Two 12,000-liter tanks take contract production to a new level

With the acquisition of two large tanks, each with a capacity of 12,000 liters, Hänseler Swiss Pharma is taking its customized contract manufacturing to a new level - even for complex manufacturing processes with flammable liquids under inert conditions.

In the subsequent discussion, Project Manager and Development Engineer Karl Geisser and Head of Production Dr. Dominique Schreiber provide insights into the production and use of the new acquisitions.

Hänseler Swiss Pharma is taking a decisive step towards the future: with the purchase of two state-of-the-art 12,000-liter tanks, the Herisau-based company has significantly expanded its ability to efficiently contract manufacture - at least compared to the previous maximum batch size of 2,000 liters. "These tanks are a game changer in pharmaceutical production at the site. They enable us to handle large-volume orders," explains Dr. Dominik Hauser, CEO of Hänseler Swiss Pharma.

With an impressive total capacity of 24,000 liters, Hänseler is setting new standards in contract manufacturing. Production takes place under GMP quality standards: every step in the entire value chain is checked, from the raw material supplier to the raw material itself, right through to in-house refinement.

The commissioning of the new tanks goes hand in hand with the new building in Herisau. The new building doubles the previous production capacity. This creates space for the acquisition of process systems. For example, a state-of-the-art filling and packaging line for liquids, including serialization of finished medicinal products. In this context, Hänseler Swiss Pharma sees the tanks as a symbol of excellence and technological progress in Switzerland as a pharmaceutical location.
 

Thought bigger, but no less flexible

Despite the size of the tanks, the new acquisitions with variable batch sizes from 3,000 to 12,000 liters offer flexibility for tailor-made solutions. If smaller quantities are required, smaller tanks come into play again, where a batch of 0.5 liters or more is possible. The production of mixtures in the form of active ingredients and medicines is possible from both liquid and solid raw materials.

After production, Hänseler Swiss Pharma offers containers with a capacity of 10 ml to 1,000 liters and can thus meet various customer requirements. Filling is carried out manually, semi-automatically or fully automatically in customer-specific containers and outer packaging, depending on the size of the order and urgency.
 

Also designed for sensitive productions

Trading raw materials and refining them into active ingredients is not only the origin of Hänseler Swiss Pharma, but also the core competence of the Swiss company - even in large-scale production. With proud access to over 3,000 raw materials, there are also many possibilities in contract manufacturing in the new tanks from small to medium batch sizes. The tanks can be used to produce aqueous and ethanolic solutions as well as numerous tinctures. "The tanks are very versatile, both for the production of herbal medicines, one of our core competencies, as well as for new developments and process transfers for our industrial customer projects," adds Dr. Dominique Schreiber, Head of Production at Hänseler Swiss Pharma. Once production is complete, the fully automated, validated cleaning process enables a quick, efficient changeover from one product to another without the risk of contamination.
 

Tinctures in large quantities

Die Einführung der 12'000-Liter-Tanks bei der Hänseler Swiss Pharma ist ein Meilenstein für das Unternehmen als pharmazeutischer Lohnhersteller. «Die beiden 12'000-Liter-Tanks sind als Teil der gross angelegten Kapazitätserweiterung von Hänseler Swiss Pharma zu verstehen» so Dr. Schreiber. Die Produktion pharmazeutischer Produkte in Grosstanks zeigt, dass Quantität nicht mit dem Verlust von Qualität einhergeht. Auch feinste Kamillen- oder Opiumtinkturen kann Hänseler Swiss Pharma heute in industriellen Mengen unter GMP/GDP Bedingungen herstellen und ausliefern.

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In conversation

with project manager and development engineer Karl Geisser and head of production Dr. Dominique Schreiber.
 

Karl Geisser, as project manager and development engineer, you played a leading role in tank procurement. What were the reasons for this new acquisition?

