One vial, one filling material, one closure – done. But it is not always that simple. In fact, when diagnostic products from bioMérieux are filled, there are four very different media. In 2016, Optima Pharma has developed a specific production line for this. Because of the principle of "never changing a running system", the company has now decided to purchase a duplicate of this system for its Chinese production site in Suzhou. Operators there are able to familiarize themselves with the process in advance, using a laboratory pilot line from Optima Pharma to run the approval process.
Suzhou, with its many canals, is known as the Venice of the East. The city, with its numerous gardens and temples, attracts not just a large number of tourists. Numerous international companies such as Apple, Bosch and GlaxoSmithKline have settled in this booming metropolis situated about 100 km west of Shanghai. bioMérieux is a global leader in in-vitro diagnostics and also operates one of a total of six Chinese subsidiaries there. As part of new production facilities, a vial filling line for one of the manufacturer's best-selling products is to be built there. bioMérieux is already producing the diagnostic product in the USA using a special, complex process line that was set up by Optima over five years ago.
The great market success of the product made it vital to increase capacity, and at the same time to conquer the Asian market. Firstly, the U.S.-based project team and the company's French headquarter thoroughly reviewed the options with a variety of line types from different manufacturers before making a decision: They came to the conclusion, to replicate the technical solution used in the previous successful project is the best option. In addition, the decision was taken to set up a semi-automatic laboratory line that would accurately map the process. Alain Gourmelon, Senior Vice President Global Manufacturing Support & Industrialization at bioMérieux, explains what the aim was: "By doing this, we want to develop the relevant expertise at our Chinese site ahead of time. The employees there can acquaint themselves with the technology they need right away. This will ensure the smooth ramp-up of the production line." In addition, the pilot line will support the product approval process for China ahead of time so that the filling line can go directly into production as soon as it is delivered.
It is worth taking a look at the USA to understand the process. This is where the big brother of the future Chinese line is already located, with twice the capacity. In the USA, the different dosing and filling modules, as well as the capping machine, have a double design. There, the two lines intersect at a furnace where the partly filled vials are heated. At Suzhou, all of this is only needed once.
The line includes several filling stations for every different media that are not easy to handle. This is due to the high complexity of bioMérieux's product.
Almost a 100 % technology transfer – bioMérieux is extremely consistent in this respect. "Sharing experiences and practices worldwide is part of bioMérieux’ s DNA as a way to learn and grow together. So we prefer to rely on the well-established technology of our proven solution." says Will Darrigrand, VP Engineering Americas at bioMérieux. This makes it easier for the U.S. team, who are familiar with the line, to provide future support for the Chinese team.
The Project Engineering Managers, Claudio Schneider and Mark Seitz, who were entrusted with project planning for the new line in early 2019 at Optima Pharma, were able to build on existing technology. "The line includes several filling stations for very different media that are not easy to handle. This is due to the high complexity of bioMérieux’ s product," explains Schneider. Different filling techniques for very different media and quantities have to be combined. Additionally, there is a great difference in the requirements for filling accuracy.
The line includes three dosing modules. After determining the exact tare, the vials reach the first station; here their inner walls are sprayed with the first medium by a micro-dosing device. Without any further intermediate weighing, the next station delivers a second liquid. After controlled weighing, the bottles pass through a tunnel oven where the added components are dried. This is followed by the second filling machine. Here a resin-like medium is introduced after a further weight check. Schneider explains that this stage, which is performed with the aid of an auger doser, as being particularly difficult: "The dosage of that component is highly dependent on its moisture content. In this respect, the experience gained in designing the U.S. line has been of great help." After the correct dosage has been checked by the next in-process control load cell, twelve vials are simultaneously filled with another liquid medium. Finally, they are closed with a stopper and fitted with a cap, which is subsequently crimped.
This technology is also used in the laboratory pilot line, although a variety of steps are carried out by hand. It had already been delivered and is ready to run, around few months before the production line. A few thousand vials will probably have been produced by then, which will be used, among other things, for team training and local know-how development.
In each case, the technical platform for dosing the key components is the OPTIMA VFVM filling machine, where a rake ensures the safe transport of bottles. There is a total of five in-process control points that ensure quality by verifying correct filling with the individual components of the diagnostic product. At the end of the line, there is the OPTIMA VVM2428 closing machine, which also carefully transports the products.
The line is to be delivered to China in a couple of months. It is anticipated that set-up and start-up will run smoothly. Both the manufacturer and the users will be able to draw on the tried-and-tested processes of the preceding system, so technology transfer pays off. "In this way we will benefit once again from Optima's experience and the reliability of its technology," expects Foster Zhang, Senior Director of Manufacturing at bioMérieux China.