Telstar Presents PAT Tools for Freeze Drying and Aseptic Manufacturing at Achema 2018

Telstar will be showcasing its latest solutions for the biotech and pharmaceutical industry at Achema (June 11–15, 2018, Frankfurt, Germany). Telstar has a dedicated process analytical technology (PAT) corner at its booth to display developments in the PAT field for pharmaceutical freeze drying systems and aseptic manufacturing processes. 

The company will be introducing its new sapphire capacitance diaphragm gauge to the freeze drying market for the first time. It is a sensor to measure vacuum in steam sterilizable GMP freeze dryers with the ability to provide higher levels of stability and resistance to the cycling between vacuum and pressure, resulting in a good zero stability compared to existing gauges in the market. This eliminates the need for periodical zero drift adjustments.

The PAT corner will be also display a steam quality sensor to measure in-line steam dryness and the degree of superheat of the pure steam used in sterilization processes, thus allowing the continuous monitoring of such a crucial supply. In the field of cleanroom environmental monitoring and operation, the technological set will integrate an IMD-A system for air instantaneous microbial detection that, using an optical technology, is capable of simultaneously detecting both size and biologic fluorescence of airborne particulates. 

Telstar will also showcase a smart heating, ventilation, and air conditioning (HVAC) control system for cleanrooms. The monitoring and controlling capability allows the system to reduce the frequency of air renovation cycles and to reach the maximum level permitted of particles in the room in accordance with GMP classification, while saving more than 40% in energy consumption depending on the room operation and use.

The new Lyonuc, a nucleation induction method developed by Telstar for freeze drying, will also be presented and demonstrated. Themethod reduces the duration of the primary drying cycle and ensures the uniformity and homogenization of the vials in all the batches, without affecting the product’s morphology and physiochemical properti.

Another innovation that will be promoted at Achema is the Lyogistics Zero, an automatic vial loading and unloading system for freeze-dryers, which can be cleaned and sterilized in place inside the freeze-dryer chamber. Suitable for use in production processes involving hazardous products, Lyogistics Zero has been designed to be integrated within aseptic isolators requiring high-level protection for the operator, the product and the environment.

Source: Telstar, Hall 3.1, Booth C49