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Pharma and Biotech
Pharma and Biotech
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Do you have highly potent, very expensive or extremely difficult to fill medical products? The contract filler, Swissfillon (now ten23 health), was founded just for you. The Swiss based company covers laboratory requirements up to commercial small batch sizes. The heart of the equipment is a MultiUse filler from Optima Pharma.
Fast and at the same time a high regard for all details and unique machine technology: the business plan of Swissfillon (now ten23 health) was very demanding. “Our target was 4 years from the concept to the first customer fill”, reports Daniel Kehl. Many people doubted if this and other objectives could be met, but we were able to set-up a contract filling operation with a lean team and run it efficiently.
Daniel Kehl is the founder of the young start-up company Swissfillon (now ten23 health) and a veteran of the pharmaceutical engineering industry. For years, he was responsible for the design and manufacturing process for a well-known Swiss pharmaceutical company at various international locations, and then he founded the consulting firm Pixon that today employs over forty people in Switzerland and Germany. Since 2013, Daniel, a Process Engineer is solely concentrating on the exciting undertaking at “Swissfillon” (now ten23 health).
Swissfillon (now ten23 health) has been on the market since the fall of 2017 and fills highly viscose and highly potent pharmaceutical products for customers and employs twelve people. To date the company has received fifty inquiries without actively advertising their service capabilities.
However, let’s look back to the beginning: at the time of the company’s founding there was no machine on the market that was able to fulfill all of the requirements. Three suppliers were potential vendors that wanted to understand the very detailed specifications jointly created with Pixon within the given timeframe and cost structure. During this time, Optima was in the design phase of the MultiUse filler. This concept should prove to be an ideal solution for Swissfillon (now ten23 health).
Swissfillon (now ten23 health) focused on the market niche for extremely challenging and complex to process pharmaceuticals. Daniel Kehl explained it was based on some inquiries: “One evaporated drop of a highly potent cancer medication can be extremely harmful for the machine operators.” Very expensive products are another consideration that the machine builder has to think about: “The fill accuracy has to be extremely precise, if one milliliter of product costs 10,000 Swiss Francs,” says the founder from the Valais region.
Finally, physical characteristics like the viscosity of the products such as oil based pharmaceuticals that have to be administered subcutaneously or gel like bone formation compounds are other examples why Swissfillon (now ten23 health) is the best solution for complex to process products.
The development and commercialization of these pharmaceuticals often demand product specific fill tests. Sometimes the interaction with Optima Pharma’s technology center was utilized, where for example, product specific filling needle designs or parameters for the pump filling system for Swissfillon (now ten23 health) were determined. Swissfillon (now ten23 health) envisions itself as a contract and development partner and service provider for customers with products in the clinical phase or customers that are ready to launch their product onto the market.
Not only for very small batches, but also for commercial sized batches for small volume products (up to 100 liter) relating to special therapies or rare diseases can be filled with this machine design. According to the expert opinion, it is not profitable for most pharmaceutical companies to invest in this very specialized area in their own machinery since they would not be used to asset capacity.
One of the many questions is how a contract filler in an expensive region like Switzerland, in Visp, surrounded by the highest mountains of the country, can exist logistically and economically. The pharmaceutical specialist explains this is done by incorporating a high degree of automation. The pharmaceutical logistics, on the other hand, is comparable to any other manufacturing site’s location concerns in the perspective of effort and cost. Previous customers are not just from Switzerland, but other countries within as well as outside of Europe. Another special attribute of Swissfillon (now ten23 health) is that filling can begin within one to two months from the receipt of an order.
The visitors realize how fast, energetic and passionate Daniel Kehl is about his work. He also reports that it was a rocky road to get the machine that they needed. He believes that never has there been so many functions combined into such a compact, flexible and highly automated machine.
All the more, he is convinced of the results. In order to achieve a high machine availability, a complete format change had to be accomplished during one shift, including format changeover work, isolator cycle and the adjustment of the new disposable product path. Mission accomplished - today it is achievable without any time constraints in one shift. Concerning the disposable product path: Daniel Kehl reports that all parties were involved in the development of the machine. Today Swissfillon (now ten23 health) guarantees that no product contact parts get in touch with other products during the handling process. Each product receives its specific product path.
