Labscale Production GMP Freeze Dryer

The focus of new drug development is increasingly on biotechnology and biopharmaceutical products with a high value targeted to a specific population for the treatment of more rare and complex diseases. As science advances, the R&D process must evolve to address new requirements. This adds complexity to the drug development process and in turn influences process equipment. This factor is currently driving an increase in the proportion of new drugs produced aseptically and lyophilized, a reduction in the size of the batches and an increase of the application of barrier technologies and automation to separate potent but delicate products from human operators. Telstar Lyotris is a cGMP small-scale freeze dryer suitable from early research stages to production stages in vials or bulk under aseptic conditions. It is particularly suited to clinical and small production scale batches of highvalue pharmaceutical products such as personalised drugs and pharmacogenomic treatments, vaccines, antibodies and other advanced drugs and therapies which require stabilization. The standard version includes the complete systems required for automatic cleaning (CIP) and steam sterilisation (SIP) processes and filter integrity testing (WIT). The unit offers critical component redundancy for elements such as the vacuum pumps, compressors and the heat transfer fluid circulation pump. The Lyotris standard unit includes a hydraulically actuated piston to move the shelves for stoppering and a displacement transducer that enables a fine positional adjustment of each shelf to a predetermined loading height for integration with automatic loading and unloading systems. The basic unit is supplied with a stainless steel front fascia for integration through the wall of a clean room or and aseptic isolator and also incorporates an advanced SCADA system for control, supervision and data acquisition. The comprehensive documentation package includes operation and maintenance manuals, as built drawings and material and instrumentation calibration certificates as standard.

Read more

Lyotris combines industrial equipment specification and performance and small batch flexibility in a compact envelope. Lyotris is a labscale production freeze dryer especially designed for production of small batches of high value pharmaceutical products. It is suitable for freeze drying high potent products that require containment. The Telstar Lyotris freeze dryer has a 1m2 loading surface and capacity for approximately 1,600 10R-type vials or 30 litres of bulk product. It has been specifically designed for aseptic production in vials or in bulk and its novel fascia and door design provides easy isolator integration.

AZBIL TELSTAR BANGLADESH LTD.

AZBIL TELSTAR BANGLADESH LTD.
Manufacturer
Bangladesh

Primary focus area

Injectable / Sterile Unit

Analytical Products & Services

Project Management / Consultants

Add to Favourite
Book a Demo