Freeze Dryers
With more than 50 years’ experience in this field, Telstar has become specialised in the design of GMP freeze drying , centred on process control, sterility and product loading and unloading automation aspects.
Telstar provides turn-key custom-made solutions with clients to develop the most appropriate solution, offering reliable and trouble-free process technology. To ensure the equipment fully satisfies requirements, Telstar undertakes factory acceptance testing (FAT) of all freeze-dryers, simulating as closely as possible real working conditions.
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.
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…
Loading & Unloading GMP Systems
Telstar offers a complete range of freeze-dryer loading and unloading systems designed to cover a broad range of applications; whether production is in bulk, vials or other types of containers. The range extends from manual-assisted devices through to semiautomatic systems and fully automatic solutions.
Telstar solutions are tailored to customer needs and product requirements, taking into account capacity, number of freeze-dryers and production conditions. The different solutions can range from robotized systems for the direct loading and unloading of bulk product onto shelves, fully automatic loading and unloading systems with product in trays, automatic vial loading and unloading systems without trays, using a ‘fixed’ row-by-row or shelf-by-shelf with a moving vehicle.
What is the optimal solution?
The most suitable loading system, defined in terms of cost and performance will depend on the number of freeze-dryers, process speed, range of containers to be used, clean room/isolator classification, freeze-drying cycle duration, distance between the freeze-dryer and filling and capping equipment and other process flow parameters.
The ‘fixed’ systems that load vials row-by-row are usually the most suitable for up to three medium to large size freeze-dryers, as their integration with close RABS and isolators is generally easy. Shelf-by-shelf mobile systems are generally more suitable for several large freeze dryers with open RABS.
Modular GMP Freeze dryer
The LyoZeta freeze dryer series are designed to perform clinical trials, pilot and large scale industrial freeze drying processes, in accordance with the strictest GMP and regulatory standards and in line with the latest freeze drying technology trends.
Telstar LyoZeta Series are state of the art freeze-drying systems, designed and engineered modularly to provide a comprehensive range of standard models and in-factory options. The LyoZeta Series constitutes a well-proven standard solution and provides the right balance between specification, quality, cost and lead-time.
A complete and reliable base unit
Each LyoZeta is configured as a compact unit in mono-bloc configuration that can be installed through the wall of the sterile room while offering easy maintenance access to all elements and optimizing the total space necessary.
The base unit has the following features:
- It covers freeze drying areas from 4 m2 to 50 m2.
- Rectangular chamber manufactured in AISI 316 L stainless steel.
- Horizontal cylindrical condenser manufactured in AISI 316L stainless steel, which can be located behind or at the lateral side of the chamber.
- Cartridge mushroom valve or butterfly valve to isolate the condenser and the chamber. See more about cartridge mushroom valve…
- The internals of the chamber-condenser group are polished and have a self-draining design to promote effective cleaning and sterilization.
- The door is constructed in AISI 316L, with a sight-glass in the centre to observe the product during the cycle.
- The equipment installations are designed according to the end user’s requirements. The Mechanical refrigeration and vacuum system can be dry or oil-sealed, with or without redundancy.
- Telstar freeze drying inner channel design shelf ensures high product homogeneity during the freezing and primary and secondary drying stages.
- Loading and unloading systems to manage different formats of production. Solutions as manual, semiautomatic or completely automatic system. See more about loading and unloading systems… (INTEGRAL)
- OEM components from first brands widely available in the marketplace. Valves, filters, measuring instruments and other components are of a high quality and provide state of the art technology.
- The freeze dryer system offers the possibility to select modular redundancy. This means the customer is able choose the redundancy levels, considering redundancy on the main installation such as refrigeration or vacuum groups.
Control Systems. User-friendly solutions for maximum efficiency
The SCADA supervisory, control and data acquisition system designed by Telstar, allows the user to readily interpret the machine’s operation and obtain information on the process required for decision making and batch reporting, all in compliance with FDA 21 CFR part 11 electronic record guidelines.
