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:
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:
For additional information, contact:
Brad Henry, Indiana Division Director
5420 W Southern Ave, Suite 100
Indianapolis, IN 46241