Solo Containment has designed and built a range of high containment flexible film isolators for Piramal Enterprises’ Pharma Development facility in Morpeth, Northumberland, UK.
The seven isolators cover all aspects of the granulation process and have been designed for rapid deployment into and out of Piramal’s GMP containment suite.
The design brief was for the flexible isolators to permit operation of the process equipment without the need for operator PPE (Personal Protective Equipment). This not only improves the dexterity of the operations but also minimises API contamination within the facility to assure faster changeover.
The Piramal technical team selected Solo’s HEPA filtration system with full negative pressure airflow operation. All isolators feature double zipper in-feed airlock chambers with -20pa operating pressure while the API handling chambers are operated at -50pa negative pressure and feature bag–out exit ports and crimping systems for product pass out.
As part of the commissioning work special attention was taken with SOP development. Solo Containment worked with Piramal’s EHS group to iron out ‘best practice’ work techniques to minimise risk of API track out of the flexible film isolators. The training also covered change out of the flexible film envelopes to permit cross-contamination-free set up for new development compounds.
The isolators also provide:
- A 30kg drum sub-division isolator with a hydraulic actuated drum lift and tilt mechanism;
- Comil isolator to permit API in feed, mill loading and product recovery system;
- Sieving and de-duster enclosure with fully opening equipment placement and set up door;
- Granulator isolator with innovative out feed containment system;
- Tray dryer isolator with dual position flexible containment screen to permit dryer door opening – with envelope move back for tray load/empty access;
- Two tablet compression isolators – featuring drop down panels for tooling set up.
Solo continues to work alongside the pharma solutions team at Piramal Enterprises to ensure that the film enclosures can continue to evolve into the best ergonomic layout while maximising API containment during drug development operations.