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.
The compact technical area is designed to save space but keeping in mind ease of maintenance, allowing access to components and replacement of spares. Potential hot piping is insulated.
Refrigeration and fluid skid is an independent unit connected as standard to the main skid but allows its relocation and gives flexibility when the technical area requires it.
The unit offers critical component redundancy for elements such as the vacuum pumps, refrigeration system and the heat transfer fluid pump.
Safe and fault-tolerant controllers monitor themselves autonomously. When a fault occurs they immediately switch to/remain in safe mode or, in the event of a hardware failure, automatically switch over to the redundant system.
The main components treated as Product Contact Surface, such as, chamber and doors, freeze drying shelves, condenser and process pipe work are constructed in stainless steel AISI 316L for greater resistance to stress fatigue and corrosion.
Doors seal by means of a special silicone gasket which does not require permanent lubrication and all process valves are diaphragm type.
The OEM components like valves, filters and measuring instruments are of the highest quality and state of the art technology. They are sourced from first brands widely available in the marketplace. Full material certificates, instrumentation calibration certificates are traceable to national standards and certificates of conformity are provided.
For either bulk format or liquid in vials, ampoules or syringes, the Lyotris units are designed for freeze drying high value products, such as:
The unit is supplied with our complete SCADA control system Lyosuite™.
Lyosuite™ is a Supervisory Control and Data Acquisition (SCADA) system integrated with an innovative suite of process tools that combines the proven robustness of industrial PLC control with the security of a widely available SCADA package and integrates a suite of tools for advanced process monitoring.
Engineering practices are consistent with current Good Automated Manufacturing Practices (cGAMP) and result in a precise, stable control system that comprehensively addresses a client’s process control and validation requirements.
The Lyosuite™ system offers multitasking operation in a Windows® environment. In addition to the supervisory control and data acquisition functions, it provides compilation and editing of complete recipes, including linking of ancillary cycles (CIP, SIP, filter integrity testing or vial stoppering) to the freeze drying cycle. Help is interactively provided through pop-up windows.
Customized control architectures are available to provide redundancy or to integrate them with a client’s IT infrastructure, depending on client’s policies and specifications.
Telstar Lyotris is 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 Lyotris is scaled to enable its use for the development of new products, clinical trials and small production batches.
The product contact surfaces are mechanically polished to Ra ≤ 0.51 μm with the longitudinal edges rounded to facilitate cleaning. Piping joints are orbital or TIG welded and with in-line sanitary fittings sealed with pharmaceutical grade gaskets.
All process pipes are constructed in stainless steel AISI 316L and keep slopes towards the drainage. Dead legs are minimised to avoid fluids stagnation.
Telstar understands the geographical differences around the world and the necessities of the market. With that in mind the Telstar Lyomega range ensures a flexible design that adapts the product to the context.
The main goal of a freeze dryer is to eliminate solvent (normally water) from a solution, without causing damage or change to the properties of the solute, so that it can be readily reconstituted.
Telstar’s Lyotris Base unit include the following important components:
The standard version also includes the components required for automatic cleaning (CIP), steam sterilisation (SIP) processes and filter integrity testing (WIT).
In addition the equipment incorporates an advanced SCADA system which includes Telstar’s patented ‘Lyometrics’ system; providing advanced real-time information on the freeze-drying process.
Other features included are:
To complete the product, the customer can select the following options:
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