All systems and equipment fulfil the most stringent requirements with regard to the materials used and functional safety, and they are extensible and upgradable for future applications. Advanced automation concepts simplify operation for users and ensure fully reproducible drying processes. Our experts are active in major associations and working groups, including ISPE and the German PAT group, and are therefore familiar with stringent regulatory requirements, particularly with regard to the pharmaceutical and biotech industries.
We work with users to devise system and loading concepts for an extremely wide range of tasks and process requirements and implement them in manufacturable designs.
The double-chamber design developed by Christ places the ice condenser directly below the drying chamber. There is a wide choice of sizes, with ice condenser capacities from 12 kg to more than 500 kg.
The shelf area ranges from 1 m² (specifically for process optimisation) to over 40 m², depending on the system type.
Cleaning in place (CIP) is a validated automatic cleaning process for production units.Our production freeze dryer systems enable optional cleaning processes due to
the special design with the ice condenser below the drying chamber, which allows the CIP piping and nozzles to be positioned optimally.
The CIP process can be adjusted in the LPCplus process visualaistion system very flexible by the operator according to the process requirements.
The cleaning of the ice condenser and drying chambers and the shelves is verified by a riboflavin test.
The purpose of the sterilisation process is to sterilise the drying and ice condenser chambers, including all chamber fixtures and piping systems of the freeze dryer that
come in contact with the product.
This requires sterile steam, which is provided by the user or plant operator.
The course of the actual sterilisation process can be adapted to specific customer needs, and it is controlled and documented by the LPCplus control software.
The filter integrity test (FIT) checks the integrity of the sterile filter at regular intervals. The steam-sterilisable freeze dryers from Christ have fully automatic
filter testing already integrated in the automation system. The water necessary for the filter test is generated in the unit from sterile steam, and the test results
are documented by the LPCplus process control system.
The standard version is equipped with a sterile filter, and on customer request a second sterile filter can be fitted in series. This does not affect the fully automatic filter test process.
For an automated loading and unloading solution of a freeze dryer a slot door in the clean room area is required.
The loading and unloading of the freeze dryer is done with a constant loading level to allow direct connection to a filling line.
The optimal, well designed Christ-solution is a very compact construction, which is easy to be cleaned as well. This offers advantages
specifically for isolator solutions and automated push-pull systems.
Typically the freeze dryer is equipped with a slot door in the clean room and a swing door in the machining area, also door-in-door
solutions are possible.
With a slot door the freeze dryer could be easily connected with an isolator or an glove box.
The product range of the Martin Christ Company has been expanded to include the new, patent-pending LyoShuttle automated loading and unloading
system. The freeze-dryer is loaded by a loading robot that uses timing belts to move horizontally.
The loading robot moves on a set of rails mounted at the constant loading level alongside the shelf set. Motive force is provided by battery-powered
stepper motors. The batteries are charged wirelessly when the robot is in the parked position in front of the freeze-dryer. The loading robot communicates
wirelessly with the controller.
Thanks to its flexible and space-saving construction, the LyoShuttle option is particularly suitable for production freeze dryers in the pharmaceutical field,
including under insulated conditions, and requires significantly less space.
Many common systems have an unloading bar that moves above the vials filled with the product. With the LyoShuttle system from Martin Christ, the shelf package is raised a few centimeters to allow unloading of the vials. The integrated unloading beam of the LyoShuttle moves beneath the loaded shelves to a parked position behind the shelf package. The shelf to be unloaded can then be moved to the unloading height (constant loading level). With LyoShuttle, there is never any moving part above the vials filled with the product, even after capping. Conclusion: In summary, with the LyoShuttle, we only move in front, behind and beneath the vials.
With most of the usual push-pull systems, up to 50 mm of additional space above the capped vials – for each shelf – is necessary for unloading freeze dryers with an unloading bar. This makes the freeze dryer 50 to 100 cm higher than usual, significantly increasing production costs. The unloading bar of the LyoShuttle system moves below the shelves loaded with vials. No additional space is necessary above the vials, so the freeze dryer can be made lower.
All GMP aspects have been consistently taken into account in the design of the LyoShuttle system. Particular attention has been given to compact construction for use in isolators or LAF units, along with good accessibility and excellent cleaning capability. Service-friendliness was also given special attention as the design was developed.
With LPCplus, we offer a comprehensive automation solution for process visualization and documentation, which we have further adapted for LyoShuttle. All processes can be visualized, operated, and documented continuously from loading and unloading to freeze drying. Of course, integrated solutions for insulation technology and filling lines are no trouble at all with our open and flexible solution approaches, and have already been proven in practice many times over.
For the first time in a fully automated loading and unloading system, we offer redundant system components in order to ensure system availability with cGMP compliance, even in critical situations. For example, electrical, rechargeable batteries, and charging stations are designed to be redundant. All systems are sized to be able to support full cycles. The redundancy thus significantly improves the availability of the system.