - structure and calibrated valve in stainless steel AISI 316 - Robustus large carrying case
470 ASPIGAS CHAMBER with ASPIRATING HEAD and cover for Contact plate – stainless steel AISI 316 - Light carryin case
471 ASPIGAS CHAMBER with ASPIRATING HEAD and cover for Petri 90 – stainless steel AISI 316 - Light carrying case

(*) each PACK consists of: 1 TRIO.GAS , 1 ASPIGAS chamber, 1 s/s aspirating head with s/s cover head, 1 timer, 1 robustus large carrying case, 1 light carrying case, calibration certificate
(**) each PACK consists of: 1 TRIO.GAS , 1 TRIO.BAS MINI , 1 s/s aspirating head with s/s cover head, 1 robustus large carrying case, 1 light carrying case, 2 calibration certificates
(***) each PACK consists of: 1 TRIO.GAS , 1 TRIO.BAS MONO, 1 s/s aspirating head with s/s cover head, 1 robustus large carrying case, 1 robustus standard carrying case, 2 calibration certificates

Note
Data must be manually recorded and sample must be timed when using ASPIGAS chamber without a TRIO.BAS™ or AIRBIO instrument

TRIO.BAS™

MINI MULTI HOLDER cart on wheels

This cart is suitable ideally for cleanrooms.

It is robust and is easily used with an air sampler fixed on it. It is equipped with 2 shelves.

It is suitable for sampling at a medium height. Optional: stand up holder for TRIO.BAS MINI (code 370), stand up holder for TRIO.BAS MONO, DUO, TRIO (code 376) or stand up holder for AIRBIO (code 377).

ID PACK CODE

Code
371 MINI MULTI HOLDER cart on wheels - stainless steel AISI 314 and 316 - size 500x400x850H mm - weight 6 kg.
509 IQ, OQ documents for TRIO.GAS

TRIO.BAS™

IN-REST holder

Operators, and their activities, represent the greatest risk of contamination inside cleanrooms. Operators must work under stringent conditions; required to wear special overalls, gloves, facemasks, and eye masks. For these reasons, it is advisable to create the best possible working conditions. Air sampling with microbiological samplers is a complex and delicate operation, whether using an instrument with a single aspirating head, or an instrument with more than one aspirating head. To facilitate operations and avoid errors and risks of contamination during the sampling phase, the TRIO.BAS IN-REST is particularly useful as a temporary support for culture media plates and/or lids, and instrument sampling heads.

  • Wedge shape inclined at 150°
  • Autoclavable
  • Two-sided Support
  • Usable for Petri dishes, Contact plates , s/s Cover, s/s Aspirating heads, Daily shift head
  • A single hole on one side, and two holes on the other side, facilitate identification of plates and heads

ID PACK CODE

Code
180 IN-REST holder - Stainless steel AISI 316 - size 90x120x105H mm - weight 127 gr.
509 IQ, OQ documents for TRIO.GAS

TRIO.BAS™

GLP EASY RACK

Cleanroom stainless steel rack with handle for stacking, storing and transporting culture plates (Petri or Contact plate). They are used to maintain the distance inside the incubator according the GLP (Good Laboratory Practice).

  • Sterility Traceability.
  • Triple-wrapped and individually sealed to ensure sterility.
  • Beta or Gamma sterilization certificate available.
  • Color is easy to identify in the cleanroom.
  • Write-on oversized area to identify sample contents suitable for use with permanent markers.
  • Self-adhesive flap closure prevents contamination after samples are placed inside of the bag.
  • Included an easy-open thear line which guarantees the sterility of the single bag.
  • The elongated, flat bag design facilitates stacking of multiple bags, easy reading of bag contents, and allows plate lids to stay secured inside the bag during handling.

ID PACK CODE

Code
176 GLP EASY RACK Petri - stainless steel AISI 316 - capacity up 11 Petri dishes 90 mm - size 110x215H mm - weight 285 gr.
509 IQ, OQ documents for TRIO.GAS

TRIO.BAS™

GLP EASY RACK

Cleanroom stainless steel rack with handle for stacking, storing and transporting culture plates (Petri or Contact plate). They are used to maintain the distance inside the incubator according the GLP (Good Laboratory Practice).

  • Sterility Traceability.
  • Triple-wrapped and individually sealed to ensure sterility.
  • Beta or Gamma sterilization certificate available.
  • Color is easy to identify in the cleanroom.
  • Write-on oversized area to identify sample contents suitable for use with permanent markers.
  • Self-adhesive flap closure prevents contamination after samples are placed inside of the bag.
  • Included an easy-open thear line which guarantees the sterility of the single bag.
  • The elongated, flat bag design facilitates stacking of multiple bags, easy reading of bag contents, and allows plate lids to stay secured inside the bag during handling.

