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

Neil Enlow
Principal Validation Engineer
Performance Validation, Inc

Posted in CQV

Donna Griffith

Director of Technical Services - Donna has over 20 years of experience leading teams in Commissioning, Qualification, and Validation (CQV). Her focus has always been on pioneering equipment management, quality control, and embracing innovative practices, such as Paperless Validation.

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Brad Henry

Vice President of Services Products - Brad has over 20 years of experience managing and executing CQV projects for the pharmaceutical and medical device industries. He has extensive experience in dry products, parenteral, facilities and utilities, and in-vitro diagnostics.

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John Underwood

Vice President of Services Delivery - With over 20 years of industry experience, John has been fortunate enough to experience all levels at PV and has provided services to the pharmaceutical and medical device manufacturing industries. He has extensive experience in dry products, parenteral, facilities and utilities, API, and computer systems.

Schedule with John Underwood