Packaging Line Qualification


The Challenge

A client contacted Performance Validation requesting assistance with qualification of a new product packaging line for a bagged dry product to allow for serialization and reduction in personal protective equipment (PPE) required by operations. This system was to be installed in a parallel room with tie-in to the existing packaging line to allow for continued packaging operations during construction and qualification activities.

The Solution

Performance Validation (PV) helped write and execute a qualification package for the new bagging system with intermediate quality reviews and sign-offs to allow the existing interfaced equipment to remain in production. PV provided qualification of the upstream process diversion system to allow for the existing bagging system to divert product between the old and new system as required until the integration of the new system and eventual removal of the old system.

PV also provided support of the installation of the downstream moving conveyors that would allow the alternation between the new and old system to feed the product palletizing equipment. Since both systems would be inoperable during installation, only a 24 hour shutdown window was provided. Upon completion of installation by construction and controls integration by the vendor, PV personnel worked quickly and effectively to test and adjust the system to meet the client’s operational needs. Despite several installation delays, the system was returned to operation at the end of the short shutdown.

The Results

PV was able to successfully qualify the new packaging system while allowing for usage of the existing packaging system without production interruption. The newly qualified system and associated equipment allowed for the client to reduce their PPE requirements for packaging operations.

The Benefits

The customer was pleased with the structured phased qualification / re-qualification plan executed by PV to allow for the new system to be installed and qualified while still maintaining packaging operations via the existing qualified system.

Have a question on the design, development, or implementation of validation for a packaging system. If so, please contact us using use our Contact Us form and one of Performance Validation’s team will be in touch.

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:
Neil Enlow
Principal Validation Engineer
Performance Validation, Inc
Cell: (317) 341-2819