A pharmaceutical manufacturer in Indiana requested help from Performance Validation (PV) with the commissioning and qualification of a new blister card packaging line for a new product launch, as well as facility and utility modifications to support the new packaging line. The packaging line was intended primarily for a new product that was being launched, but it would also be capable of packaging existing products.
The packaging line was divided into two segments. The first segment was a fully-automated thermoformer, which created blister cards, filled the cards with drug product (in tablet or capsule form), and sealed the product inside the card. The second segment consisted of a series of equipment that would seal the blister cards in their outer packaging, print product information, and serialize each unit. Product quality was maintained through numerous vision systems, checkweighers, and in-process tests.
Performance Validation (PV) provided validation engineering resources to aid in the development and execution of the testing for this equipment, and to provide a lifecycle approach for documentation.
The new packaging line, all tooling sets, and supporting systems were qualified and released in accordance with an aggressive timeline in order to meet the new product launch date. This enabled the company to use the packaging line for process validation and commercial packaging.
The following are some of the benefits obtained from this project:
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.
Have a question on Packaging Line Qualification? If so, please contact Brad Henry, or use our Contact Us form and one of Performance Validation’s team will be in touch.
Brad Henry
VP/ Indiana Division Director
Performance Validation, Inc
317-248-8848