Breaking Free of Batch and Pallet Processing
Medical device manufacturers are constantly looking for ways to improve their production efficiency. For many of them, off-site contract sterilization is a tedious and costly proposition. Because of the long lead-time involved in contract sterilization, companies are forced to assemble large batches of product before they can be processed; this extra inventory consumes valuable warehouse space. Likewise, shipping these large batches across the country adds significant transportation costs, greater work-in-process (WIP) inventory, and delayed customer shipments. As a result of these issues, sterilization has become a major frustration for medical manufacturers seeking to launch the next groundbreaking medical innovation.
But what if there were a way to avoid these obstacles? What if, instead, medical manufacturers could enjoy an affordable, quick-turn, on-site sterilization process that satisfies their just-in-time production needs? Now, finally, they can, thanks to the revolutionary REVOX® room-temperature, vaporized peracetic acid (VPA) sterilization system.
Challenges of Contract Sterilization
MEDIVATORS, a Cantel Medical company specializing in components for endoscopic surgery, is in the process of taking advantage of just such an opportunity. Currently, the company’s facility in Conroe, Texas, sterilizes its products through an outside contractor using ethylene oxide (EO). Though still popular in the medical device industry, EO sterilization is a complex and time-consuming process. And because the methodology has some endemic health risks, it’s performed almost exclusively at third-party specialty facilities.
A MEDIVATORS process improvement team began to look at the REVOX process as an alternative to EO, since the contract sterilization stage was proving to be too cumbersome. “What happens is MEDIVATORS has to build a lot of inventory that’s basically unnecessary and unusable until that truckload can be filled,” explains John Houge, Director of Market Development for REVOX. “And then they ship the product out to the facility, the EO facility will sterilize, and then they ship it back. Once MEDIVATORS receives the product back, they have to aerate that product because the ethylene oxide is a dangerous chemical that needs to be outgassed to a certain minimum level before the product can be usable.” When considering the entire sterilization process the off-site, EO sterilization cycle time for MEDIVATORS takes between 10 and 12 days, and requires a significant amount of square footage for pre- and post-sterilization inventory storage.
By contrast, REVOX offered MEDIVATORS a completely different sterilization experience. The REVOX VPA system can handle disinfecting both small and large quantities of products much more quickly than EO—in only two to four hours—and it will be installed right on the MEDIVATORS production floor. Integrating REVOX into the production line means that the company no longer has any need for external sterilization. As an added advantage, the REVOX process runs at room temperature and doesn’t require aeration. Overall, switching from batched EO processing to REVOX will reduce sterilization turnaround times by 75%—from 10 to 12 days down to two or three days. MEDIVATORS is now in the process of making this transition.
In addition to the time saved, on-site REVOX sterilization will also significantly reduce shipping costs and the costs of raw materials for corrugated packaging. “There are also fewer labor requirements to box and palletize the product, just so it can go on a truck and be shipped up to the EO facility,” Houge notes. “It eliminates questions about scheduling that shipment, as well as concerns about weather conditions and issues that might delay or change the schedule of the EO process.” Another bonus: quality control concerns are significantly decreased because the product never has to leave the facility until it’s being delivered to the customer.
In today’s globally competitive medical manufacturing market, making operations lean and efficient is an absolute necessity for long-term success. “You have customer demand, but you don’t have to build beyond that demand. The whole idea is about making only as much product as you can sell,” Houge points out. “With REVOX, you can get closer and closer to the ideal—JUST-IN-TIME sterilization™ helps you finally achieve just-in-time production.”