TRIO.BAS™
MULTIFLEX 1

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.

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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).

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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).

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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

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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

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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

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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.

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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).

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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.

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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.

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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.

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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.

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LOCATION PRESET BARCODE TAG

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

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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.

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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.

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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).

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AS SOFTWARE

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

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APP ANDROID "ASAPP"

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

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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.

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APP ANDROID "BASAPP"

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

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