TRIO.BAS™
Isolator Rabs

One external command unit fabricated completely in stainlees steel connected to 1 or 2 or 3 satellites with Bluetooth capability and cable for charging

  • 100 or 200 litres per minute flow rate model
  • Battery charger via cable (110/240 Volt)
  • Bluetooth for data transfer

Use and application

  • Pharma, Cleanroom, Biotechnology, Fermentation, Medical Device
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  • The RABS ISOLATOR and the satellites are fabricated in AISI 316 rated stainless steel
  • This air sampler is especially dedicated to customers who make a large number of controls, in different environments, with a large staff rotation in compliance with the quality standards and QM/GMP
  • Main customers are pharmaceuticals, cleanrooms and biotech industries
  • A barcode module, thanks to the use of a scanner (barcode reader) with Bluetooth, automatically records the operator, place and plates used for the sampling. The data collected by the barcode reader are transmitted directly to the instrument. This solution is useful for those who already use culture plates with barcode or 2-D barcode (QR Quick Response Code)
  • The data is transferred via Bluetooth between the air sampler and a smartphone or tablet (Android version) and then to a PC or laptop
  • The data may be transferred via cable, too. This is helpful for all companies that, due to internal policy, are not allowed to use wireless transfer
  • It is possible to work either in manual or automatic mode
  • The battery is recharged by a power cable connected directly to the air sampler
  • The 200 lts/min air flow reduces the operator time and the time sampling
  • This air sampler allows monitoring of separated cleanrooms with a single external command unit. The risk of human contamination is reduced, because the satellite units are permanently inside each cleanroom
  • The use of sterile "Daily Shift" aspirating heads reduces the risk of contamination
  • The possibility to use 1/2/3 different aspirating heads allows to have 1/2/3 different culture media at the same time or the ability to sample BEFORE (at rest), DURING (in operation) and at the END of each processing cycle
  • AISI 316 rated stainless steel (command unit + satellite units)
  • Compliant with ISO 14698-1, EN 17141, GMP and GAMP
  • Stainless steel aspirating head with quick bayonet closure, identification number and stainless steel cover to prevent contamination
  • Volume of aspirated air: 100 or 200 l/m
  • Selected volumes from 30 to 2.000 litres and 17 preset programs
  • The aspirating chamber is suitable for 55 mm Contact plates or 90 mm Petri dishes
  • Auto calibration: power/flow electronic real time control
  • Power supply system: the instrument can be charged continuosly by AC powered source 110/240 Volt 50/60 Hz or by rechargeable batteries (inserted inside the air sampler)
  • Cycles battery autonomy: 70.000 litres
  • Language: English, French, German, Spanish, Italian
  • Operative aspirating cycles: manual and automatic
  • Memorized data: up to 1.000 samples
  • Configuration of 100 users and 100 places
  • Delay time, fraction time and fraction number
  • Bluetooth connection or use of cable for data transfer
  • Automatic next calibration reminder
  • Data integrity CFR 21 and GAMP5
  • CE mark
  • Continuous/trending analysis according to the USP
  • Dimension: 25x13x18h cm
  • Weight: 3.150 gr
  • Built in ISO 9001 premises
Code TRIO.BAS RABS ISOLATOR WITH 1 SATELLITE PACK (*)
268K TRIO.BAS™ RABS ISOLATOR 100 Contact with 1 Satellite PACK
269K TRIO.BAS™ RABS ISOLATOR 100 Petri with 1 Satellite PACK
270K TRIO.BAS™ RABS ISOLATOR 200 Contact with 1 Satellite PACK
271K TRIO.BAS™ RABS ISOLATOR 200 Petri with 1 Satellite PACK

(*) each PACK consists of: 1 TRIO.BAS™ RABS ISOLATOR with battery charger, 1 calibration certificate, 1 s/s satellite, 1 s/s aspirating head with s/s cover head, 1 cable connection (5 mt), 1 cable for data transfer, 1 robustus medium carrying case.

Code SATELLITE UNIT PACK(*)
260K SATELLITE UNIT Contact PACK
261K SATELLITE UNIT Petri PACK
262K SATELLITE with HEPA FILTER Contact PACK
263K SATELLITE with HEPA FILTER Petri PACK

(*) each PACK consists of: 1 s/s satellite, 1 s/s aspirating head with s/s cover head, 1 cable connection (5 mt).
(**) second or third satellite to be added to basic sampler.