Geisser: The process was triggered by the desire for significantly larger batch sizes with the various advantages of simpler goods receipt and the customer being confronted with fewer batch changes in the production process. Initially, only one tank was planned. During the design phase, another tank with the same volume was added to the system in order to be able to filter large quantities.

In the production of natural extracts - the core business of Hänseler Swiss Pharma - this filtration is a necessary process that is only possible by transferring the product to a second tank with the same capacity.

Synergies were recognized and technically implemented in the project: Two products can be manufactured at the same time, as the two tanks are completely separate from each other.

How do you approach a project like this? How do you build a 12,000 liter tank?

Geisser: Everything starts with an idea and initial discussions. Once the idea has been finalized, the order is handed over to the development team and myself. The first step is then to outline the process landscape: What do we already have? Where do we want to go? Where do we set ourselves limits? In this particular case, we then approached potential manufacturers and clarified what their approaches would look like. After initial price clarification, we then decided on the most suitable supplier and started the detailed design phase in order to be able to provide the manufacturer with precise specifications. The project teams are put together according to the requirements of the project phases so that the best possible expertise can be brought in. Discussions and clarifications on risk, safety, process and GMP suitability follow. Initial implementation feedback is reviewed. In the subsequent implementation phase, the tanks become visible for the first time, followed by commissioning.

Finally, the system must be officially approved. The system and the safety systems are then put through their paces as part of the qualification process. The cleaning validation concludes the complex test procedure. The system has been approved by Swissmedic and is ready for production.

From internal approval to first production: how much time is there in between?

Geisser: The tanks were set up and repaired within around 20 months. That's a good time and shows that the implementation of such special projects can be relatively agile.

With a capacity of over 10,000 liters per tank, the new mixing devices massively increase the production volume of Hänseler Swiss Pharma. How do customers benefit from this new acquisition?

Schreiber: Customers benefit in two ways: Firstly, we are more open to requests that go beyond the previously defined batch sizes of 1000 to 2000 liters and now offer batch sizes of up to 2x 12,000 liters. This allows us to respond even more flexibly to customer requests. Secondly, we can now produce large quantities of orders that we previously produced individually and in smaller quantities. This is an advantage in terms of time and ultimately also more cost-effective for customers.

The tanks are set up, the supply lines are installed and connected and the agitator is ready. Which customers are particularly interested in production in the large tanks?

Schreiber: The tanks are the logical extension of our previous core competencies in the production of herbal medicinal products. Production in the tanks is particularly lucrative for industrial customers who would like to purchase liquid products from us, as they have larger sales volumes from the outset. Thanks to the new tanks, we can now offer such large orders more flexibly in terms of feasibility, production time and costs.

The mixing tanks can mix liquid-liquid and liquid-solid. Where do the giant tanks reach their production limits?

Schreiber: The tanks are very versatile. They are particularly suitable for the production of aqueous and ethanolic solutions such as various tinctures and extracts. Solid-liquid products are also possible, but powder mixtures must first be dissolved in smaller tanks before being added to the large tank, as the large tanks do not currently have a solids feed. However, a concept for a possible retrofit has already been drawn up.

Geisser: No honey-like liquids - i.e. liquids with a high viscosity - can currently be mixed in the tanks. If there is a need for this in the future, it would have to and could be examined.

Production can take place in the tanks under inert conditions. How does this process work in the large tanks and why is it so important?

Geisser: The inertization process is the same as in smaller tanks. The oxygen in the tanks is mixed with nitrogen by pumping it up several times. Subsequent degassing minimizes the oxygen content in the tanks so that the product cannot oxidize. This process is automated and takes around 15 minutes per cycle.

Schreiber: Inertization is important for safety reasons on the one hand, and on the other it prevents oxidation reactions from occurring in the product, resulting in a loss of quality.

A look into the building next door: Swissmedic is due to approve Hänseler's new M building in 2025. What is the connection between the 12,000-liter tanks and this construction project?

Geisser: The tanks were installed with foresight so that they can be connected to the new building without any problems.
 

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