ENG Custom Made GMP Freeze Dryer Pharma Production Equipment > GMP Freeze Dryers > Custom Made GMP Freeze Dryer The LyoMega range covers the most demanding freeze drying integrated and customized solutions for pharmaceutical production. Telstar offers design flexibility to address the requirements of each project. Customization capabilities cover a wide range of engineered solutions, including two-door pass-through design and sub-doors for product loading and unloading at a constant level. Internal or external condenser systems can be in horizontal or vertical configurations and can be positioned adjacent to or below the chamber. Refrigeration systems range through double stage or cascade reciprocating compressor, screw compressor or liquid nitrogen and a full range of customised CIP systems is available. Previous Next Download Data Sheet Download Brochure Project Management Each project is handled by a project team consisting of a project manager that coordinates communication between the customer and the rest of the project team; a mechanical engineering team, a control engineering team, a validation engineering team and a manufacturing and logistics team. Telstar’s in house expertise and manufacturing capabilities in isolation technology solutions facilitates a perfect integration of systems for containment or aseptic applications. Durable Construction The main components treated as Product Contact Surface, chamber and doors, freeze drying shelves, condenser and process pipe work are constructed in stainless steel AISI 316L for optimum 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. Safety and Ergonomic Design for Users 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. High versatility of the control systems 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. Design for GMP The shelves, chamber and door inner surfaces are mechanically polished to Ra ≤ 0.51 μm as standard, with the longitudinal edges rounded to facilitate cleaning. Options to other roughness are also available. Piping joints are orbital or TIG welded. Removable connections are preferred, 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. An air differential seal separates the technical area from the cleanroom or contained laboratory. Several refrigeration solutions In our innovation plan, we work together with the customer to offer solutions in order to find the most suited refrigeration systems that are tight to the context. These solutions come from double stage or cascade reciprocating compressor, screw compressor or liquid nitrogen. Wide range coverage LyoMega range models cover a broad range of production surface from 3.5 sqm. The large array of configurations allows manage several formats of production such as bulk, vials (row by row or allocated in trays), syringes, ampoules… The management of these different formats is solved with solutions as manual, semiautomatic or completely automatic loading and unloading systems. See more about loading and unloading systems… Safety in Redundancy: It’s important to have backups? The LyoMega units ensure to integrate a high flexible modular redundancy and a consistent, efficient safety concept in plants with high safety requirements. 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 freeze dryer system offers the Flexible Modular Redundancy. This means the customer choose the redundancy levels considering fitting the safety of the process. The infinite personalization options render each LyoMega unique The main goal of industrial freeze dryers is to eliminate solvent (normally water) from a solution, without causing damage or change to the properties the solute, so that it can be readily reconstituted. Base Industrial freeze dryers include the following important components: Chamber Freeze drying shelves Condenser Air inlet installation Vacuum installation Refrigeration installation Each of these installations can be personalized under customer specifications and pre designed to be configured to any given application, thereby offering great flexibility within realistic cost and delivery deadlines. These are just some of the options customer might select configure the freeze dryer. Vial stoppering system Constant height loading system Slot door for loading and unloading CIP cleaning system with detergents dosing unit SIP sterilization system Automatic venting filter integrity test Vacuum group with dry pumps Redundant critical components Feedback position valves LyoGistics automatic loading and unloading systems Integration with isolators or RABS systems Qualification service Equipment configuration configured according to the features of the customer’s room LyoMetrics monitoring tool LyoNuc vacuum induced nucleation See more about LyoNuc… LyoSensing In-line process analyzer See more about LyoSensing… Control architecture configurable according to customer requirements Freeze drying cycle development support laboratory Preventive maintenance programs Upgrades and refurbishment Single vessel. Condenser located inside the chamber Pass-through design for loading and unloading at different cleanrooms Horizontal or vertical configurations with chamber, condenser or auxiliary offshore skids. Solvents and high potent products An intended product to work in any part of the world Telstar understands the geographical differences around the world and the necessities of the market; therefore the LyoMega range ensures a flexible design that adapts the product to the context. PED ASME UL Frequency and voltages Seismic code Diverse field of applications For either bulk format or liquid in vials, ampoules or syringes, the LyoMega units are designed for freeze drying high value products, such as: Vaccines Cytostatics Antibiotics Biologicals Hormones Active ingredients Reactives The quality in the raw materials reflects quality in the final product The main components treated as Product Contact Surface, chamber and doors, freeze drying shelves, condenser and process pipe work are constructed in stainless steel AISI 316L for superior 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 and so, are of a high 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. Telstar freeze dryers include as standard the new Sapphire Capacitance Diaphragm Gauge, manufactured by the parent company AZBIL GROUP, as an innovative solution keep the zero point from shifting. The sensor is specially thought to avoid the zero point to shift that affects the controllability and thus the quality of the final product. See more about Sapphire… Telstar Value Services We work alongside our customers in close partnership, supporting them throughout the full life cycle of their plant and equipment to ensure lasting business success. 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