How to Achieve a Flexible, High-Speed Filling Line

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1 How to Achieve a Flexible, High-Speed Filling Line White Paper Hofäckerstraße Crailsheim Germany December 10, 2014

2 How to Achieve a Flexible, High Speed Filling Line Relying on dedicated filling lines can be expensive, take up footprint space, and require extensive qualification. Find out how using just one filling solution can handle multiple products while reducing equipment investment and speeding time to market. DPS for small scale processing in an isolator Pharmaceutical companies invest up to 20 percent of their revenue in R&D. In the U.S. and Western Europe alone, this means more than 2,500 clinical studies per year. Conventional filling lines are not flexible enough to economically handle the resulting small batch sizes of 100 to 100,000. And manual filling can be prone to fault and lead to non-reproducible processes. In this context, there is rising 2

3 demand for filling equipment that can be flexibly adapted for the small batches that cutting-edge pharmaceutical producers require. Plus, the biopharmaceutical industry faces enormous pressure to accelerate time to market, improve productivity and efficiency, and reduce costs. Vaccine manufacturers face additional challenges, including varied product portfolios, pandemic outbreaks that require rapid response, and highly potent ingredients that place large demands on cleaning processes. Being a contract manufacturing organization (CMO) means successfully addressing concurrent and sometimes conflicting requirements for quality, expedited delivery time, expertise, and cost efficiency. To simultaneously fulfill these multiple necessities, modern contract manufacturers have turned to flexible fill-finish (the last process in pharmaceutical production where bottles are filled and packaging occurs) lines. In the past, it was common for a manufacturer to buy dedicated equipment for each product or container type, thereby creating dedicated filling paths to serve each product individually. Each of these lines took up costly space in a clean room and needed to be cleaned, qualified, and regularly monitored. It became clear that running high-volume product was the only economical way to run a dedicated line. Isolator Production Line 3

4 But in recent years, trends in personalized medicine have pushed manufacturers to require more versatile packaging solutions. In response, emphasis has shifted away from speed and mass production of standard dosage products to more individualized products made in smaller batches. Here, short start-up times, easy changeovers, and a high degree of automation are key considerations. The Prevalence of Single-Use Technology Demands for greater flexibility, the elimination of contaminants, and running smaller batch sizes can be addressed with single-use components that are pre-validated, pre-assembled, and pre-sterilized. These single-use items include hoses, pumps, filling needs, and tubing. Such technology was first implemented in upstream and downstream processes, such as media and buffer preparation. The single-use trend has recently shifted further downstream toward sterile formulation and filling operations. Unlike a clean-in-place/sterilization-in-place (CIP/SIP) solution that can cost upwards of $500,000 in equipment investment, there are no equipment requirements for a disposable filling system. Setting up the filling line takes about 45 minutes compared to two hours with a CIP. And clean-up time can take as much as an hour with a CIP. This can be hastened to 15 minutes with disposable solutions, which avoid the time-consuming process of cleaning, sterilizing, and validating parts that could contact product (particularly during changeovers associated with dedicated filling lines). Single use rotary piston pump 4

5 Single use filling station Using One High-Speed Filling Line for Multiple Containers As an alternative to dedicated filling lines, a more efficient, cost-effective option is to use one piece of filling equipment, incorporating disposable filling systems, for multiple types of containers. Solutions on the market today include the isolator integrated F5 system from Groninger, which is modular, compact, and offers the benefits of a high-speed line. The system offers maximum flexibility as it can process virtually all containers on the market. This makes it optimal for clinical trials and the production of small batches. The modular design allows for reproducible filling and closing of syringes, vials, and cartridges of different sizes. The flexibility of such technologies enable processing a batch of nested syringes and then running a batch of vials. 5

6 Modular small scale filling and closing production line Consider an example of a CMO using the F5 system to process small-batch syringes (1,000 pieces). A traditional high-speed isolator filling line might require up to four operators, while the F5 requires just one operator. Equipment preparation and line clearance is reduced from 10 hours to five, with no production time lost. Another solution from Groninger is the UFVN, designed for processing presterilized syringes, as well as cartridges and vials, The UFVN has an output speed of 400 pieces/minute with 100 percent in-process control (IPC). UFVN transports, fills, and closes syringes from nests. Each syringe is weighed separately and assessed. During weighing, the syringe is safely suspended onto the weight cell. The containers are lifted out of the nest only once and then replaced after filling and closing; this means no cracks or other damages to the syringe. Multiple syringe sizes can be processed after a short changeover time. 6

7 Benefits associated with both of the F5 and UFVN include: The lines are designed to handle several formulations and several containers. The lines are typically equipped with an isolator, so the infrastructure is less complicated and easier to build. A single-use filling path can be used so cross-contamination, and cleaning is less complicated. Changeover times are reduced. Personnel training is less complex as operators are always handling the same piece of equipment. Qualification is reduced as standard operating procedures are consistent. Drug time to market is reduced by years because the filling line parts are already pre-qualified and pre-validated. Summary Flexible, high-speed lines are the best solution for filling hundreds of millions of products a year. Product safety and quality can be maintained and market requests can be handled more efficiently and rapidly. For more information: Matt Clifton Business Development Manager Groninger USA LLC South Lakes Dr. Charlotte NC m.clifton@groningerusa.com 7