The Challenge

A client contacted Performance Validation requesting assistance with qualification of additions and modifications to an existing cell culture purification suite to expand the product line capabilities of a newer acquisition facility on a tight production shutdown window.

Additionally, this client requested assistance with replacement of their obsolete washers and autoclaves, expansion of their quality control lab facility, and changes to their utility systems to accommodate the resultant increased production rates.

The Solution

In the planning phase of the project, Performance Validation (PV) helped identify the differences between the validation cultures of the site and the corporate project team. With years of shared knowledge of regulatory requirements and experience with protocol development, PV was able to provide a union between the two cultures to allow a gradual adaptation of the corporate validation structure within the site’s validation framework. A more robust documented commissioning process was included earlier in the project, with leveraging being used, to streamline and shorten the qualification process.

PV performed design reviews of the project systems to provide assurance that the designed system would meet the user requirements. Upon successful design review and during subsequent installation, PV aided the client in construction walkthroughs and concurrent construction/vendor turnover package documentation review to ensure that commissioning and qualification issues would be immediately addressed. Through this effort, PV helped to reduce the production shutdown timeline.

The Results

The client was able to successfully qualify their modifications to allow for expanded product lines at the site within the production shutdown window.

The Benefits

Performance Validation offered a solution, the union of the corporate and local validation cultures, while providing preemptive support to reduce project delays. The customer was very pleased with the development and execution methodologies suggested by PV. The purification suite was qualified and released back to production as per project schedule.

Have a question on the design, development, or implementation of validation for a purification suite? Please, schedule a call with one of our subject matter experts.

Neil Enlow
Principal Validation Engineer
Performance Validation, Inc

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