Solutions for Tomorrow's Pharmaceutical Industry

International experts and users from all sectors of the pharmaceutical industry met from 11th to 14th October at the groninger Technology Symposium in Crailsheim.

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The symposium is held every three years – this time in two sessions over two days to satisfy the great interest of more than 220 attendees. The symposium focused on the challenges currently facing the pharmaceutical industry. Aside from information on current trends and technologies, the symposium also served as a showcase for groninger's latest innovation and further developments – like the FlexPro 50 product series.

Like many other sectors, the pharmaceutical industry is also in the midst of a trend towards greater specialization in medicines, that result in smaller batch sizes and application systems that can be safely and easily used by patients. Georg Rößling, Senior Vice President, PDA Europe (Parenteral Drug Association) and one of several eminent keynote speakers, launched the groninger Technology Symposium by viewing these trends in a wider market context and outlining their impact on pharmaceutical production.

 

Pharma world is turning

As a growing number of countries are building their own production facilities for injectables, it puts pressure on existing manufacturers. The increasing demand of biotech products like monoclonal antibodies and future gene therapies has also changed the manner of production and administration. As Rößling explains: "We are talking about medication developed for a small group of patients – even down to single doses. For the manufacturing industry, like fillers for instance, this means orders of diminishing quantities, which of course still need to be produced in rigorously aseptic conditions." Years ago, Rößling remembers discussing the question of whether productivity or production monitoring would become the key design criterion for filling machines with Chief Technology Officer Volker Groninger. At the time he tended towards speed, while Volker Groninger emphasized monitoring. "Today I have to agree with him" conceded Rößling referring to the trend towards personalized medication – not only in drug composition, but also in administration – by the patient himself thanks to smart application systems. This demands constant monitoring by the manufacturer of which medication is destined for the respective patient – in turn calling for production solutions that are flexible, reliable and capable of processing large data volumes. Rößling thus concludes that pharmaceutical production has also stepped into the age of Industry 4.0 (Internet of Things IoT).

 

Boldly opting for standard

Thorsten Häfner, Director Business Development at groninger, picked up on this line of reasoning and explained what this means for machine builders like groninger. "Smaller batch sizes often demand high flexibility in processing different containers and products on the same line. Ensuring sterility in these circumstances without compromising productivity calls for a flexible filling system that can be easily re-equipped for the most important standard containers", states Häfner and led into the practical part of the symposium. "Our answer to this challenge is the FlexPro 50, which we presented for the first time at the Achema 2015. Two of these machines – one line for bulk production with an hourly rate of 3,000 units and a line for up to 4,500 nested vials – can be experienced here at first hand, in production, with a format change and in isolator conditions." As a market-leader in developing and building special machines for filling pharmaceutical, cosmetic and chemical products, groninger is exploring new roads with the FlexPro 50. Besides customized special machines, the company also offers standard machines. "groninger is morphing from a builder of purely specialized machines to one offering modular standardized machinery equipment", says Thorsten Häfner. The wheel didn't have to be reinvented for the FlexPro 50: all technological solutions are drawn from the existing and proven groninger portfolio. The new aspect is the configuration of an overall system consisting of several components, which can be put together as required by our customers. Häfner: "Together with our partners like Franz Ziel and Martin Christ yet also producers of containers and applications systems, we have developed a modular solution that can cover the latest requirements on the market."

 

Shorter lead times

And of course, groninger continues to build customized machinery, but: "flexibility is becoming increasingly important with the lead times becoming shorter and shorter. The FlexPro 50 is a turnkey, all-in-one system that makes no comprises, either on quality or processes", ensures Häfner. "The customer benefit: standard solutions like this are not only versatile, but also available far sooner. Lead time from placing an order with groninger to going live has been reduced by up to 50% over conventional lines. As Häfner confirms: “All these features convince clients to make there decision for FlexPro 50. Like the US company Alexion for instance, which recently set up production facilities in Ireland. Medicine for ultra rare diseases (20 or less in a million people) are produced there. Brian Cullinan, Associate Director, Alexion Ireland, explained in his symposium speech why his company opted for a FlexPro 50 and how the system was installed. "The core requirement was of course the ability to process biotechnical products in small quantities of two to twenty liters. The product was to be filled into pre-sterilized vials of as many different shapes as possible in clean room conditions." System installation was to impact as little as possible on existing production processes at Alexion. As Cullinan remarks: "Preference was given to providers, who could offer a complete integrated package, from documentation and installation to training Alexion employees. "We made exactly the right choice with groninger and its partners," he adds, praising the good cooperation throughout the project.

 

Hands-on Technology

During the groninger Technology Symposium visitors had ample opportunity to take a closer look at the details and possibilities offered by the FlexPro 50. The groninger experts took time to answer the many questions and demonstrated the various functions in live operation.

Yet not only FlexPro 50 was highly rated by visitors from 27 different countries. A further highlight was the high-speed filling line UFVN with a rate of up to 24,000 units per hour and 100% in-process-monitoring for no compromises on performance. In addition, the SMM010 was designed to attract attention to the assembly of safety devices for disposable syringes and syringe, vial and cartridge labeling. This also applied to partner company exhibits: for instance Christ brought its own six ton freezer dryer to Crailsheim. Freeze drying is enjoying increasing popularity in pharmaceuticals, given that products can then be stored for longer and take up minimum space. The ingenious aspect of the Martin Christ solution: the freeze is equipped with a fully automated, wireless loading and unloading shuttle robot. At the Technology Symposium groninger partner Merck focused on the subject of "single use" and also demonstrated the function of groninger's newly developed single use rotary piston pump on the FlexPro 50. This often saves the machine builder meticulous cleaning, especially after product changes and protects against contamination from preceding products manufactured on the line. Franz Ziel, exclusive partner for the isolator technology within FlexPro 50, focused on its compact isolator technology at the symposium: inflated with compressed air, the gaskets ensure hermetic sealing of the interior and reliably protect the product and machine operator during both aseptic and aseptic-toxic processing. The many suppliers of traditional pharmaceutical primary packaging – i.e. vials, disposable syringes, application systems and similar products – also appreciated the opportunity to forge new contacts on their own info booths at the Symposium, including BD Medical, Ompi, Schott, West and Nipro.

 

Successful exchange of ideas

As Jens Groninger, CEO of groninger & co. GmbH remarked with delight: "Our customers appreciated the presence of our partners," and expressing his high satisfaction with the Technology Symposium overall: "The event far exceeded my expectations. The good response on the part of our customers and many intensive discussions in particular, show that our aim of exhibiting technology you can touch has struck a chord." No presentation can match that: "Live demonstrations are what prompt discussion with and among customers and always provide us with a lot of good ideas." In turn, it motivates groninger employees: "I am very proud of my team and how everyone pulls together", says Groninger. "And I'm not alone; our customers also feel the dynamism, passion and intensity with which our employees identify with their job."

Markus vor dem Esche, West Pharmaceutical, one of the symposium attendees can only nod in agreement: "The symposium organization is super. You always feel well looked after and there are plenty of competent people to advise you." This, according to vor dem Esche, also helps in better advising his own customers. Karsten Heuser, Head of Device Development, LTS AG, is also pleasantly surprised, admitting that: "I arrived here with rather modest expectations. I was very impressed to see everything live in production."

For more information, visit www.groninger.de.

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