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Providing Flexibility for Clinical Purposes
In the middle of 2011, Bosch Packaging Technology was appointed to deliver a capsule filling line to Almac. The pharmaceutical services supplier has significantly expanded its capacities for encapsulation at its American facility in Souderton, Pennsylvania and needed a flexible machine to address the growing demand for clinical trial studies. Bosch sold the GKF 702 with a new concept focusing on research and development in the US market. After a very short implementation time of only a few months, the project was successfully concluded in the beginning of 2012.

Almac provides a comprehensive product and services range extending from research through pharmaceutical and clinical development to commercialisation of products. The company is privately owned, with its global headquarters in Northern Ireland, and has extensive facilities in the UK and the US. Employing approximately 3000 people, Almac serves a global network of over 600 companies. Half of Almac’s clinical supply business is primary and secondary clinical packaging.Target customers include the top multinational pharmaceutical manufacturers as well as a number of smaller biotech companies. “Early in 2011 our operational team decided to expand our analytical capabilities,” said Dan Megill, Director of Operations at Almac.
For that purpose, the facility in Souderton, Pennsylvania needed equipment for higher volumes. In order to analyse the effect of tablets, Almac needed a flexible and modular machine that is able to fill different tablets into capsules. At the same time, the capsules should be filled with powder and blended for clinical analyses.

First Gkf 702 for North American Market
For its customer’s efficacy studies, it was important to Almac that the encapsulation equipment was able to produce DB-AA and DB-AAel capsules for double-blind clinical trials. Using these special capsule formats, it is virtually impossible to open the capsule without causing visible damage. This way, the service provider can blend capsules for medical comparisons and therefore prevent influence on test persons by the so-called placebo effect. Comparator products can be discreetly enclosed to improve patient compliance and tamper evident design prevents bias.
Almac's new capsule filling line includes the newly designed GKF 702, a capsule deduster, a metal detector and the KKE 1700 checkweigher. The integration of the checkweigher ensures 100 percent control of filled capsules, with a feedback loop from the checkweigher to the machine to determine if capsules are under- or overfilled. The KKE 1700 checkweigher comprehensively documents all production batches.
Optimal pharmaceutical security and a high level of productivity are the results. "Our team toured Europe and looked at the different machines that vendors were offering. We determined very quickly that the Bosch equipment met all of our requirements. The equipment provides optimal pharmaceutical security, achieves an appropriate level of blindness, and is fully cGMP (current Good Manufacturing Practices) compliant. Out of all the options we evaluated, the Bosch machinery was the obvious choice," Dan Megill explained. It is the first GKF 702 that Bosch has sold to the US market.
"In the view of Bosch, the GKF 702 is probably a mid-output machine. For us it really stands for high volumes," Megill added. The system achieves excellent efficiency. The acquisition created a balance between Almac’s European and American sites by providing paralleled capacity to handle large and smaller scale projects simultaneously.

A Close Collaboration
The GKF 702 builds on the success of its predecessor model, the GKF 701. With its upgraded performance, the machine offers many advantages for research and development. In this particular project, the challenge was to fill capsules with different tablet sizes which were originally not developed to be filled into capsules. Additionally, the time schedule for the project was very short. But the close collaboration of Bosch and Almac led to a successful conclusion. "The Bosch team helped us with their overall knowledge base, which they have never stopped improving," Dan Megill states. "They also gave our technicians and operators a very extensive training on the machine including trouble-shooting matters."
Dan Megill sees the key benefits of the equipment in its tooling for filling and easy-to-clean configuration. What is also special about the GKF 702 is its enormous flexibility. While Almac utilises the equipment’s capability to fill capsules with powder, tablets, and pellets, the GKF 702 also allows for liquid and combination fill if a provider requests these features. Its modular design offers the possibility to retrofit any filling needs and all new filling stations currently in development will be compatible with this type of machine. Small batches for research and development and clinical purposes can also be produced. Moreover, Bosch facilitates the processing of inhalable products via 'microdosing'. A vacuum dosing wheel enables a gentle and accurate filling of very small quantities of powder. The filling weights can be easily adjusted during the set up phase and throughout the production process.

"A Real Showpiece"
Dan Megill is most satisfied with the outcome of the project, "We have a real showpiece here. The customers who visit our facility are happy to see the new equipment available for their over-encapsulation needs." While Almac is expanding its clinical packaging services, further projects with Bosch may follow. "Almac's team is also examining Bosch's cartoning machines," Megill states. Almac sees the vital importance of helping clients get their drug to patients as quickly as possible while also exceeding standards. The continuous growth and development of its North American Headquarters (NAHQ) helps this to be achieved.