Wash-in-Place (WiP) and containment machines have to satisfy the very highest safety standards in tablet production. Closed systems of this kind protect machine operators against highly active materials. Fette Compacting experts recently proved they can reliably meet these quality requirements for a world-leading pharmaceutical manufacturer.
The assignment involved the production of tablets at OEB Level 5. In other words, the operator’s exposure to dust and material residues must be less than one thousandth of a gram per cubic meter during an eight-hour working day.
Dust and other residues inevitably arise if the raw material is fed into the machine as powder or granules and then compressed at high speed. Protecting the machine operator against toxic and highly active substances means that these materials must not leave the process chamber under any circumstances. That’s why they are kept in the machine by permanent negative pressure. Product residues that become deposited in the tablet press during production are diluted with water containing special cleaning additives and then flushed out – that is the principle behind “Wash-in-Place” (WiP).
Simple operation is an essential requirement
Above all, the machine must be easy to operate for the user. That is also an essential prerequisite for ensuring the safety system works perfectly and the entire process runs efficiently.
Handling was a crucial factor in a large pharmaceutical customer’s decision in favour of our solution. For example, we have integrated gloves into the isolator to enable users to carry out manual work without having to interrupt containment.
If a die is damaged, it can be exchanged immediately without delay. The entire periphery of the 1090i WiP machine is located in an isolator with two window flaps. The isolator can be moved, which makes it flexible when needed. Furthermore, Fette Compacting offers a complete system with air management, connected WiP center, control unit and filter systems – all precisely matched and coordinated.
Complete service from planning to acceptance testing
The technology of a solution is not the only factor. Planning is also crucial: the entire installation has to ideally meet the needs of the customer. That can only be achieved if there is transparent and direct communication during the planning phase.
In the case in question the customer examined a comparable machine under production conditions at another pharmaceutical manufacturer’s plant. Although our project manager was present, he initially remained entirely in the background and only later answered the customer’s specific questions in detail. That enabled us to further strengthen the positive impression that the customer had gained from our other projects.
Acceptance testing was carried out at the Technikum at the Schwarzenbek site. Here, too, the customer’s project managers were constantly involved. Subsequently the machine was installed at the customer’s plant and checked in accordance with the established Site Acceptance Test (SAT). Among other things, that includes an extensive safety test and a complete test run with the product.