How new technology in the field of loading & unloading systems for pharmaceutical freeze-drying processes allows freeze-dryer cold shelf loading whilst managing different formats of containers and recipes without decreasing the loading speed. By incorporating new frictionless magnetic drive technology, a new freeze dryer vial automatic loading/unloading system with the ability to have CIP/SIP inside chamber which has proven to successfully ensure a peak performance in production. Lyogistics Zero is a new system developed by Telstar that not only provides unprecedented levels of technical precision and robustness, but also actively contributes to maintain integrity of the freeze-drying process and product under full aseptic conditions. This case study shows how the implementation of this new system effectively responds to high demanding specific challenges.

Challenge

This Contract Manufacturer had the need to work with several different products, container’s formats and recipes. When planning to increase the production capacity for lyophilized products for one of his existing customers, the demand was to be able to produce high value products requiring cold shelf loading, different formats and high loading speed due to the instability of the solution in liquid form.

Solution

Telstar in its commitment to solve the customer’s challenges offered a loading and unloading system able to fulfil the URS:• Cold shelf loading without decreasing the high nominal loading speed• Flexibility to handle different formats of containers• Robust fail mode in case of unexpected issues during loading or unloading

Results•

Zero decreasing speed when cold shelf loading• Total flexibility to handle different formats of containers from 2 ml up to 50ml with no change parts in de loading/unloading module (only in the line). Other types of containers also possible• No human intervention needed inside the barrier system (RABS or isolator) in case of fail