It all depends on the right filling system

Da die Peristaltikpumpe mit Ausnahme der Schläuche keine Formatteile benötigt, lässt sie sich mit einer Hand bedienen. / The peristaltic pump can be operated single-handedly, as it does not require any format parts.

Die einfache und äußerst flexible Drehschieberkolbenpump sorgt mit ihrem volumetrischem Funktionsprinzip für hohe Dosiergenauigkeit. / The easy-to-use, highly flexible rotary valve piston pump with its volumetric operating principle ensures high dosing accuracy.

Die Rollmembranpumpe wurde bislang vorrangig in Nordamerika für die Abfüllung kostenintensiver Produkte aus dem Biotech-Bereich angewendet. / To date, the rolling diaphragm pump has primarily been used in North America for filling cost-intensive biotech products.

Die platzsparende Bauweise mit einfachen Formatwechseln des Zeit-Druck-Füllsystems ermöglicht eine präzise und produktschonende Abfüllung. / The time-pressure filling system enables precise and gentle filling thanks to its space-saving design and simple format changes.

Dank hochentwickelter Sensorik kann das Masse-Durchfluss-System Heiß- und Kaltabfüllungen bewältigen. / Highly developed sensor technology allows the mass flow system to handle hot and cold filling.

Kombifüllstationen bieten höchste Flexibilität und machen Produktionslinien jederzeit anpassbar. / Combi filling stations offer maximum flexibility and make production lines adaptable at any time.

Neue digitale Lösungen tragen zu höchster Präzision und Transparenz im Abfüllprozess bei und eröffnen neue Möglichkeiten für die vorausschauende Wartung. / New digital solutions boost precision and transparency in the filling process, opening new possibilities for predictive maintenance.

In den unternehmenseigenen Laboren führen die Expertinnen und Experten von Syntegon umfangreiche Versuche mit dem realen Produkt durch. / Syntegon's experts carry out extensive tests with the real product in the company's own laboratories.

From highly potent to viscous and liquid drugs, pharmaceutical producers and contract manufacturers must fill numerous medicines and suspensions into a wide variety of containers. Choosing the right filling system is crucial for efficient and safe processes. This requires a partner with a broad portfolio who is capable of accurately adapting filling systems to the respective products.

The range of marketed pharmaceuticals is greater than ever before. On the one hand, demand for blockbusters and generics remains unchanged. Pharmaceuticals such as blood thinners, painkillers and insulin have become a mainstay in pharmacies. New developments such as the incretin mimetic semaglutide, which has become very popular in obesity and diabetes treatment in recent years, are significantly expanding the number of available drugs.

On the other hand, the rise of advanced therapy medicinal products (ATMPs) such as cell and gene therapies as well as biotechnologically processed tissue products underpins the industry’s continued diversification. Highly individualized therapeutic options pose new challenges for the filling of small and very small batches. But which filling system is the right one for which product?

Peristaltic pump: particularly suitable for single-use applications

The peristaltic pump is a well-established and widely used technology on the market. As it does not require any format parts apart from the tubes, it can be operated single-handedly. Its ease of use, gentle product handling, and precise dosing make the pump an ideal choice for shear-sensitive products and filling operations in barrier systems according to EU GMP Annex 1. The peristaltic pump can be permanently installed or applied as single-use system, since the tube and needle can be inserted and replaced very easily. In addition, the peristaltic pump achieves maximum product yields, hence meeting an essential requirement for the filling of high-priced biopharmaceuticals and very small quantities.

Rotary valve piston pump: simple, cost-effective, and robust

The extremely flexible rotary valve piston pump is even more widespread than the peristaltic pump. As a simple, cost-effective, and robust filling technology, pharmaceutical manufacturing companies often use them for several applications. The volumetric operating principle ensures high dosing accuracy. In contrast to the peristaltic pump, the rotary valve piston pump can also process aqueous and highly viscous liquids such as Botox or hyaluronic acid. In addition to the stainless-steel version, the pump is available as a ceramic version for extreme temperature ranges, allowing to gently fill hot and abrasive products.

