- 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
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
- 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
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 |
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.
FEATURES
- Built in AISI 316 stainless steel
- Wedge shape inclined at 150°
- Two-sided Support
- Usable for Petri dishes, Contact plates and aspirating heads
- 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 |
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).
DETAILS
- They can be refrigerated, incubated and autoclaved
- Each rack can hold up to 11 Petri dishes, or 15 Contact plates
- A wide front opening permits easy access but prevents dishes from sliding out
- The same rack can be adjusted for Petri or Contact plate
- Avoids all risk of accident during loading and transport to the incubator for staff bio-hazard safety
- The weight of only 280 gr. make it light and easy to carry
- The small size allows to maximize the space inside the incubator
- Racks are fully autoclavable
*ISO Standard and GPL request that inside the incubator the culture plates are stacked not more than six and at a distance of 2 cm.
ID PACK CODE
Code | |
---|---|
175 | GLP EASY RACK AISI 316 Petri - capacity up 11 Petri dish 90 mm. size: diam. 110x215h mm. Contact - capacity up 15 Contact plate 55mm. size: diam. 110x215h mm. |
509 | IQ, OQ documents for TRIO.GAS |
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 |
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 |
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 |
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 |
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 |
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 |
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 |