Everything is easier, though, when the chemistry is right in both the literal and figurative sense.
A classic example is when Syntegon subsidiary Pharmatec and Vetter worked together to install a new purified water (PW) generator as part of a site expansion in Langenargen, Germany.
The successful collaboration also laid the foundation for an extended partnership between the two companies.
With more than 75 years of experience, 7000-plus employees worldwide and sites in Europe, Asia, and the US, Vetter Pharma-Fertigung GmbH & Co KG is a leading global contract development and manufacturing organisation (CDMO) for injectable APIs.
Vetter supports pharmaceutical companies with comprehensive fill-finish services along the entire value chain. Its range of services extends from clinical development, aseptic filling and visual inspection to the assembly of complex injection systems.
Secondary packaging, analytical quality control and support with regulatory issues are also part of Vetter’s offerings.
Laying the foundation for growth
The company's services are popular: Vetter is experiencing long-term growth and a steady increase in demand. To meet this need, the company has been investing in the expansion of its portfolio and sites for years.
One of these is Langenargen in Germany, where Vetter has been filling liquid and lyophilised products into vials and syringes since 1998.
The facility currently has four filling lines with two more to be added in the future. This requires meeting certain conditions: providing a sufficient supply of pure media — such as water or steam to feed and clean the lines — is essential.
Until recently, two generators with a total volume of 15,000 L/h produced purified water (PW) by reverse osmosis in Langenargen.
Whenever the larger of the two units was out of operation for sanitisation purposes, the smaller one was no longer able to meet the demand for PW.
To secure production capacity and prepare for an increase in the future, Vetter needed another PW generator.
Pure media in pharmaceutical production
Purified water plays a central role in the pharmaceutical industry – both to clean production systems, format parts or containers and as a basis to produce other water quality levels (such as highly purified water [HPW] and water-for-injection [WFI]).
The purified steam (PS) required for sterilisation is also produced from PW.
Quality requirements for these pure media are strictly regulated by the European Pharmacopoeia (Ph. Eur.) and/or the US Pharmacopoeia (USP).
Vetter even goes one step further and sets its own, significantly stricter limits regarding the microbial count in PW to ensure maximum patient and product protection.
This was also one of the specifications for the project in Langenargen: Vetter was looking for a solution that could produce PW at WFI quality.
A rigorous selection process
Dietmar Waizmann, Head of System and Service Media in Langenargen, has been with Vetter for more than 30 years. He was well aware of the requirements for PW production at the site and began a careful selection process.
“We drew up a very comprehensive specification sheet,” Waizmann explains. “This served as the basis for us to take a close look at the offers from various manufacturers and compare them with our needs.”
The PW generator from Pharmatec impressed from a technical standpoint with its capacity control, which automatically adapts to the requirements of the storage tanks and ensures rapid availability even if the containers are temporarily emptied.
Despite its price advantage, the unit has a longer amortisation period compared with competing ones, mainly because of its lower yield.
Moreover, Dietmar Waizmann’s team had not yet worked with Pharmatec as a project partner before. However, they were able to convince Vetter that the system is more stable and reliable than others in the long-term … if it’s not pushed to its limits.
After the first meeting, Waizmann was already convinced that he had found the right partner in Pharmatec.
The decisive factors were not only the likeable manner and technical proficiency of the experts, but also their flexibility and willingness to respond individually to the special conditions on site – particularly regarding space constraints.
Made to measure
Nick Eilenberger, Engineer Process Design and Project Manager at Pharmatec, recalls: “The available floor space was too small. But, when necessary, we are happy to deviate from the standard.”
During an on-site visit, the available space and the existing connection options were measured precisely and a custom-made unit was designed.
The project team faced yet another space problem during installation: owing to the construction of a new production facility opposite, space for the delivery and installation of the new unit was limited.
“We simply planned the frame in two parts, delivered it as such and assembled it on site during installation,” Eilenberger explains.
The PW generator, which Vetter uses to feed the distillation systems for WFI processing and to clean format parts and syringe bodies before autoclaving, has a capacity of 10,000 L/h and includes several process stages.
First, the potable water is softened in an ion exchanger. Reverse osmosis is used to reduce the ion content of the softened water and retain the majority of any germs and endotoxins.
The carbon dioxide content is then reduced by membrane degassing, followed by electrodeionisation and ultrafiltration to remove residual ions, germs and endotoxins. The entire system can be sanitised with hot water.
A partnership built to last
Once installed, commissioning and qualification of the new system went smoothly. “This was not the only time we received excellent support from Pharmatec,” reports Dietmar Waizmann.
“I was impressed by their availability, flexibility and productive and friendly co-operation. The chemistry was just right.”
The successful project in Langenargen laid the foundation for further collaboration between Vetter and Pharmatec.
Two more PW generators and softeners have already been installed at the Vetter site in Ravensburg, and two further PW generators with integrated softening in Rankweil, Austria.
Dietmar Waizmann is convinced: “Pharmatec is the right partner for us to continue on our growth journey and shape the pharmaceutical industry of the future together.”
