The Challenge

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.

The Solution

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.

  • Change Control: Wrote and managed a change control for an existing product transfer onto the new packaging line.
  • 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 process parameter ranges and critical user requirements to achieve optimal performance of the equipment, facilities, and utilities.
  • Commissioning: developed and executed commissioning tests including FAT and SAT for the machines, vision systems, 20 thermoformer tooling sets, 15 blister card sealer, and serialization systems.
  • Qualification: developed and executed qualification tests including DQ, IQOQ, and PQ for the machines, vision systems, 20 thermoformer tooling sets, 15 blister card sealer, facility & utility changes, and serialization systems.
  • Supporting Lifecycle Documentation: Developed several documents to provide continuing support throughout the lifecycle of the system, including component classification, master document list, traceability matrix, business continuity plan, disaster recovery plan, and FMEA.
  • Validation Readiness Assessment: Consulted with client resources from several departments to verify that the equipment was completely ready for process validation.
  • SOP: Wrote a new SOP detailing the proper setup and operation of the equipment and instructions for changeover between two tooling sets.
  • 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 Results

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 Benefits

The following are some of the benefits obtained from this project:

  • The packaging line was available for use at the desired time to support both process validation and product launch into commercial packaging.
  • Potential problems were identified during commissioning and corrected before executing IQOQ and PQ, which resulted in a smoother and more efficient qualification process.
  • High quality and consistent documentation were used to support a successful NDA with the FDA.

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?  Please, schedule a call with one of our subject matter experts. 

Brad Henry
VP/ Indiana Division Director
Performance Validation

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