The demand for systems that can only be used to fill small batches, but which can be converted very quickly to other medicines or other packaging materials, is growing rapidly. This is a trend that manufacturers of filling and packaging machines are increasingly having to adapt to. Machine manufacturer Bausch+Ströbel is ideally equipped for this.
High-performance systems that can fill up to 60,000 syringes per hour, for example, are in demand on the pharmaceutical market. This is because frequently used medicines need to be produced quickly and efficiently for patients on all continents. At the same time, however, the development of biotechnologically produced drugs is also a challenge, process smaller batches effectively.
Examples of such systems, which require little space but offer maximum flexibility, are the KCP 5060 filling and sealing machine, in which special cleanroom robots handle the object transport, and the flexible VarioSys production system, with which a compact isolator can be combined with different machine modules. Both were developed at Bausch+Ströbel in Ilshofen. While VarioSys is used in the Small batch production the KCP is particularly suitable for the area of Packaging and process technology development interesting.
Modular system with many variation options
VarioSys is a novelty in the field of „quick changeover of machine modules in the production isolator“. The southern German machine manufacturer Bausch+Ströbel has developed this production system together with the Swiss isolator specialist SKAN. The wide range of this modular system results from the fact that a Special isolator with a wide variety of machine modules can be combined. In addition, several modules can be connected in series and set up as a line with sterilisation tunnels, cleaning machines or a freeze dryer.
Possible combinations Production modules are for example:
- a module that can be fitted with a wide variety of laboratory equipment or semi-automatic machines to suit individual requirements,
- a fully automatic machine for filling and capping (KSF 5105) or for capping (KS 4105) bottles or vials with a maximum output of 3,600 objects per hour,
- a fully automatic, intermittently operating machine for filling and closing ready-to-fill disposable syringes, vials or cartridges in nests and tubs, with a maximum output of 4,200 objects per hour (SFM 5105).
For Maximum flexibility The numerous different dosing systems also ensure a high level of product quality. For example, peristaltic pumps, valveless rotary lobe pumps for liquids or screw dosing units for powdery products can be used here; the use of single-use systems is also possible without any problems. A special air duct in the isolator also enables the Safe processing of highly effective or toxic products.
New module for processing ampoules
VarioSys is continuously being expanded with additional modules. A brand new machine module for processing ampoules was recently developed. It processes up to 6,000 objects per hour at 100 per cent IPC without any loss of performance. As with all VarioSys modules, the challenge for the design is to be based on all functions clearly arranged and user-friendly in a very limited space to be accommodated: The two-digit AFV 5105 machine has an easily visible rake transport and is also very clearly laid out in other respects - with a wide range of functions and a high output. The module is prepared for all common dosing systems, has an automatic flame igniter and can also process curing ampoules. The machine also has active suction of the ampoule spikes. The special suction unit can be accommodated both inside the clean room and in the technical area to save space.
[infotext icon]The fact that these new developments precisely meet the needs of the market is demonstrated not only by the positive response from pharmaceutical companies and packaging manufacturers, but also by an award that these technical solutions received at the US pharmaceutical trade fair Interphex (International Pharmaceutical Expo) in New York. In the category „Interphex Efficiency Champion“ The KCP filling and capping machine won this year, while the VarioSys flexible production system was honoured with the Biotech Innovation Award in New York[/infotext].VarioSys Move
While changing modules with VarioSys was already extremely easy, the new VarioSys Move extension makes work even easier for machine operators. With VarioSys Move, the Fully automated transport of machine modulest. Using an optical track, the module moves precisely into the PSI-L isolator or back into its parking position. The module is then automatically loaded in the parking position. This was demonstrated at this year's interpack using a model set-up: The B+S module for filling pouches from B+S Excellence United partner Harro Höfliger swapped. VarioSys Move can load the modules pre-programmed fully automatic into the insulator; however, it is also possible to Semi-automated solution. In this case, the modules are moved to the isolator using a control panel (remote control) - from here, the precise insertion into the isolator is again automated. One transport system can be used for several machine modules. The advantages for the customer are simple handling without the need for force, precise positioning without operator intervention and easier navigation of the machine modules, whose rollers must not be able to swivel for safety reasons. This guarantees that the right module is always in the right place.
Four workstations can be arranged flexibly
Not primarily for small batch production, but above all in the Packaging and process development the KCP filling and capping machine is used. As the same control and filling technologies are used as in the high-speed systems mentioned above, the processes developed here can easily be transferred to large systems. Together with the packaging manufacturer West Pharma (Exton, Pennsylvania/USA), the range of applications of the system is currently being significantly expanded for this use case.
The KCP is not only flexible due to the robots used for object transport, which allow the objects to be transported in every conceivable direction. The machine is also designed so that up to four work stations can be integrated in a flexible arrangement. These can be easily exchanged by the operating personnel. This means that the KCP can transport almost any common object. without long changeover times process and Various work processes can be integrated into the workflow.
Example: Filling vials
For one application, a filling station, a stoppering station and a closing station for crimp caps were set up for filling vials and an IPC scale was also integrated. The vials are transported to the individual stations by the two cleanroom robots, which can transport up to four objects at a time. In addition to individual objects, objects in a nest can also be processed. The system enables the 100%ige in-process control or optionally random samples, faulty objects are automatically ejected. In this version, the KCP can process up to 1,000 objects per hour.
But this is just one of numerous equipment and variation options. You can choose between several dosing systems for liquid and powdered products and have several capping units to choose from. Stable objects can be magazined after processing if required. The Very wide range of variations, The changeover times, for example to other object sizes or a different dosing process, are very short. The KCP is also uncomplicated when it comes to cleaning: The machine design ensures Simple, thorough cleaning and the work area, including the robot, can be decontaminated with H2O2.
Innovative and flexible filling platform
Since the start of the vial filling test system project in 2016, a wide range of challenges have been overcome, performance areas expanded and new applications identified for the use of this customised filling platform. Some of these areas of application include the assessment of objects and closure elements, evaluations of machine performance and the testing of innovative optimisations in the area of „Fill and finish“ process.
Erik Anderson, Principal Product Development Engineer at West Pharmaceutical Services, is already highly satisfied with what has been achieved so far: „Characterising the performance of all fill and finish process variants as well as all closures, (crimp) caps, vials, cartridges and syringes (for future commercial use or as prototypes) requires the use of an extremely robust, innovative and flexible filling platform.„
