According to David Hobson, Sales Manager for Materials Handling Technology at GEA Pharma & Healthcare, it all started with a chance encounter at the ACHEMA 2012 trade show.
While manning the exhibition stand, they were approached by the owner of a pharmaceutical manufacturing company who expressed interest in investing in a new direct compression line for a hormonal product. This unexpected encounter marked the beginning of a successful collaboration that continues to this day.
The Greek drug manufacturer sought to increase production of their highly potent product while also ensuring a safer and more efficient factory environment. They wanted to introduce new systems that would replace their existing isolator-based process. Despite the challenges, the GEA team in the UK was up to the task and reached out to the Greek company after the event. This marked the start of a longstanding partnership.
The use of isolators in tablet manufacturing requires production staff to wear protective air suits and gloves, as well as work through thick windows, making it a laborious process. GEA technicians faced the challenge of reducing the amount of isolator-based processing required while increasing batch sizes to improve production efficiency, while maintaining the necessary levels of containment and operator safety. The uniformity of the product blend was also crucial, as the final yield contained very low levels of active pharmaceutical ingredient (API). The mixing process had to be highly effective to ensure product consistency.
In addition to increasing the batch capacity size, the technicians had to overcome the challenge of formulating a product with a minuscule amount of API (0.03%). To produce a batch volume of 600 kg, for example, only 0.18 kg of active ingredient could be used, which had to be perfectly blended and evenly distributed throughout the mixture.
Overcoming Challenges: Conducting Crucial Blending and Tablet Press Trials for Potent Ingredients
Conducting blending and tablet press trials using actual product was crucial, but it presented challenges. Due to the potent nature of the ingredients, running tests at GEA's facility in Wommelgem, Belgium was not possible. Running trials with only the excipients would have been unproductive. To overcome this obstacle, GEA provided an on-site blender to the customer at no cost. A blender and an IBC were exported from Wommelgem to Greece, and a GEA operator was sent to conduct the trials. The BUCK® Prism technology, an effective aid to the bin-blending process, was used to successfully blend the low levels of API with the poor-flowing excipients - a crucial requirement for a direct compression product. The customer was pleased with the results and ended up purchasing a complete system.
GEA initially demonstrated their MODUL S rotary tablet press with a wash-off-line (WOL) Exchangeable Compression Module (ECM), a patented high containment system. All product-contact components are sealed within the ECM, which can be removed, exchanged, and washed offline. Production can resume within 30 minutes of a changeover, making the process efficient and reliable.
The MODUL S rotary tablet press was paired with additional equipment, including a Pharma Flex deduster from Pharma Technology Inc., a metal detector, and a tablet weight, hardness, and thickness tester from Kraemer Elektronik. GEA BUCK® split butterfly valves controlled by a human-machine interface (HMI) were used in the powder in-feed system. GEA also demonstrated the use of multi-tip tooling, which involved using two tips per punch (station) to double the tablet press output. The MODUL S offers unique features for this type of tooling and includes an air compensator that eliminates the risk of punch damage, unlike other tool protection systems.
To optimize product deaeration prior to compression, the dwell time during pre-compression testing was extended to 200% compared to a conventional press. A specially designed feeder and dedicated software were used to ensure optimal output.
Fostering Partnership through Communication: GEA's Solution for Contained Direct Compression Tablet Production
The ongoing two-way communication between the customer and supplier was key to the success of this project. GEA was able to provide a solution that no other equipment manufacturer could by being there for the customer and constantly engaging in dialogue. Providing the blender and enabling the customer to conduct on-site trials played a fundamental role in establishing a longstanding and valuable partnership.
GEA engineers collaborated closely with the customer's project team to design an effective system and determine the scope of supply. The project involved laboratory blending containers, blenders, various sized IBCs, and GEA technology, such as the Vibroflow® discharge technology. These features allowed poorly flowing blended materials to discharge without segregation, which was crucial when the API:excipient ratio was low. High containment BUCK® MC valves enabled dust-free product transfers. The finished powder was transferred to an IBC and then to the MODUL S rotary tablet press for direct compression. Only the initial weighing of the API prior to transfer into the blending process remained isolator-based.
How GEA's Personalized Solution enabled a Long-Standing Collaboration
By implementing the new direct compression tablet production system, the project resulted in improved efficiency and yield while enhancing safe working conditions. The system was fast-tracked, with preliminary details agreed upon within four months and equipment delivered within a year after the initial customer contact at the trade show. The removal of much of the isolator-based processing and expansion into new factory space achieved a significant increase in batch size and yield, while also improving the overall working environment.
The successful outcome of the project fostered a strong partnership between the two companies, which has continued for ten years. Thanks to the personal connection and GEA's dedication to going the extra mile, the customer has invested in additional equipment worth €1.5 million, expanding the original line and reducing batch sizes for the same product, levothyroxine, a thyroid gland drug.
This case highlights the value of building and maintaining good ongoing relationships with every customer. GEA has looked after this particular customer since their first encounter at Achema, resulting in continued business and a much-appreciated long-term collaboration. The personal touch has made a significant difference, emphasizing the importance of personalized solutions in driving success.