Designed thinking on GMP
Main components such as the chamber, freeze drying shelves, condenser, and process pipe work are constructed in stainless steel AISI 316L and are mechanically polished to Ra ≤ 0.51 μm as standard. Sanitary fittings are sealed with pharmaceutical grade gaskets and piping joints are orbital or TIG welded.
Technical guidance and fluent communication
The project is handled by a project manager that coordinates the communication between the customer and the rest of the project team, who are experts in mechanical, control, validation and manufacturing.
Wide field of applications
For either bulk format or liquid in vials, ampoules or syringes, the LyoZeta units are designed for freeze drying high value products, such as:
- Vaccines
- Cytostatics
- Antibiotics
- Biologicals
- Hormones
- Active ingredients
- Reactives
Accessories & Options
When engineering modular systems, the standard model range Telstar offer will provide the most appropiate solutions to meet the most common requirements and challenges in the industry. A comprehensive number of options have to be adapted to match the particular needs of the customer.
- Vial stoppering systems
- AISI 316 stainless steel bellows for stoppering ram isolation
- Constant height loading system
- Automatic door latching and locking system
- Sub-door for loading and unloading
- CIP cleaning system
- SIP sterilization system
- Vacuum group with dry pumps
- Redundant critical components
- Product trays
- Qualification service
- Freeze drying development support laboratory
- Preventive maintenance programs
- Calibration series
- Training services
- Upgrade & Refurbishment
- Solvents and high potent products
Contactless Loading & Unloading System
Telstar offers a complete solution of freeze-dryer loading and unloading systems designed to handle different products and format production containers such as vials (row by row or allocated in trays with or without bottom), bulk trays, single−use disposable containers, nest for syringes or ampoules…
Telstar solutions are tailored to customer needs and product requirements. By incorporating contactless magnetic drive technology, Lyogistics Zero is able to minimize the presence of particles that comes from the mechanisms and electrical accessories, which are typically used in conventional systems, allows loading at maximum speed under cold shelf loading conditions, and in case of failure allows the system to run in manual mode to avoid opening the system and losing the production batch. The development integrates a cleanable and steam-sterilizable slider with no concealed parts which is moved by a contact-free magnetic drive. mechanism.
No pushers, no bellows, no batteries, no mechanisms inside chamber
The contact-free magnetic drive mechanism is an autonomous passive slider without motors, batteries or cables inside the chamber.
The movement is transmitted to the system by means of a magnetic screw without the necessity of cables, racks, belts, bands or linkages to move the carts.
System able to load pre-frozen products into the freeze dryer at 600vials/min
It is a common way to handle pre-frozen products and load them into the freeze dryer where shelves are colder than the room temperature, sometimes at work temperatures of minus 20 ºC and even minus 40ºC.
These cold loading temperatures usually cause issues such as condensation and even frost on the lyo shelves, creating an insulation layer between the product container and the shelf. Therefore this means there is no direct contact with the shelves, generating longer loading times and possible fallen vials due to the ice formation and longer freeze drying cycles.
The challenge to load pre-frozen products without reducing the loading speed is solved by the frictionless magnetic system Lyogistics Zero that offers an efficient way to load vials onto precooled shelves without decreasing the loading speed and keeping a rate of up 600 vials/min.
The result is achieved as the magnetic slider does not need a pusher to load the vials and while some rows are being ready to be loaded, other rows are being transported into the freeze dryer. The wireless solution avoids the interference between the pusher that loads the rows until the end of the shelf and the new rows formed.
Flexibility to handle different formats in the Pharmaceutical industry
The Pharma industry requires protection for the most varied applications. An established market of different customized applications requires that the same freeze dryer works with different kind of formats.
The large array of configurations allows managing several formats of containers such as
- Vials (row by row or allocated in trays or frames)
- Bulk trays
- Single−use disposable containers
- Nests for vials, syringes or ampoules…
And one of the important advantages is that it allows frames and trays to link without the necessity of pins or dedicated tools.