Many additional machine features of the OPTIMA MultiUse filler were requirements for Swissfillon’s (now ten23 health) success. Especially the high degree of automation and subsequently fewer personnel needed to operate the line. After an initial semi-automatic debagging /unpacking station, the filling process is fully automated - and highly flexible at the same time. The pre-sterilized containers, ready-to-use syringes, vials and cartridges (nested) are taken out of the tray or tub, fed into the production process, transported through the machine and processed. Robotic technology and a completely new designed multi transport system supplements the machine. Vial formats from 2 to 30 ml or syringes from 0.5 to 5 ml and 3 ml cartridge formats can be processed on the MultiUse filler.
Several functions of the MultiUse filler pay off when an expensive product is processed in order to minimize product loss. During the start-up mode, containers are filled on a weighing cell. The benefit: already during the priming process saleable product is being produced (no product waste). The same function is offered during the empty-running mode at the end of the batch - there is only one container to reject that was not completely filled. Various process controls recognize the missing product or missing stoppers and crimp caps during the handling of the batch. The re-dosing, re-stoppering and re-capping features incorporated into the multiuse system pauses the system, implements a corrective action automatically and then returns to processing mode. In applications utilizing a printer, if a coding issue arises, a reprint is possible at the end of the batch and is inspected by a camera system.
“The fill accuracy of Optima is unmatched”, says Daniel Kehl. Another important criterion for a maximum product yield for expensive pharmaceuticals. The peristaltic pump system is an in-house design of Optima. Up to 1,800 containers per hour can be processed. The MultiUse can be equipped with additional filling systems, if required. This is a great benefit for Swissfillon (now ten23 health) to process different products with different characteristics with different pump system.
The safety features of the MultiUse filler are indispensable for Swissfillon (now ten23 health). “Like an airplane - nothing can go wrong at any time”, explains Daniel Kehl. The machine’s design reflects these multiple times. A double-paned isolator is installed in the front part of the machine, where no product is handled. Starting with the filling machine, only specific single-pane isolators are installed. Double-panes are omitted at this point of the machine since toxic substances might not be completely washed out. The single-pane isolator provides return air ducts. Back-out filters are located at the end of the air ducts. These double filters can be taken out without direct contact and without opening them. During the removal, a bag system ensures that no product ingredients escape. Subsequently, the ducts are rinsed with water. In addition, the machine has a hand spraying system to remove toxic ingredients. Only after a complete wash-down and drying of the machine can the machine be opened.
Isolators from Metall+Plastic stand out by their extremely low leak rate. To ensure the safety of the surrounding area, the clean room design ensures under-pressure in the filling area instead of the otherwise common over-pressure. This ensures that no product ingredients enter the machine surroundings.
The isolators are additionally prepared for cold filling and are equipped with a temperature control. HVAC-units prevent condensation build-up. After the closing process, the containers are cleaned and dried from the outside to prevent any toxic products from sticking to them. Several process controls inspect and ensure this function. Daniel Kehl: “If only one drop is missing, we will detect it.”
Daniel is especially proud of one worldwide new innovation: the MultiUse filler from Swissfillon (now ten23 health) fills cartridges without any bubbles. This feature is very important since the cartridges are inserted into auto-injectors or pens and are mostly administered in small dosages. Only by using bubble-free filling can incorrect dosage by the user be avoided. This feature is also interesting for oxygen sensible pharmaceuticals. Together with the container manufacturer Ompi, who was involved from the start of Swissfillon, all involved parties invested a lot of development work.
“By means of a sophisticated filling and closing process, Optima went to the physically feasible limits,” Kehl is convinced. Vials and ready-to-use syringes are filled by filling weight and not volumetrically.
Finally, an additional aspect that is very important to Swissfillon. Clean room space is expensive. Therefore, Optima optimized the dimensions of the MultiUse filler and arranged the machine in a U-form.
According to the opinion of Daniel Kehl, Swissfillon is one the most flexible and agile CMOs worldwide. Certainly, the company is perfectly prepared for current and future responsibilities. A unique machine, a small but highly qualified team in an exceptional location that draws specialists from around the world.
Optima is unsurpassed when it comes to filling accuracy.
