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OPTIMA GROUP pharma: Line for vials with lyophilization downstream

OPTIMA GROUP pharma: Line for vials with lyophilization downstream

OPTIMA GROUP pharma: Line for vials with lyophilization downstream







Veterinary pharmaceuticals – vaccines for fowl

Modern stockbreeding prefers live vaccines to protect fowl. Production of veterinary vaccines follows principles that are quite similar to human medicine. Optima Group Pharma realized a filling project for a large German veterinary medical manufacturer.

It was the second line Optima installed for this customer and commissioned the machine in spring 2010. Highly satisfied with the first system, the customer had decided to order a second machine of the same type – this time in customized design as an integrated unit for an already existing processing system: The vials are filled with the live vaccine and then fed into the freeze drying process by an auto-matic loading unit.

Automated filling quantity control

Ready to be sterilized, the vials arrive at the first processing station, a sterilizing tunnel with a combination of laminar flow and infra-red light technologies. Discharged from the tunnel, an infeed rotary disk receives the containers and transfers them into a transport rake for one-lane processing. Two-lane processing starts with tare weight control for the
glass containers. In a next step, the rotary pumps of the servo-controlled module dose the live vaccine. The subsequent
gross weight control is also carried out in two-lane operation. The in-processcontrol guarantees a 100% check of all
containers. The weighing results are additionally fed into the tendency control which uses the data for continuously optimizing dosing precision. In the next step, a vacuum gripper picks the lyophilization stoppers from their infeed and presses them onto the vials - just deep enough to leave the dent in the plug open to allow the liquid to freely escape during the ensuing freeze drying process. Stoppers are fed in through a bunker with a connected sorter bowl to ensure correct alignment. An optical sensor checks the protruding height of the plugs after pressing-in before the containers arrive at the active product discharge or, if a reject, the product reject discharge. A fully automated frame loading unit by Optima Group Pharma approaches and loads the customer’s lyophilization system: For this step, the distance between the filling machine and the loading unit is bridged by a transport belt. The automatic loading unit receives the vials in rows and – after formatting – loads them into the loading frames. Frames replenished with vials are pushed into the freeze dryer. After the lyophilization process, the vials receive their definite closure (in the pharmaceutical sense) in the form of a crimp cap. To optimize co-ordination of the freeze dryer with the filling and packaging processes, the controls of the lyophilization system, the loading system, and the upstream Inova machine are interconnected. The general capacity of the GMP-certified line is limited due to the long freeze drying periods: Each batch requires approx. four to five days! The presently processed format - 20R - is processed and closed in batches with 5,000 containers – which does not even come close to the line’s performance maximum. It is an essential feature of the line, which is flexible with regard to capacity and design, that it can always be upgraded for loading a second lyophilization system. Moreover, other formats can also be processed without difficulty: The line has the capacity to fill and close vials from 2R to 100H.

100% tailored to customer requirements

The line comes with the same functional scope as the system that has already been implemented, but was tailored to the client’s production environment. Optima invested great care into optimum space use, which yielded a highly compact design. Optima Group Pharma implemented all aspects of the co-ordination and integration of the control technology if the loading unit with the lyophilization system came from an external supplier. If another freeze drying system is added, as intended by the customer, transport paths and the entire line architecture are already in place.


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