New Biopharma Facility

Our client, one of the largest pharmaceutical companies in the world, is building a new facility on the site of their existing vaccine production plant. 

Having established a successful working relationship with the Client based on other on-going projects the team had completed on the site, we were hired to build a maintenance and calibration program into the client-supplied CMMS (ProCal for calibrations and SAP for maintenance). 

The challenge our client faced was that the current site structure did not have the manpower or expertise to complete this system build in the time required for the product to go into Emergency Use manufacturing. The client also wanted to single-source the calibration and maintenance master data builds to improve quality, reduce re-work, and standardize the approach to data gathering, data building, and data reviewing. 

Since the work was related to a vaccination ramp-up, the project needed to move at warp speed. This was the first project of its kind, and our team mobilized quickly, effectively, and adhered to all aggressive project timelines. We also had to push for engagement early on to gain top-down buy-in as it was critical to the project’s success. Another challenge addressed was transitioning from a vaccine line to therapeutics, which required that our team update the work that had previously been completed. 

Key Project Details

• Project Type: CMMS Data Build – Calibration & Maintenance
• Location: Durham, NC, USA
• Project Costs: $554K+ (2 phases total)
• Project Duration: 10 months total (5 months to go-live / 5 months for data cleansing & optimization activities)
• Staff Assigned: Project Manager CMMS Engineers Maintenance Engineers Calibration Engineer

Completed over a 10-month accelerated project timeline, our team successfully executed the following services:

Calibration

• Complete turnkey solution for the calibration program
• Criticality risk assessments
• Calibration interval analysis
• Calibration plans & task lists

Maintenance

• Complete turnkey solution for the maintenance program
• Maintenance plans & task lists

CMMS

• Complete master data build for calibration, maintenance & spares
• System training

Spare Parts

• Identification and development of equipment BOM’s & spare parts

Results

Efficiency Benefits

• Having conducted previous projects across the client’s network, we had the knowledge and connections to ensure standardization in all work performed.
• Single-sourcing the calibration and maintenance master data builds improved quality, reduced re-work, and standardized the approach to data gathering, building and reviewing.

Quality Improvements

• Single-sourcing data builds eliminated any rework, and avoided miscommunications, which can occur with multiple vendors.

Migration to Paperless

• This will be a “digital day one” site for calibrations, and is rapidly moving to paperless maintenance activities across the site.

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.