Aseptic Transfer Isolator, a brand new solution by Tema Sinergie for the transfer of low temperature liquid substances

19 January 2023

The Aseptic Transfer Isolator (AP-IS Series) is specifically designed to comply with the needs of liquid material transfer from a Class A environment to any external fluid collector tank.

 

The Aseptic Transfer Isolator is a brand new custom isolator system for pharmaceutical companies requiring a low rH% value aseptic environment for the transfer of liquid substances.

This isolator is composed of a single working chamber, integrated with our HYPER bio-decontamination system and monitoring detectors for H2O2 levels, a Rapid Transfer Port DPTE®, a SART® port and a Flexicon® peristaltic pump.

Liquid transfer is the main requirement; it should however be also considered that the very substances entering the isolator have different temperatures, mostly very low, around 0°C.

After the bio-decontamination cycle with VPHP (which acts at a temperature of about 35-40°C), a relevant peroxide residue is expected to affect both the isolator and its load. For viruses used for the development of vaccines, getting in contact with condensed VPHP is enough for the whole process to be jeopardized.

A solution was found by developing an advanced ventilation system with an integrated dehumidification unit. Upon completion of the bio-decontamination cycle, a flow of conditioned hot air runs through the chamber (at very low relative humidity and high flow rate), which dries and quickly removes the residual H2O2 up to the threshold value of 1 ppm.

 

 

An easy and customized workflow for the operator

The workflow has been designed to meet the strict needs of the customer, and structured to make each phase as simple as possible. Our know-how and the high engineering value of our isolators allow us integrations and customizations pliable to all types of aseptic processes.

It takes just 6 steps to carry out a single cycle of this process:

Insertion of the load inside the isolator: vials filled with liquid substances and accessories required for the process, including kits for emptying the vials;

Carrying out an automatic leak test lasting about 10 minutes;

Performing a bio-decontamination cycle of approximately 50 minutes at 6-log;

Installation of the kit on both the peristaltic pump (outside the chamber) and the SART® system;

Emptying of all vials in the external tank. The operator empties the vials at a speed of 1 liter every 15 seconds thanks to the Flexicon® pedal-activated peristaltic pump;

After all vials are empty, run a 4-log bio-decontamination cycle and remove the load (until the nex session).

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© 2024 TEMA SINERGIE S.p.A
Reg. Impr. di RA, C.F., P.IVA, VATn. IT00970310397
Iscr. Reg. Imprese di Ravenna n. 00970310397  |  R.E.A. 111877
RAEE IT08020000002755
Capitale Sociale € 2.000.140,08 int. vers.