High Capacity Sterile Filling Line Is a Masterpiece of Sophistication

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Working to the millimeter

The high capacity machine fills 36,000 vials per hour and covers a correspondingly large area; precision clad in glass and stainless steel, it extends across 400 square meters, occupying an area as large as four houses. Later on at the customer’s premises, the line will be accommodated in three rooms. The line incorporates seven modules: an upwrapping and loading station, cleaning machine, sterilization tunnel, filling & closing machine, crimp-cap machine, coding and inspection machine and two magazining devices. All the individual components, from the stainless steel filling needle through to the stainless steel washing machine guard, began life as metal parts in the productions halls at the Ilshofen plant.

“We work with an extremely high degree of vertical integration,” emphasizes Reber. So that all the components come together like ballet dancers in a perfectly choreographed performance later on, precision work is called for throughout the entire line — but nowhere is this more evident than in the customization of the isolator, which in this case comes from Skan. The moment of truth is when the engineers marry up the isolator with the filling machine — when they find out whether the tailor-made suit fits or not.

Another feat of precision tailoring are the glove ports. In order to ensure that the ports are correctly positioned and access to the filling space is possible, a mock-up was constructed and tested thoroughly over several days. The cycle for hydrogen peroxide decontamination developed by Skan for the customer is likewise finely tuned. That is another special aspect of this project, says Wieland: “Normally, the customer does it themselves.”

A further challenge was the sensitivity of the product dispensed, which reacts to hydrogen peroxide and therefore requires a residual concentration of 0.003 ppm of hydrogen peroxide. To permit as much flexibility as possible, the isolator is fitted with a quick airlock which allows non-autoclavable materials to be introduced and taken out without impairing sterility during the filling process as well.

The twelve-position filling & closing machine has two dosing stations. Therefore, the customer has the choice of applying the best dosing process for different substances in each case. The time/pressure dosing process is particularly gentle on therapeutic proteins with long molecular chains. If, on the other hand, high metering accuracy is preferred, valveless rotary piston pumps are used. The time/pressure dosing system is installed in duplicate, saving time on product changeovers.

While production operations are running with time/pressure dosing system no. 1, the no. 2 system can be cleaned, sterilized and prepared for subsequent productions runs, which means that the production line is efficiently utilized even when processing small and varied batches. What is more, while operators have the option of filling four different vial sizes – 3, 5, 10 and 20 ml — there is just one object holder which saves considerable time on format changes.

* The author is an editor of PROCESS.

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