Project Description

Medline

Medical device manufacturer ushers in a digital future with eMaint CMMS software

Customer Since: 2019 | Industry: Medical Device Manufacturer

Excelsior Medical, LLC, a Medline medical device manufacturer, teamed with eMaint Computerized Maintenance Management System (CMMS) software experts to transition from manually recorded machine calibrations and paper-based maintenance work to an electronic data management system. By digitizing its records, the New Jersey-based company eliminated hours of logging measurements and work order completions by hand and streamlined its regulatory compliance processes and audits.

  • Configured eMaint to align with device calibration tracking and management needs

  • Automated calibration and maintenance work order scheduling

  • Optimized calibration quality control and accountability

  • Enabled the transition to a paperless environment

BACKGROUND

Based in Neptune, N.J., Excelsior Medical manufactures pre-filled saline syringes used with intravenous lines to keep them air-free, unobstructed, and clean. The company also produces pre-filled heparin flush syringes, an anticoagulant that prevents clots from forming inside of a catheter. Its critical equipment includes filling, sterilizing, and packaging machinery, which must be maintained continuously to meet the strict medical device manufacturing standards regulated by the Federal Drug Administration (FDA) and by ISO 13485, the industry’s most widely used international standard for quality management.

Excelsior Medical searched for a more efficient way to manage, save, and access regulatory compliance records and facilitate report generation for internal and external audits. Engineering and Maintenance professionals lobbied for a web-based, customizable CMMS with mobile capabilities and one that could keep pace with evolving technology.

The company chose eMaint CMMS software for all these reasons, plus its familiarity with Fluke Reliability brands, including eMaint. Excelsior Medical also plans to move toward condition-based maintenance in the future, and Fluke remote monitoring sensors and other connected devices would support this journey.

CHALLENGES

All calibration activity, including measurements and tests, had to be handwritten on paper and stored in dozens of bulky binders. This made records hard to find. Preventive and corrective maintenance data also was documented manually via paper.

IMPLEMENTATION

Christine Minervini, a manufacturing engineer for Excelsior Medical, led the implementation and administration of the eMaint software. After Minervini became aware of eMaint’s robust capabilities, she and company leaders agreed that it would make sense to leverage eMaint to manage facilities maintenance, too. This move expanded the CMMS coverage to include Excelsior Medical’s 1,233 assets and assorted spare parts such as sensors, bearings, and belts.

From the beginning, the company made a point of involving numerous department stakeholders in discussions about what to expect from the CMMS software and potential roadblocks.

“These discussions helped to trickle down the information to everyone else on the mechanic’s team, and also users from the calibration side as well,” Minervini said. “We got everyone’s opinions and feedback and really shaped this thing around them.”

Excelsior Medical participated in onsite eMaint training designed to support calibration documentation, including creating customized work orders. Company users reconfigured an existing eMaint form to align with their calibration data needs and reflect the organization’s regulatory compliance adherence.

Rather than go through the painstaking process of transferring all paper documents stored in binders to eMaint, Excelsior chose to start fresh to ensure reliable data. This way, the binders that held past calibration records would still be available when needed for third party compliance audits and historical data retrieval.

Standard operating procedures were revamped, individual work instructions reworded, and process changes brought about by digitalization incorporated. eMaint experts and Minervini tailored work permit forms and fields to accommodate required calibration measurements and testing data. Specific fields were created to meet the Quality Control department’s unique needs and vital requirements.

RESULTS

By implementing the eMaint CMMS software, Excelsior Medical completely transformed its calibration documentation processes and preventive maintenance management procedures. Minervini continues to explore the richness of eMaint capabilities and functions.

The company recently implemented eMaint at its plant in Hartland, Wis., and used the template developed for the Neptune plant for its preventive and corrective maintenance program. Minervini’s eMaint expertise enabled her to deliver the user training at the Hartland plant, which was provided virtually due to the COVID-19 pandemic.

In one year, the Neptune plant completed an impressive 927 calibration work orders, 8318 PMs, 3505 corrective work orders, and 304 facilities work orders using the eMaint CMMS.

BENEFITS

  • Enabled digital maintenance and calibration data management

  • Gained quick and painless access to audit calibration documentation records

“The eMaint CMMS was really intuitive. I was able to figure out how to update my forms myself and just rely on eMaint to really double-check everything for us.”

– Christine Minervini, manufacturing engineer for Excelsior Medical