A Contract Manufacturing Organization (CMO) in Indiana specializing in bulk drug substance, formulation, filling, and finishing operations, needed to add a Blast Freezer system, designed to freeze up to 20 L of product from 8 °C to ≤ – 60 °C. The blast freezer 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.
- Engineering Studies: executed various engineering studies prior to execution to ensure efficient and reliable performance of the system and to eliminate possible system failures during qualification or production activities.
- Qualification: developed and executed the qualification testing for critical process parameter ranges successfully through release for GMP use by trending the parameters over time.
- Equipment Operation: developed operation and maintenance standard operating procedure and presented training to system operators to ensure proper use of the system during production.
- Project Management: provided active leadership and communication throughout the duration of the project, helping the project team to identify and avoid potential bottleneck.
The Blast Freezer 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 Blast Freezer 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.
- Thorough knowledge of system process and capabilities prior to system release has led to an efficient and reliable manufacturing process for the CMO.
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Principal Validation Engineer
Performance Validation, Inc