Active Bio-decon Walk-In Pass Through Chambers
Le Active Bio-decon Walk-in Pass Through Chambers sono pass box che consentono un trasferimento asettico di materiali all’interno delle cleanroom.
I materiali sono sterilizzati all’interno delle Pass Through Chambers per mezzo di un sistema di Bio-decontaminazione integrato.
Tema 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.
Chief Operating Officer
Alvotech
The AB-PTC assures the highest air quality of the isolated environment thanks to:
– an engineered filtration system composed by High-Efficiency Particulate Air (H14) flow and exhaust filters;
– HYPER, Tema Sinergie’s integrated Vapour Phase Hydrogen Peroxide (VPHP) bio-decontamination system for very fast bio-decon cycle
– inflatable seals made of FDA-approved White Silicon
The integrated ventilation system of the chamber guarantees a pressure cascade between the adjoining rooms and the chamber itself. This cascade preserves the asepsis of the materials after the termination of bio-decontamination process prior to extraction into the cleanroom.
Maximizing operator protection is a key feature when handling BSL-1 through 4 organisms. AB-PTC assures the maximum safety thanks to the following features:
– HYPER, an integrated VPHP system for the decontamination of materials prior to extraction from the BSL facility
– pressure control strategy to prevent back flow of air the BSL and non BSL boundaries.
– bio-sealed doors and sheathings to avoid any leak between BSL and non BSL boundaries.
The AB-PTC is therefore the perfect adaptable solution to decontaminate equipment/materials prior to taking it out of a BSL facility, to avoid leak of potentially hazardous organisms towards the external areas.
The AB-PTC is equipped with a routine automatic leak testing system which performs an independent leak test cycle for each chamber according to the pressure change method (5.2) ISO 10648-2:1994(E).
A remote control module made of AISI 304 stainless steel, containing electrical and pneumatic components, allows direct access for all maintenance operations.
A Virtual Private Network (VPN) connection allows a secure and private communication via Internet network and provides remote access and assistance, updates and maintenance any time, everywhere.
AB-PTC is available in different standard dimensions, including Walk-In models.
The AB-PTC can also be upgraded with an Integrated Supervisory Control And Data Acquisition (SCADA) – iFIX with Historian Data Management Software (DMS) from GE Digital.
DataWall, a software application developed by Tema Sinergie for data management, is also available upon request.
Thanks to the new sustainable low voltage ventilation fans, the isolator has a very low energy consumption throughout its life.
Il sistema di ventilazione integrato garantisce un gradiente pressorio tra i due ambienti adiacenti e la Pass Through Chamber stessa.
Questa cascata pressoria preserva l’asepsi dei materiali dopo il termine del processo di bio-decontaminazione, prima dell’estrazione del materiali all’interno della cleanroom.
Progettata su misura per adattarsi alle singole applicazioni.
