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.
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.
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.
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
And one of the important advantages is that it allows frames and trays to link without the necessity of pins or dedicated tools.
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.
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.
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.
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.
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