Code SATELLITE ACCESSORIES
180 S/S IN REST holder (code 180) for Petri dish, ASPIRATING head
265 CABLE CONNECTION between the satellite and the command unit - 1 set of 5 meters
272 CABLE CONNECTION between the satellite and the command unit - 1 set of 20 meters

Satellites can be used with:

  • 90 mm Petri dishes with s/s aspirating head
  • 55 mm Contact plates with s/s aspirating head
  • Sterile technopolymer “Daily Shift” aspirating heads
  • BACTair™ disposable culture media sterile plate complete with sterile aspirating head

TRIO.BAS™

Standard Stationary Satellite

The compact satellite occupies little space inside the isolator. This format is typically used in cleanrooms, RABS and isolator. These satellites can be used in connection with TRIO.BAS RABS ISOLATOR or MULTIFLEX (100 or 200 l/m). The exhausted air flow is lateral without turbolence. All types of aspirating heads and connection cables can be ordered separately. Size: diameter 12 cm, height 12 cm, weight 1.170 gr.

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TRIO.BAS™

Stationary Satellite with HEPA filter

The HEPA filter eliminates the risk of particulates in the expelled air. The compact satellite occupies little space inside the isolator. These satellities can be used in connection with TRIO.BAS RABS ISOLATOR or MULTIFLEX 100 lt/m This format is typically used inside RABS and isolator. The exhausted air flow is without turbulence. The life of HEPA filters depend on how the sampler works. Replacement is recommended every 6/12 months. If the HEPA filter becomes clogged by this period, the sampler alarm system warns the operator that the airflow is irregular and therefore it is necessary to replace the filter. All types of aspirating head and connection cable can be ordered separately. Size: diameter 12 cm, height 17 cm, weight 1260 gr.

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TRIO.BAS™

Stationary Satellite TRI CLAMPS

This format is typically used in cleanrooms, RABS and isolator. These satellites can be used in connection with TRIO.BAS RABS ISOLATOR or MULTIFLEX for 100 or 200 lt/m. The compact satellite occupies little space inside the isolator. The electric connection cable which connects the command unit to the satellite lays protected inside the s/s tube. The satellites are supplied with a connection clamp end ¾”, positioned on the bottom side. The exhausted air flow is without turbulence and it remains inside the cabinet. All types of aspirating head and connection can be ordered separately. Size: diameter 12 cm, height 12 cm, weight 1.170 gr.

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TRIO.BAS™

Stationary Satellite Ready Plate

This satellite is specifically designed to work with the BACTair™ disposable culture media sterile plates complete with sterile aspirating heads. The compact satellite occupies little space inside the isolator.The combination with sterile culture media plates and the sterile aspirating heads facilitates the handling inside the cabinet. This special plate can be used directly during sampling without any further preparation.This is typically used in cleanrooms, RABS and isolator.These satellites can be used with TRIO.BAS RABS ISOLATOR or MULTIFLEX 100 l/m. The exhaust air flow is without turbulence.The BACTair™ plate and the connection cable need to be ordered separately. Size: diameter 12 cm, height 15 cm, weight 1.270 gr.

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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.
507 PQ documents for DUO, TRIO, MULTISTATION/ISOLATOR, AIRBIO ONE, AIRBIO DUO

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.
507 PQ documents for DUO, TRIO, MULTISTATION/ISOLATOR, AIRBIO ONE, AIRBIO DUO

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.
507 PQ documents for DUO, TRIO, MULTISTATION/ISOLATOR, AIRBIO ONE, AIRBIO DUO

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.
507 PQ documents for DUO, TRIO, MULTISTATION/ISOLATOR, AIRBIO ONE, AIRBIO DUO

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.
507 PQ documents for DUO, TRIO, MULTISTATION/ISOLATOR, AIRBIO ONE, AIRBIO DUO

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
394 ROBUSTUS MEDIUM TR carrying case for TRIO.BAS MULTIFLEX 1+2/RABS ISOLATOR with 1-3 Satellites - size 560x430x220H mm - weight 4,6 kg.
507 PQ documents for DUO, TRIO, MULTISTATION/ISOLATOR, AIRBIO ONE, AIRBIO DUO

TRIO.BAS™

BLUETOOTH PRINTER

Ultra-light and compact portable Bluetooth printer with high printing autonomy. It has an end paper sensor and prints most popular barcodes. A practical belt hook, a battery charger, one paper roll and USB cable are included.

