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Walk-in Pass Through Box

Active Bio-decon Walk-in Pass-Through Box are pass boxes that enable the aseptic transfer of materials within cleanrooms.

Materials are sterilized inside the pass-through chambers using an integrated bio-decontamination system.

 

 

Used in contexts of:

Designed and Manufactured by Tema Sinergie

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Class A

EU GMP

ANNEX 1

EU GMP

ISO 5

ISO 14644-1

GAMP 5

FDA 21 CFR PART

Custom-designed to suit individual applications

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GUARANTEED STERILITY

The AB-PTC ensures the sterility of materials through:

  • HEPA/ULPA filtration,

  • rapid bio-decontamination with vaporized hydrogen peroxide

  • a positive-pressure cascade ventilation system that maintains aseptic conditions until transfer to the cleanroom.

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AUTOMATIC LEAK TEST

The AB-PTC is equipped with an automatic leak-test system that can be performed routinely; it runs an independent cycle on each chamber in accordance with the pressure-varying method described in ISO 10648-2:1994(E), section 5.2.

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EASY MAINTENANCE

The external control module, made of AISI 304 stainless steel, simplifies maintenance operations, while the VPN connection provides secure remote access for support, updates, and system monitoring from anywhere.

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MAXIMUM SAFETY

The AB-PTC enables the safe decontamination of materials and instruments from BSL laboratories, ensuring biological containment and operator protection thanks to its integrated VPHP, pressure control, and bio-seal system.

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STANDARD DESIGN

AB-PTC is available in several standard sizes, including walk-in versions that allow direct operator access.

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ENERGY SAVING

Thanks to the new sustainable low-voltage fans, the insulator ensures extremely low energy consumption throughout its entire service life.

Additional Modules

Recommended Accessories

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DATA MANAGEMENT

Supervision, Control, and Data Acquisition System.

From the Industry

Testimonials

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“

DR.-FJALAR-KRISTJANSSON-1-e1536920476244Tema Sinergie has developed a custom-designed Walk-in Active Bio-decon Pass Through Chamber for our facility in Reykjavik and delivered two of those to us.
It is a pleasure to see how precisely and efficiently the Pass Through Chambers work, and they are just a pure joy to look at!

We have appreciated how Tema Sinergie professionally dealt with each step of the project through friendly correspondence and cooperation from the initial phases of the project through on-site installation and validation of the equipment. The chambers are currently in complete operational readiness, and successfully support our aseptic processing.

— — Dr. Fjalar Kristjansson, Chief Operating Officer Alvotech

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