Equipment Installation and Operational Qualification for a Medical Device Client
PSC Biotech® provided equipment installation and operational qualification support for a medical device client.
- Area: Washington, D.C
- Project Type: Installation and Operational Qualification
About this Project
The objective of this project was to provide installation and operational qualification support for a benchtop autoclave.
PSC Biotech experts supported the client by verifying the installation of all equipment, controls, and programming necessary to provide consistent sterilization of glass and wrapped items. Our experts ensured the system complied with relevant current good manufacturing practices (cGMP). We also ensured that all documents are available to enable the equipment and associated programmable logic controller to be operated and maintained safely, effectively, and consistently. We calibrated all the equipment prior to operational qualification and verified the operational aspects of the system deemed critical to its satisfactory performance.
The client is satisfied with the installation and verification and has praised PSC Biotech‘s professionalism and expertise. We are in the final stages of the project and awaiting pressure loggers to finish the qualification.
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