ID PACK CODE

Code
175 GLP EASY RACK Contact - stainless steel AISI 316 - capacity up 15 Contact plates 55 mm - size 110x215H mm - weight 285 gr.
509 IQ, OQ documents for TRIO.GAS

TRIO.BAS™

CLEANROOM BAG

Sterile bags ideal for safely containing and transporting Petri dishes, Contact plates, Swabs, or other objects, outside of the cleanroom:

  • Sterility Traceability.
  • Triple-wrapped and individually sealed to ensure sterility.
  • Beta or Gamma sterilization certificate available.
  • Color is easy to identify in the cleanroom.
  • Write-on oversized area to identify sample contents suitable for use with permanent markers.
  • Self-adhesive flap closure prevents contamination after samples are placed inside of the bag.
  • Included an easy-open thear line which guarantees the sterility of the single bag.
  • The elongated, flat bag design facilitates stacking of multiple bags, easy reading of bag contents, and allows plate lids to stay secured inside the bag during handling.

ID PACK CODE

Code
381 CLEANROOM BAG - plain sampling bag - polyethylene film - sterilized by irradiation Gamma or Beta ray - sizes: 40x13 cm. - 15 x bag - 150 x box.
509 IQ, OQ documents for TRIO.GAS

TRIO.BAS™

ROBUSTUS CARRYING CASE

These Carrying cases have very performing characteristics. This allows the instruments to be safely contained both for transport by customers when they have to carry out tests in different environments. They are also indispensable when they must be sent to accredited assistance centers to carry out repairs or calibration - Easy to open double throw latches - foam inlays to protect the instrument.

Made in polypropylene copolymer - Thick body material - range temperature -30° /+90° C - are watertight to offer protection from water ( IP67), dust and impact. No problem for airplane transport (ATA300).

ID PACK CODE

Code
398 ROBUSTUS LARGE G carrying case for TRIO.GAS - size 560x430x310H mm - weight 5,6 kg.
509 IQ, OQ documents for TRIO.GAS

TRIO.BAS™ BAS Software
TRIO.BAS™

BAS Software

This software is compliant with CFR 21 Part 11 Data Integrity. It manages the sampling data transfer from the air sampler to the PC. It also facilitates the configuration of users and places on the air sampler.

ID PACK CODE

Code
296 BAS Software license - transfer data from instrument or smartphone/tablet to PC by Bluetooth.
509 IQ, OQ documents for TRIO.GAS

TRIO.BAS™ APP Android
TRIO.BAS™

APP Android "BASAPP"

APP Android "BASAPP" - transfer data from instrument to smartphone/tablet by Bluetooth

ID PACK CODE

Code
302 APP Android "BASAPP" - transfer data from instrument to smartphone/tablet by Bluetooth.
509 IQ, OQ documents for TRIO.GAS

TRIO.BAS™

Sterile Daily Shift Aspirating Head for Contact plate

The sterile Daily Shift aspirating heads (DSH - sterile Daily Shift Head) avoid the sterilization process necessary for stainless steel aspirating heads.

The sterilization is proven by an official certificate. This document is requested by regulatory authorities.

The triple irradiated sterile packaging allows the users to always have aspirating heads ready for use.

ID PACK CODE

Code
340 Sterile Daily Shift Aspirating Head for Contact plate 55 mm - size 100 diameter X 14 H mm - weight 48 gr - in triple sterile bag (20 x box) - size 375X265X220H mm - weight 1,3 kg.
509 IQ, OQ documents for TRIO.GAS

TRIO.BAS™

Sterile Daily Shift Aspirating Head for Petri

The sterile Daily Shift aspirating heads (DSH - sterile Daily Shift Head) avoid the sterilization process necessary for stainless steel aspirating heads.

The sterilization is proven by an official certificate. This document is requested by regulatory authorities.

The triple irradiated sterile packaging allows the users to always have aspirating heads ready for use.

ID PACK CODE

Code
341 Sterile Daily Shift Aspirating Head for Petri 90 mm plate - size 102 diameter X 35 H mm - weight 52 gr - in triple sterile bag (20 x box) - size 375X265X220H mm - weight 1,4 kg.
509 IQ, OQ documents for TRIO.GAS

TRIO.BAS™ IQ, OQ, PQ documents
TRIO.BAS™

IQ, OQ, PQ documents

IQ installation qualification; OQ operational qualification; PQ performance qualification

In the pharmaceutical industry, accurate measurements are vital. Even slight errors can result in dangerous and potentially deadly consequences. This is why reliable equipment validation is so critical in the pharmaceutical industry. IQ OQ PQ represents a way to help ensure reliable performance for equipment for pharmaceutical industry purposes.

IQ, OQ and PQ stand for installation qualification, operational qualification and performance qualification, respectively. They represent quality assurance protocols for each phase of the manufacturing process for pharmaceutical equipment. Since the pharmaceutical industry is heavily regulated by the FDA, it is essential to follow IQ, OQ and PQ protocols.

These Documents have the target to verify that the instrument is working according to the supplier specification, during the installation and during the working activities.

METHOD

Read the pages of the document

ACCEPTANCE CRITERIA

Each pages of this document is based on a specific criterion that should be followed

HOW TO USE THE DOCUMENT

These Documents have the target to verify that the instrument is working according to the supplier specification, during the installation and during the working activities.

  • Do the actions described in the pages of this Document
  • Answer YES or NO to the questions present in each page
  • Insert comments and corrective actions where they are applicable
  • Date and sign each page when it has been completed
  • Record the results each time a page of the Document has been completed
  • Sign, date and register the document once it is fully completed

ID PACK CODE

Code
508 PQ documents for TRIO.GAS
509 IQ, OQ documents for TRIO.GAS