A Contract Manufacturing Organization (CMO) in Indiana specializing in bulk drug substance, formulation, filling, and finishing operations, needed to add a Single Use Bioreactor (SUB) system, consisting of a control station with integrated bag holders for disposable reactor bags to the bulk drug substance (or active pharmaceutical ingredient) production area. The single use bioreactor was the first of its manufacturer and design complexity for this site. The challenges of a tight procurement schedule and need for an original testing strategy development resulted in a project partnership with Performance Validation (PV).
Performance Validation (PV) provided a validation engineering resource to aid in the development and execution of the testing for this equipment, and to provide a lifecycle approach for documentation, including requirements specifications, component criticality assessments, and summary using the ISPE Baseline Guide, to successfully release the equipment:
- End User and Process Requirements: collaborated with internal process engineering prior to testing to establish critical process parameter ranges and critical user requirements to achieve optimal performance of the equipment.
- FAT: developed and field executed the Factory Acceptance Testing (FAT) for the control station and bag holders in Kassel, Germany while actively managing equipment issues and punch list items.
- Equipment Acceptance: interfaced with the vendor to complete factory turnover of the computer communication system software package prior site acceptance.
- SAT: developed and executed the Site Acceptance Testing (SAT), verifying proper utility and clean gas connections had been made.
- Qualification: developed and executed the qualification testing for critical process parameter ranges successfully through release for GMP use by trending the parameters over time.
- Project Management: provided active leadership and communication throughout the duration of the project, helping the project team to identify and avoid potential bottlenecks.
The Disposable Twin Single Use Bioreactor system was qualified and released on time per project schedule. This enabled the CMO to seamlessly integrate the system into the manufacturing process. The use of the Single Use Disposable Twin Bioreactor was available for production runs of the CMO’s client product as contractually required.
The completed project accomplished the following:
- The equipment was available for use at the desired time to support GMP production.
- The success of the Single Use Bioreactor project has led to negotiations to bring more of the same system on site for other clients
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Vice President, Indiana Division Director