- The MULTIFLEX 1+2 air sampler and 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 collected are transferred via Bluetooth from the air sampler to a PC or laptop. PC or laptop request a dedicated software installed
- The data is transferred via Bluetooth between the air sampler and a smartphone or tablet (Android version) and then to a PC or laptop
- It is possible to work either in manual or automatic mode
- 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
- 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 to monitor 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 2/3 different aspirating heads allows to have 2/3 different culture media at the same time or to make sampling BEFORE (at rest), DURING (in operation) and at the END of each processing cycle
TRIO.BAS™
Multiflex 1+2
One external command unit completely fabricated in stainless steel with cable for charging, connected to one fixed and two independent satellites
- 100 or 200 litres per minute flow rate model
- Battery charger via cable (110/240 Volt)
- Bluetooth for data transfer
Use and application
- AISI 316 rated stainless steel (command unit + satellite units)
- Complaint according EN/ISO 14698-1, GMP and GLP
- 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 6.000 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 sampler
- Configuration of 100 users and 100 places
- Delay time, fraction time and fraction number
- Bluetooth connection or 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: 4.100 gr
- Built in ISO 9001 premises
Code | TRIO.BAS MULTIFLEX 1+2 PACK (*) |
---|---|
474K | TRIO.BAS™ MULTIFLEX 1+2 100 Contact with cable (100 litres/min flow rate) |
475K | TRIO.BAS™ MULTIFLEX 1+2 100 Petri with cable (100 litres/min flow rate) |
476K | TRIO.BAS™ MULTIFLEX 1+2 200 Contact with cable (200 litres/min flow rate) |
477K | TRIO.BAS™ MULTIFLEX 1+2 200 Petri with cable (200 litres/min flow rate) |
(*) each PACK consists of: 1 TRIO.BAS MULTIFLEX 1, 1 calibration certificate, 2 s/s satellite, 2 s/s aspirating head with s/s cover head, 2 cable connection (5 mt), 1 robustus carrying case.
Code | SATELLITE UNIT PACK(*) |
---|---|
260K | SATELLITE UNIT Contact PACK |
261K | SATELLITE UNIT 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
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.
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.
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 |
MAXI MULTI HOLDER cart on wheels
This cart is suitable mostly for cleanrooms. Adjustable height from 100 cm to 210 cm A fixed vertical hook and a vertical extensible support with ball joint are included with the cart 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 from the floor. 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 | |
---|---|
372 | MAXI MULTI HOLDER cart on wheels - stainless steel AISI 314 and 316 - size 500x400x850H mm - weight 7 kg. |
507 | PQ documents for DUO, TRIO, MULTISTATION/ISOLATOR, AIRBIO ONE, AIRBIO DUO |
MULTIFLEX HOLDER
For fixing MULTIFLEX Instruments to the s/s Tripod (code 523) or s/s Maxi Multi cart (code 372).
Ideal for placement of MULTIFLEX at various heights and cleanroom points that are not easily accessible.
Simple, stable design: The MULTIFLEX instrument easily attaches to the Holder without fixing screws.
ID PACK CODE
Code | |
---|---|
379 | MULTIFLEX HOLDER - stainless steel AISI 316 - size 250x140 mm. |
507 | PQ documents for DUO, TRIO, MULTISTATION/ISOLATOR, AIRBIO ONE, AIRBIO DUO |
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. |
507 | PQ documents for DUO, TRIO, MULTISTATION/ISOLATOR, AIRBIO ONE, AIRBIO DUO |
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. |
507 | PQ documents for DUO, TRIO, MULTISTATION/ISOLATOR, AIRBIO ONE, AIRBIO DUO |
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 |
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 | |
---|---|
392 | ROBUSTUS LARGE MM carrying case for TRIO.BAS MULTIFLEX 1+2/TRIO.BAS MULTISTATION with 1-3 Satellites - Size 560x430x220H mm - weight 5,6 kg. |
507 | PQ documents for DUO, TRIO, MULTISTATION/ISOLATOR, AIRBIO ONE, AIRBIO DUO |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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. |
507 | PQ documents for DUO, TRIO, MULTISTATION/ISOLATOR, AIRBIO ONE, AIRBIO DUO |
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 |
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 |