Medical Device Link.

Originally Published PMPN October 2003

FORM-FILL-SEAL

Bringing the entire packaging process into the manufacturing facility is often vital for medical device companies seeking to reduce costs, optimize sterilization, streamline supply-chain resources, and diversify product opportunities. As an innovative manufacturer of more than 2000 proprietary disposable products for cardiology and radiology procedures, Merit Medical Systems Inc. (South Jordan, UT) needed to support its growing business by implementing a more-efficient packaging solution that would maintain product integrity, while driving down business costs. Consultation with long-time packaging machinery supplier Multivac led Merit to transition from a two-conveyor-driven process that focused on filling premade packaging to a customized R530 thermoform-fill-seal solution that creates specialized medical kits.

"Working with Multivac's medical team helped us reengineer our packaging process into a streamlined system that takes up less space, saves time and money, and helps us meet a continuous increase in product demand," says Larry Sommer, senior packaging engineer for Merit Medical Systems. "The team worked closely with us to develop packaging prototypes, resulting in a Tyvek top blister pack for our custom kits."

A growth in demand for specialized tubing kits, catheters, and angiographic needles prompted a rethinking of Merit's current packaging process, with careful focus on what processes could be performed more efficiently. Another goal Merit was aiming for was the establishment of a positive brand perception that it felt customized packaging would provide.

Assessment also revealed new goals to reduce overhead, material, and labor costs of Merit's diversified product line. The investment in the customized R530 rollstock machine and new packaging process seemed like the optimal choice for the Utah facility. With Multivac's medical packaging consultation, Merit decided to integrate the packaging process within their manufacturing line to more adequately secure product integrity with an advanced thermoform packaging system, incorporating quick-changeovers to meet market needs. The new process eliminates reliance on expensive premade Tyvek pouches filled in the facility, which required many steps and unnecessary expenditures.

"A change in product demand presented the opportunity to rethink the way we were doing business," says Sommer. "We wanted to transition our conveyor filling process into a streamlined, reliable, and repeatable thermoform solution that provides more-robust sterile barriers and package integrity. We put our trust in Multivac because they are an experienced medical packaging equipment supplier with a tremendous amount of industry credibility and experience."

The customized R530 system replaced Merit's conveyor system in the approximate 40,000-sq-ft cleanroom facility, taking up less floor space, manpower, and company resources while offering the capability of producing millions of medical kits per year. Multivac added three premounted forming dies to support different packaging sizes, with rapid, programmable changeover technology that automatically adjusts to up to 47 different packaging heights. This advanced system is able to provide the repeatability and package quality that meets sterilization requirements needed to optimize medical product performance.

In addition, a new in-line Bell-Mark labeling system was installed to perform flexographic and thermoform transfer printing on packages prior to sealing with a hospital's name, catalog number, and expiration date.

"Multivac's engineering know-how allowed us to incorporate an extended loading area to support our product offerings as well as manufacturing personnel," says Sommer. "With our new system in place, we now have the flexibility to increase productivity levels of diverse products with accurate labeling and ensure optimal sterilization, maximizing our return on investment," says Sommer.

From the start, Multivac and Merit maintained a close-knit relationship. Visits to other Multivac cleanroom customers with similar thermoform systems allowed Merit to see how the machines worked, giving them a firsthand look at positive results that could be achieved within their own operation.

"Multivac was committed to helping us with its experienced consultants, prototyping know-how, and validation experience," says Sommer. "Merit is in a very competitive market for angioplasty and angiography kits, and we are delighted to work with a partner that took on our business goals as its own to help us stay ahead of the competition."

Multivac provided preliminary validation of Merit's R530 system and provided floor space at its Kansas City facility for Merit to perform IQ and OQ process validations, saving Merit a great deal of time in the start-up process once the machine arrived at its Utah facility. Merit's production supervisor, packaging engineer, and maintenance personnel will undergo training at Multivac University for complete machine orientation. Merit will rely upon 24/7 technical assistance and support for troubleshooting, service, and parts replacement.

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