Simulation of working conditions
Integrating various core technologies, Telstar provides turn-key custom-made solutions to solve customer’s most challenging applications. To ensure the equipment fully satisfies the user requirements, Telstar undertakes factory acceptance testing (FAT) of all loading and unloading systems, simulating as closely as possible the working conditions with customer format containers.
In essence, excellent engineering coupled with efficient manufacturing and business practices provides high quality solutions and superior value. Telstar is constantly developing solutions to address the emerging challenges in pharmaceutical freeze-drying technology.
Cleaning, sanitization and sterilization compatibility
Cleanability and sterility testing of sterile pharmaceutical products is required by the Pharmacopoeias to determine acceptability of a production lot.
Telstar’s Lyogistics Zero is a unique loading unloading system integrating a slider cleanable and sterilizable by steam inside the chamber. Steam sterilization is widely used for sterilizing freeze drying chambers because it doesn’t need special chemicals and the process takes less time than other methods. The slider doesn’t need any wiring for control such as a power cable or signal cable and it can stay in the chamber when the chamber door is closed. The slider is composed of such material as stainless steel and FDA approved plastic parts that have good temperature and corrosion resistance characteristics. Therefore the slider can sustain chemical cleaning and steam sterilization processes.
Many automatic loading unloading systems are manually cleaned by the operator but this is a heavy labour. There is also a risk of something unwanted remaining in the system, depending on the ability and tools of the operator. By allowing the automatic cleaning and sterilization in place helps keep the quality to a high standard and it also removes the hard work from the operator.
The correct solution is to build all components in stainless steel AISI 316L for better resistance to stress fatigue and corrosion and reduce the presence of components in the working area as much as possible.
The main components treated as Process Contact Surface like load/unload bars, bridge plates and conveyors need to resist stressing fatigue and corrosion and are fully compatible with cleaning and sterilization products such steam, hydrogen peroxide and other chemical products.
All loading and unloading systems are fully compatible with cleaning and sterilization products and methods such as hydrogen peroxide and other chemical products*
*For a material compatibility study please contact the Telstar technical department.
Compact layout
The process conditions pre-determine the environment where the loading system is placed.
Depending on the product to be freeze dried, containment/aseptic technologies such as Laminar Airflow systems (LAF), aseptic/containment Isolators and Restricted access barrier systems (RABS) needs be integrated providing greater product, operator or environmental safety technology.
The complexity of the loading system determines the size and layout of the barrier system and the clean room layout required.
The magnetic wireless system is able to load and unload with the necessity of long pushers. It uses a reduced stroke front pusher and removes the need for a rear pusher.
The use of a new reduced front pusher allows the whole system to inside the containment and reduces the risk of leaks.
The presence of long pushers at the loading or unloading side will require bellows across the RABS and isolators walls to keep the sterility inside the containment.
The advantage is to have all the system inside the contained/aseptic environment thereby reducing the risk of leaks and thus potential contamination.
In terms of integration with barrier systems the solution implemented using the magnetic slider reduces the front pusher length and removes the rear pusher. That makes the system compact which is reflected in the need for a smaller cleanroom layout, easy access and good visibility in the surrounding work area. This provides users with improved workability and flexibility of the overall layout.
Robust failure mode solution
Typically, when a loading and unloading system fails, the mechanical intervention from a maintenance team is needed. When a push system by means of a pusher or belts fails, assistance is required to open the barrier system in order to make the intervention. This means the sterility of the system is broken and the batch is lost. In addition, the person will be in contact with the product, which is an important risk factor.
In case of failure mode, the Lyogistics Zero allows control of its movement from outside of the containment. The motors that move the magnets screws are outside the sterile area, and are capable of being moved by hand or replaced without breaking the sterility. Their movement can be forced to raise a certain position. This means, in case of failure, the load/unload of the production batch could be finished whilst keeping the integrity of the product.