Global Pharmaceutical Facility

Our client is a global pharmaceutical company with a sterile injectables manufacturing site located in Pennsylvania, USA.  

The client required a turnkey solution for their entire Maintenance and Calibration program for a new construction project, including a Spare Parts review.  

To ensure the project was aligned with other sites’ maintenance and calibration systems and similar equipment requirements, the team utilized the client’s best practices. This allowed for the processing, compliance and audit corrections to be easily shared and corrected seamlessly across the client’s entire network.

Key Project Details

• Complete turnkey solution for entire Maintenance & Calibration program.
• Fast-track project completed in 9 months.
• CRA involved the review of 2,000 unique instruments, identifying 16% were product critical.
• Resulted in the build of 1,231 calibration plans.
• 1,070 spare parts assessed for criticality, stock/non-stock and added to maintenance system.

The NEXA team served as the single point of accountability for the client to ensure the efficient execution and oversight of this critical project.

The Maintenance (SAP) activities included 520 equipment profiles and 731 maintenance plans reviewed and written, which fully incorporated reliabilitybased maintenance techniques; as well as completed BOMs (Bill of Materials) for all the equipment to ensure the availability of spare parts when needed. The Calibration activities involved a full Criticality Risk Assessment (CRA), which included the review of nearly 2,000 unique instruments, and identified that 16% of the instrumentation was product critical.

This resulted in the build of 1,231 calibration plans. The team completed this main scope of the project on a tight schedule finishing the work in 9 months for a project that typically takes 18-24 months. The ongoing work involves completing the spare parts review and collection. To date, 1,070 spare parts that were assessed for criticality, stock/non-stock, and added to the maintenance system. Critical spares have a direct impact on equipment downtime. If parts are unavailable when equipment breaks then it can lead to excessive loss in production.

About Transcat

Transcat has over 60 years of experience servicing some of America’s largest companies in highly regulated industries. Our experienced teams provide equipment and asset management solutions for high-cost-of-failure environments such as pharmaceutical, biotechnology, medical device, and other FDA-regulated organizations throughout the US, Canada, Ireland, Europe, and Asia Pacific.