NEXA | EAM has executed projects in the US, Ireland, Canada, Europe, Puerto Rico, and Singapore; and continues to support projects globally with our team of dedicated professionals. We’re proud to partner with our clients, and value the collaborations we have cultivated to help them realize their operational goals—from reducing costs to improving time to market for life-changing products.
We are pleased to share the following case studies that highlight some of the key projects our team has completed for our valuable clients globally.
WuXi Vaccines Ireland:
Validation Services: IQ/OQ/PQ
Reduction in downtime due to the ability to map multiple chambers concurrently
Reduction in admin time due to the generation of validated reports including graphs and summary reports with minimum/maximum/average calculations—no human interaction required on qualified reports.
Incubators remain closed using wired validation equipment, i.e., less recovery time from opening door or loss of studies from battery failure by using wireless loggers.
Live, accurate readings throughout the test obtained remotely to ensure test was performing as expected.
Easily review trends to start/stop qualification
21 CFR Part 11 Compliant equipment
Global Pharma Facility: Vaccine Production
Reliability Services: Maintenance Optimization
Reviewed 750 total functional locations and 2,302 total work orders - resulted in identifying 52 trending correctives
Produced corrective work orders to fix trending failures
Improved corrective work order information quality concerning operations and vendors
Revised material items to reflect appropriate tasks within task lists, and to reflect necessary material numbers
Revised Standard Operating Procedures (SOPs) to bridge gaps in operations training procedures
Global Pharma Facility:
Capital Project: Maintenance, Calibration
& Spare Parts Review
Complete turnkey solution for entire Maintenance & Calibration program
Fast-track project completed in 9-months
Critical Risk Assessment (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
New Biopharma Facility:
CMMS Master Data Build -
Calibration and Maintenance
Global alignment: Based on previous successful 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.
Single-sourcing data builds eliminated any re-work, and avoided miscommunications, which may often occur with multiple vendors.
Global Pharma Facility:
Exploratory Phase Evaluation (EPE)
About Our Client
One of the largest sterile injectable facilities in the world, produces almost 25% of all sterile injectables used in U.S. hospitals. Annually the site produces more than 400 million units for patients in the U.S. and around the world.
Business Challenge: Why Client Opted for the NEXA | EPE
With such a high volume of output from the site, equipment uptime and availability are essential. Although different continuous improvement efforts were underway at the site in the areas of Maintenance, Calibration, Reliability and Spares Management, there was no overarching report on the current state, the proposed future state, and the amount of value obtainable from these different efforts. The site considered the EPE the best way to capture all of this information in the shortest amount of time.
To learn more about our approach, findings, recommendations and benefits, download the case study.
Working with [NEXA | EAM] has been and continues to be a very productive partnership. They propose real solutions, and strategically partner with us to ensure we reach our goals. They also provide excellent response times and clear evidence of achieving ROI. This makes justifying the next optimization project much easier.
Global Calibration & Maintenance Lead
[NEXA | EAM] has been working with us over the last number of years and have provided leadership and technical guidance on establishing a world-class global calibration solution. The [NEXA | EAM] team has brought high energy, focus, and direction to this program as well as unwavering enthusiasm…a key element in our overall success.
Global Asset Management Lead
Leading Life Sciences Client
Having experts come in and produce a report that showed the inefficiencies and opportunities that existed within our Calibration Program was essential in getting wider understanding and support for change at our facility. The report had an incredible amount of detail, but was presented in such a way that made it easy to digest. [NEXA | EAM] came with a great reputation and it was easy to see why.
Senior Reliability Engineer
Leading Biotechnology Client