A customer was looking to achieve a higher level of containment in their dry granulation process as the drug they produce is highly potent and hazardous to operators. Critical to the success of the project was preserving containment during the charging, discharging and cleaning processes.
It’s all in the design detail
Fitzpatrick and Extract Technology collaborated to bring their top-quality equipment together to create the perfect solution for the customer. A Fitzpatrick CCS320 was integrated into an Extract Technology containment Isolator to deliver operator protection of <1 µg/m³.
The CCS320 was perfect for the project as it is the most compact Roll Compactor on the market and all the process parts are on the front making them easier to access.
Part of the design requirement was that the Roll Compactor needed to be assembled and disassembled inside the isolator. Models and simulated mock-ups helped to refine the design and ensure that everything would be accessible to the operators. Consideration was made of the fact that all operations would be undertaken whilst working through glovebox ports – for instance, all connections and fasteners were reviewed for accessibility and where necessary either repositioned or specialist tools were produced. The isolator design was also altered to ensure that the access points lined up with the parts of the CCS that would need to be reached.
Rapid Transfer Ports (RTPs) are used to safely deliver fresh powder and take out the granules.
Delivering on the objective
By design the CCS320 is a very well-sealed and safe machine, complying to OEB 3 & 4 containment levels, but the addition of the isolator enabled OEB 4 & 5 to be reached. This delivered a safety guarantee for the customers’ operators but also ensured the surrounding area remained clean and contamination-free.
This aligned design has meant that full containment can be achieved at all times – even during the loading and transferring stages. Furthermore, when cleaning the equipment, this containment is preserved and the operators are able to dismantle the CCS safely through the glove ports.