A pharmaceutical manufacturer in Indiana requested help from Performance Validation (PV) with the commissioning and qualification of a new portable deblistering machine for use in a pharmaceutical packaging facility. This deblistering machine allows for the recovery of drug products (in tablet or capsule form) from blister cards that have been rejected for issues not related to product quality (e.g. print clarity on the blister card, etc.). The recovered drug product could then be repackaged, thereby reducing the amount of waste produced and increasing the overall profitability of the batch.
The deblistering machine operates by automatically feeding a blister card into a series of rollers. One of these rollers is equipped with a set of blades that cuts through the sealing material (aluminum foil or paper backed aluminum) and allows the drug product to be removed. Subsequent rollers then push the drug product into a collection bin and all packaging waste into a separate waste bin, all while keeping any waste out of the drug product collection bin. These rollers were custom made for each different blister card configuration. Multiple sets of rollers and the equipment’s portability mean that the machine can be used on many different products and on several different packaging lines.
Performance Validation (PV) provided validation engineering resources to both aid in the development of testing for the equipment and provide a Lifecycle approach for documentation.
- Qualification Plan: Developed a plan for the commissioning & qualification documents required and how best to achieve success.
- User Requirements: Worked with internal process engineers to determine critical user requirements to achieve optimal performance of the equipment.
- Commissioning: Developed commissioning tests including FAT and SAT for the deblistering machine as well as six (6) different sets of tooling.
- Qualification: Developed qualification tests including DQ and IQOQ for the deblistering machine as well as separate IQOQs for six (6) different sets of tooling.
- Supporting Lifecycle Documentation: Developed several documents to provide continuing support throughout the Lifecycle of the system, including critical parameter analysis, FMEA, business continuity plan, disaster recovery plan, system overview and configuration, security plan, maintenance strategy, component and system classifications, master document list, and traceability matrix.
- Project Management: Provided active leadership and communication throughout the duration of the project, helping the project team to identify and avoid potential bottlenecks as well as troubleshoot any problems that arose.
The deblistering machine along with all of its tooling sets were qualified and released for use in production. This enabled the company to achieve significant cost savings by reducing the amount of good drug product that was scrapped, particularly for certain products that carried a high cost.
The following are some of the benefits obtained from this project:
- The company was able to achieve significant cost savings related to drug product waste.
- The portable deblistering machine was available for use at the desired time to support commercial packaging.
- Potential problems were identified during commissioning and corrected before executing IQOQ, which resulted in a smoother and more efficient qualification process.
- High quality and consistent documentation was generated to support the equipment throughout its Lifecycle.
We turn critical into compliant.
Since 1998, Performance Validation has been providing clients with expertise in the commissioning, qualification and validation services areas in the life science industries. Our team thrives on the importance of quality, integrity and teamwork, giving our clients peace of mind during every step of the project.
Because PV is a 100% employee-owned company, we choose our work family very carefully, so our clients are confident they are getting the best.
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Vice President, Indiana Division Director
Performance Validation, Inc