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Autoclave Revalidation Project

Duration– 9 months

Overview

During a concurrent project onsite at a major international pharmaceutical corporation, Mangan personnel were asked to evaluate the client’s Autoclave Program as a result of a regulatory audit.  Our existing relationship with this client enabled Mangan personnel to quickly react and respond to the client’s needs.

Strategy

As a result of the Autoclave Program assessment by Mangan personnel, it was determined that a new strategy was required to best satisfy the strictest international regulatory requirements.  A specialized Mangan resource was tasked with developing a robust Autoclave Program and Strategy for dry goods to support future successful audits.  The Mangan resource created a project plan for the client including rationale for the project, scope, timelines, execution strategy, and deliverables.

Process

The project plan and execution strategy was submitted to the client for review and approval and included over 200 Autoclave cycles to be executed with supporting data analysis.  A risk assessment was performed for all items to be Autoclaved and a family approach was implemented where applicable.  This approach was taken to reduce the total number of runs required and enabled the project to be completed within a tight manufacturing schedule with minimal interruption to the Client’s established activities. 

Result

A successful overhaul of the client’s Autoclave Program was established.  In addition to successful completion of Autoclave runs, and supporting data analysis, Mangan personnel were able to update client documentation to support further efforts if needed as well as create templates for testing and standardizing the clients approach to Autoclave Testing.  The project was completed within the originally scheduled timeline, without disruption to the client’s manufacturing space.