Telstar has extended its range of freeze-dryers with the launch of a cGMP unit suited to clinical and small production scale batches of high-value pharmaceutical products under aseptic conditions. The unit is suitable for the freeze-drying of high potency products that require containment in addition to those for biological, biotechnology and biopharmaceutical applications.
The Telstar Lyotris is scaled to enable its use for the development of new products, clinical trials and small production batches. Designed using in-house technology, the compact freeze-dryer combines industrial equipment specification and performance and small-batch flexibility.
It has a 1m2 loading surface and capacity for approximately 1,600 10R-type vials or 30 litres of bulk product. It has been specially designed for aseptic production in vials or in bulk and its novel fascia and door design provides easy isolator integration. The standard version includes the components required for automatic cleaning (CIP) and steam sterilisation (SIP) processes and filter integrity testing (WIT). The Telstar Lyotris freeze dryer can be supplied on two separate skids to facilitate transport through facilities and installation flexibility.
The unit offers critical component redundancy for elements such as the vacuum pumps, compressors and the heat transfer fluid pump. The equipment also incorporates an advanced SCADA system, which includes Telstar’s patented DPE system, providing advanced real-time information on the freeze-drying process.
Developed in response to the ever-increasing demand from the pharmaceutical market for high-value medicines aimed at specific population groups and requiring small-scale production under aseptic conditions, the Lyotris is particularly suitable for products for biopharmaceutical and biotechnology applications such as personalised drugs and pharmacogenomic treatments, vaccines, antibodies and other advanced drugs and therapies which require stabilisation.
