Telstar will be exhibiting the latest developments in aseptic technology for pharmaceutical production in GMP at the PharmaTechnica exhibition, which takes place in the framework of the Pharma Congress event (Wiesbaden 2024, 19-20 March).
The company will be deploying a compelling portfolio of solutions in the field of process equipment & integrated solutions in isolation technology systems, sterilisation and freeze-drying applications covering the complete phases of a pharmaceutical manufacturing process.
Telstar will be promoting a new dual mode Isolator system capable of operation for either containment or aseptic purposes.
With the ability to handle various processes in one unit, it reduces the need for excessive equipment and creates a more efficient use of available space.
In addition, the unit being dual mode is a cost-effective solution, reducing the need for multiple isolators in some cases.
Aimed at the pharmaceutical, biotech, healthcare, cell therapy and veterinary markets, the system integrates a total of 6 operational modes to manage the operational requirements: maintenance mode for setting up and checking over the machine parameters, pressure hold mode to ensure air is not escaping the system for biodecontamination purposes and that the isolator is sealed, biodecontamination mode to reduce the bioburden within the chamber by log six, non-sterile / potent API mode, sterile potent API recirculation mode and, finally, non-sterile potent API nitrogen mode.
The Telstar system is integrated with Telstar’s innovative ionHP+ bio-decontamination system proven to dramatically decrease cycle times, increase time available for process and reduce running costs, using an 8% hydrogen peroxide solution, delivering a nebulised mist into the chamber this keeps the ppm levels low whist still delivering a 6-log reduction in bioburden.
New Telstar's developments in the field of isolation & barrier systems technologies respond to increasingly demand for larger aseptic filling line Isolator system and sterility test isolators.
The current trend responds widening restrictive regulatory demands, less reliance on cleanroom technology and a need for greater sterility assurance.
Lyogistics Smart Format
At Pharma Congress, the company will also be promoting new developments in both in line management devices and process analytical technology for pharmaceutical freeze-drying
systems such as the Lyogistics Smart Format.
It is an innovative automatic format change system for the transportation of freeze-drying vials that uses a single mobile platform configured to automatically fit a wide range of vial sizes without the need to disrupt the isolated enclosure.
There is no need for manual operations inside the aseptic area when changing formats, and no line clearance operations are required.
Xavier Gomez, Product Manager at Telstar will be presenting the Lyogistics Smart Format within GMP Pharma Congress Conference.
He will address the issues in setting-up an automatic line to load and unload GMP freeze dryers with multiple formats under isolation technology, as well as the procedures to introduce multiple formats, cleaning, sanitisation, and line clearance.
He will also analyse pros and cons of having multiple formats ready to use inside the isolator versus the introduction of formats at the time of use, in addition of risks of contamination.
This presentation is programmed within the session on Lyophilisation and Modern Techniques & New Requirements which will take place on 19 March between 15:45 – 16:30.
