Modern stock-breeding prefers live vaccines to protect fowl. Production of veterinary vaccines follows principles, which are very similar to human medicine. OPTIMA GROUP Pharma has realised a filling project for a large German veterinary medical manufacturer.
It was the second line OPTIMA has installed for this particular customer. The first machine was commissioned in spring 2010. Highly satisfied with the first system, the customer decided to order a second machine of the same type, this time 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 automatic loading unit.
Automated filling quantity control
Ready to be sterilised, the vials arrive at the first processing station, a sterilising 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 a two-lane operation. The in-process control guarantees a 100% check of all containers. The weighing results are additionally fed into the tendency control, which uses the data for continuously optimising dosing precision.
In a next step, a vacuum gripper picks the lyophilisation 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 the product reject discharge.
A fully automated frame loading unit by OPTIMA GROUP Pharma approaches and loads the customer’s lyophilisation 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 lyophilisation process, the vials receive their definite closure (in the pharmaceutical sense) in the form of a crimp cap. To optimise coordination of the freeze dryer with the filling and packaging processes, the controls of the lyophilisation 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 approximately 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 lyophilisation system. Moreover, other formats can also be processed without difficulty as 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 has implemented all aspects of the coordination and integration of the control technology if the loading unit with the lyophilisation 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.