ID PACK CODE

Code
520 BLUETOOTH PRINTER - Size 11x9x5h cm - weight 450 gr.
507 PQ documents for DUO, TRIO, MULTISTATION/ISOLATOR, AIRBIO ONE, AIRBIO DUO

TRIO.BAS™

ROOL PAPER for Bluetooth printer

The ROLL PAPER is no erasable thermal paper. The paper is printed thermally but it keeps the ink during the time.

ID PACK CODE

Code
421 ROLL PAPER standard - Size 57 mm - 10 per box.
507 PQ documents for DUO, TRIO, MULTISTATION/ISOLATOR, AIRBIO ONE, AIRBIO DUO

TRIO.BAS™

THERMAL ROLL PAPER for Bluetooth printer

For BLUETOOTH PRINTER - size 57 mm - 10 x box FEATURES - no erasable thermal paper for TRIO. PRINTER - The paper is printed thermally but it keeps the ink during the time.

ID PACK CODE

Code
423 THERMAL ROLL PAPER - size 57 mm - 10 x box.
507 PQ documents for DUO, TRIO, MULTISTATION/ISOLATOR, AIRBIO ONE, AIRBIO DUO

TRIO.BAS™ BARCODE READER BLUETOOTH 1D 2D USE
TRIO.BAS™

BARCODE READER BLUETOOTH 1D 2D USE

This miniature barcode reader, frequently used in microbiological air monitoring procedures, can help save time, better control the activity of the operators and achieve complete traceability of the sampler tests . Can be use for identification ID of the plate with 1D or 2D code, locations and operators.

ID PACK CODE

Code
294 Barcode reader Bluetooth - size 6ox35x15h mm - weight 45 gr.
507 PQ documents for DUO, TRIO, MULTISTATION/ISOLATOR, AIRBIO ONE, AIRBIO DUO

TRIO.BAS™ LOCATION PRESET BARCODE TAG
TRIO.BAS™

LOCATION PRESET BARCODE TAG

It is used to personalize the location where the sampling is made.

ID PACK CODE

Code
291 Location Barcode TAG - Size 85x55 mm - 10 per box.
507 PQ documents for DUO, TRIO, MULTISTATION/ISOLATOR, AIRBIO ONE, AIRBIO DUO

TRIO.BAS™ PORTABLE COMMAND UNIT (CPU)
TRIO.BAS™

PORTABLE COMMAND UNIT (CPU)

This device comes with already installed APP Android ASAPP.

The CPU Portable Command Unit is an ideal instrument to simplify and to facilitate the activity of operator.

The Bluetooth connection with all TRIO.BAS™ instruments allows to download the sampling data.

The PCU can also be used to control the switch on, switch off and pause of the air sampler remotely.

The data downloaded from the instruments through the CPU, can be transferred to a PC where Air Sampler ASPC software (code 295) or BAS software (code 296) is installed (i.e. by USB connection).

ID PACK CODE

Code
301 PORTABLE COMMAND UNIT CPU - 10”
507 PQ documents for DUO, TRIO, MULTISTATION/ISOLATOR, AIRBIO ONE, AIRBIO DUO

TRIO.BAS™ AS Software
TRIO.BAS™

AS Software

This software manages the sampling data transfer from the air sampler to the PC.

ID PACK CODE

Code
295 "AS Software" - transfer data from instrument or smartphone/tablet to PC by Bluetooth.
507 PQ documents for DUO, TRIO, MULTISTATION/ISOLATOR, AIRBIO ONE, AIRBIO DUO

TRIO.BAS™ APP Android
TRIO.BAS™

APP Android "ASAPP"

APP Android "ASAPP" - transfer data from instrument to smartphone/tablet to PC by Bluetooth.

ID PACK CODE

Code
300 APP Android "ASAPP" - transfer data from instrument to smartphone/tablet to PC by Bluetooth.
507 PQ documents for DUO, TRIO, MULTISTATION/ISOLATOR, AIRBIO ONE, AIRBIO DUO

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.
507 PQ documents for DUO, TRIO, MULTISTATION/ISOLATOR, AIRBIO ONE, AIRBIO DUO

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.
507 PQ documents for DUO, TRIO, MULTISTATION/ISOLATOR, AIRBIO ONE, AIRBIO DUO

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.
507 PQ documents for DUO, TRIO, MULTISTATION/ISOLATOR, AIRBIO ONE, AIRBIO DUO

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
502 IQ, OQ documents for DUO, TRIO, MULTISTATION/ISOLATOR, AIRBIO ONE, AIRBIO DUO
507 PQ documents for DUO, TRIO, MULTISTATION/ISOLATOR, AIRBIO ONE, AIRBIO DUO