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.
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:
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About Performance Validation: Performance Validation is a 100% employee-owned company has been serving the life science industries since 1988, and is a nationwide leader in providing validation, commissioning, and quality services for pharmaceutical, biotechnology, and medical device manufacturers.
We are not a virtual company, a staffing agency, or a “body shop.” Our projects are managed and staffed by our own employees. We live by our Mission, which is to provide our clients with peace of mind, and we have been doing so for more than 30 years.
For more information:
Vice President, Indiana Division Director
Performance Validation, Inc
Office: (317) 248-8848
Cell: (317) 727-8495