Rolling diaphragm pump: from the U.S. to Europe

The rolling diaphragm pump perfectly lends itself to the filling of sensitive biopharmaceuticals. It combines the advantages of the peristaltic and rotary valve piston pump: the absence of shear contours enables gentle product handling, while the volumetric filling system ensures precise dosing. The innovative concept uses a flexible diaphragm to transfer the product gently through the piston and the pump body. To date, this technology has primarily been used in North America to fill cost-intensive biotech products. It is now also available in Europe in various sizes for between two and 250 milliliters. In addition to the CIP/SIP and stainless-steel versions, the single-use option offers major advantages.

Time-pressure filling system: compact with few moving parts

Pharmaceutical manufacturers who require high output and a large number of filling stations including barrier systems can rely on the time-pressure filling system – especially for high volumes of insulin or new semaglutide products in cartridges. The space-saving design of the filling system ensures good accessibility and easy format changes. It enables precise and gentle product filling, not least due to a reduced number of moving mechanical parts. The control algorithms keep product loss low and are as intelligent as the mechanics are simple. Although the time-pressure filling system is not recommended for viscous products, it reliably processes shear-sensitive drugs.

Mass-flow system for hot and cold filling

The mass-flow system operates in a similar way. It uses the same components as the time-pressure filling system and offers a viable solution for special applications such as highly potent cytostatics. With one major difference: the filling process is controlled by a flow meter instead of time pressure. A mass flow sensor operating according to the Coriolis principle in each filling line ensures immediate 100% in-process control (IPC) and precise filling processes. Thanks to this highly developed sensor technology, the system can handle demanding applications such as hot and cold filling and is the preferred choice for X-ray products.

Combi filling: several filling stations on one machine

Growing numbers of pharmaceutical liquids and increasingly frequent product changes pose new challenges to pharmaceutical producers and contract manufacturers alike. How can different products with different properties be filled efficiently and in a space-saving manner? The answer is combi filling stations: thanks to the combination of several filling systems on one machine, they ensure maximum flexibility and allow to adapt production line set-ups at any time. Depending on the design, the solutions can accommodate up to four common filling systems, which can be used in the stainless-steel version and for single-use systems that process different containers.

Smart Pump: making filling systems intelligent

As with all production processes, transparency is becoming increasingly important during filling. Latest developments and additional functionalities ensure that pump-specific parameters such as cleaning status, serial numbers, and correction values are transmitted to the filling machine using a reader and state-of-the-art RFID technology. Operators can read the visualized data on the machine’s HMI conveniently and reliably. This way, new digital solutions contribute to maximum precision and transparency in the filling process, opening new possibilities for predictive maintenance.

Functionalities for maximum product yield

Other functionalities relate to increasingly expensive, specialized medicines such as blood plasma derivatives. Manufacturers of those products focus on high product yields. Micro-dosing, for example, allows containers to be weighed and filled very precisely during start-up and shutdown. In high-performance machines, the last five percent of the product can be dosed even more precisely and within narrower tolerance limits using a very small filling needle. This allows manufacturers to achieve maximum filling accuracy even during fast filling processes. Moreover, product losses can be prevented: if a container is underfilled, the process is stopped briefly, and the filling station moves back to the filling point. This way, no container is rejected due to inaccurate filling volumes.

Support for the right choice

Given the wide range of possibilities, the most pressing question remains which filling system to use for a particular product. This is where system solution suppliers such as Syntegon can provide support with comprehensive service and sound technological and pharmaceutical expertise. Syntegon’s laboratories offer pharmaceutical companies extensive trial options with their real products. Services include the specific testing of selected filling systems, the siliconization of products and stopper tests for syringes, as well as the comparative testing of different filling systems.

In case of portfolio expansions, for example for new medicines or modified output quantities, the best retrofitting or converting options for filling systems can be identified and implemented. Possible changes include switching from stainless steel to ceramic or to a combi filling station with a single-use filling system including a pump trolley. In addition, there is a wide variety of format sets as well as a comprehensive range of accessories for the various filling systems available to retrofit an existing system. Syntegon's experts work closely with customers to find solutions for all product characteristics. Because one thing is certain: choosing the right filling system is crucial for efficient liquid pharmaceutical filling.