The number of potent pharmaceutical compounds requiring solid dosages for clinical tests and commercial production is growing at a rapid pace. This process calls for contained environments to protect machine operators and products from cross-contamination. A containment system prevents biological agents from escaping either into the working surroundings or the external environment.
Mr. Comanns, Bosch Packaging Technology has a reputation for high safety and hygienic standards in producing and packaging pharmazeuticals. Which containment projects have been realized so far?
We sent out our first containment project already 2008 – a GKF 1700 HiProTect. In 2009 two GKF 2500 ProTect projects followed as well as two GKF 1700 HiProTect projects in 2013. One of these machines was delivered in April to our customer Penn Pharma in Great Britain, the second machine will be delivered end of September. The demand is steadily rising and we recognize a significant growth regarding highly potent pharmaceutical compounds.
Could you please explain the containment capsule filling machine GKF HiProTect?
The GKF HiProTect is suited for a wide range of filling operations, such as powder, tablets, pellets, and combination filling. Its modular design concept makes it adaptable to exact customer applications by adding additional stations. The GKF HiProTect can be equipped additionally with a statistical in-process weight control (IPK). The weighing station provides automatic feedback to the powder dosing station. Automatic processes ensure that pharmaceutical researchers and manufacturers are completely isolated from active substances during operation, maintenance and cleaning.
What must be considered in cleaning the GKF HiProTect?
Frequent product or batch changes require thorough cleaning processes. The GKF HiProTect has an integrated system that maintains the level of operator protection during cleaning. The programmable washing system stores and recalls cleaning protocols. This ensures a reproducible wash-in-place (WIP) process which can be fully validated.
What is so special about containment projects for you?
Primarily for me the projects are very complex and interesting. Every job is different and with every project we gain new experiences. This affects me personally as well as my colleagues from engineering and validation. Initially our customers were very careful with this new issue. Through the first projects we could establish ourselves as experts in the field of containment capsule filling.
Are there any future projects?
Yes, we already received orders for 2014 and 2015.
- For more information please read our article about the GKF HiProTect from Penn Pharma