Design of an Award-Winning, Fully Integrated Dual Sterile Filtration Unit, With In-situ Integrity Testing and Elimination of Contamination Routes
Challenge from the Client
As part of a sterile facility upgrade, improvement of the existing, fully manual, sterile filtration stream, which consisted of two filters in series, with a number of hose connections, within a cleanroom, was required.
This project aimed to optimize the filtration process and eliminate risks involved with manual operations, and potential routes for contamination, to allow sterile filters to be operated and integrity tested with no quality risks.
The main objectives of the design were:
- To design an automated, sterile filtration system to transfer multiple products into a Grade C cleanroom and on to multiple vessels
- Allow for integrated and automated filter integrity testing, with complete protection of the sterile system boundaries during integrity testing carried out pre-sterilization, post-sterilization (preprocess use) and post-use
- Meet ATEX requirements
- Minimize the equipment within the clean room
- Allow for fully automated CIP and SIP
- Design to ASME BPE and GMP requirements
Our Approach & Solution
A multidiscipline team worked together with the suppliers of the preferred system components to translate the concept P&IDs into 3D models of the filter skid. Regular, iterative, reviews of the models took place to allow the team to work through and challenge the constraints of the design to ensure compliance with the ASME BPE and GMP requirements.
A unit was designed and built that achieved the following:
- Integrity of filters, and sterility of process, confirmed as final step prior to introduction of product (to confirm no damage during sterilization step)
- Integration with clean room panels to ensure only essential components are within the clean room
- Removal of all manual operations from the process, apart from replacement of the filter cartridges
- Reduction of plant set-up time with no off-line testing or manual setup
- Real time process monitoring
- Improved operator and environmental safety as whole operation is fully contained
Three filter skids were designed and built which were fully automated, and could undergo CIP and SIP, with hard-piped, in-situ integrity testing, with no potential routes for contamination during post-sterilization, pre-use, integrity testing.
The skids have reduced operational risks within the processing facility and enhanced the ability of the facility to maintain production and quality of output, improving the overall efficiency and cost effectiveness of the process.
The project won the inaugural Pharma Award at the IChemE Global Awards in 2018.