When expanding its analytical capabilities, the pharmaceutical services supplier Almac required a flexible machine to address the growing demand for clinical trial studies. Bosch supplied Almac’s site in Pennsylvania with a GKF 702 capsule filling machine and further equipment, built around a new concept focusing on research and development.
Almac provides a product and services range from research to pharmaceutical and clinical development to commercialisation of products. The company has its global headquarters in Northern Ireland, and extensive facilities in the UK and the US. Target customers include the top multinational pharmaceutical manufacturers in the clinical trial supply industry down to smaller biotech companies. Half of Almac’s clinical supply business is primary and secondary clinical packaging.
“Our operational team decided to expand our analytical capabilities,” said Dan Megill, director of operations at Almac. For that purpose, the facility in Pennsylvania needed equipment that could handle higher volumes. In order to analyse the effect of tablets, Almac was looking for 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.
No influence through placebo effect
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 test persons from being influenced by the so-called placebo effect. Comparator products can be discreetly enclosed to improve patient compliance, while the tamper-evident design prevents bias.
Almac’s new capsule filling line includes the GKF 702 capsule filler, a capsule deduster, a metal detector and the KKE 1700 checkweigher. The integration of the checkweigher ensures 100% control of filled capsules. A feedback loop from the checkweigher to the machine determines whether capsules are under- or overfilled. The KKE 1700 checkweigher comprehensively documents all production batches.
“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 compliant. Out of all the options we evaluated, the Bosch machinery was the obvious choice,” Megill explained.
This specific machine was the first GKF 702 that Bosch 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 purchase of the capsule filling machine created a balance between Almac’s European and American sites by providing paralleled capacity to handle large and smaller scale projects simultaneously.
‘A real showpiece’
In this particular project, the challenge was to fill capsules with different tablet sizes which were originally not developed to be filled into capsules. “The Bosch team helped us with their overall knowledge base, which they have never stopped improving,” Megill said.
“It also gave our technicians and operators very extensive training on the machine including trouble-shooting matters.”
Megill sees the key benefits of the equipment in its tooling for filling and easy-to-clean configuration.
Another aspect is the 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 fills, in case a pharmaceutical producer requests these features. Moreover, a vacuum dosing wheel enables a gentle and accurate filling of very small quantities of powder. Filling weights can be easily adjusted during the set-up phase and throughout the production process.
“We now have a real showpiece here,” Megill said. “Customers who visit our facility are happy to see the new equipment available for their over-encapsulation needs.”