A Study in Sterilization
Vaporized hydrogen peroxide (VHP) has recently emerged as a viable sterilization method for many medical devices. The process can be set up in-house much more affordably than competing processes. And, according to suppliers that market such systems, VHP leaves no harmful residuals, can be used with a number of device and packaging materials, and offers quick turnaround times.
Jerry R. Nelson has been tracking VHP's emergence for a few years. Laboratory director of Nelson Laboratories (Salt Lake City), an independent testing laboratory, Nelson and his staff typically verify marketing claims and eliminate the conflict of interest that exists when a contractor processes and then tests the same goods. "We sterilize lab samples for customers to evaluate technology and demonstrate sterilization validation efficacy of those products for firms that purchase in-house sterilization systems," Nelson explains.
In October 2001, Nelson Laboratories ordered a VHP MD sterilizer from Steris Corp. (Mentor, OH), and the unit was delivered this summer. "We added the VHP MD for many reasons," says Nelson. "Hydrogen peroxide sterilization is growing in popularity. We have a list of customers who intend to explore VHP technology as it becomes available."
Nelson expects a healthy demand for VHP. "We believe that many customers will choose this technology for on-site sterilization. If we have a VHP MD sterilizer we can help these customers determine whether the technology works for their products. We can sterilize samples for biocompatibility tests, determine the effects of repeated processing on the products, and demonstrate sterilization process efficacy." Nelson adds that his laboratory also plans to use the unit for processing heat labile goods into sterility test suites.
In terms of cost efficiency and speed, Nelson says that "if promotional literature claims are true, we will be very pleased. Steris has priced the units attractively. Processing times are longer than steam, but considerably shorter than dry heat or ethylene oxide. Hardware costs excluded, the per-cycle costs are low. Hydrogen peroxide appears to have the additional benefit of increased operator safety."
So far, Nelson Laboratories has not worked with any companies on Conversion to VHP MD. Says Nelson: "We would recommend this technology for people who have small sterilization volumes or who have products that are time critical and cannot be processed using the other sterilization procedures in sufficient time to meet customer expectation or need. Experience may broaden the range of those who would be benefited."
Purchasing the VHP unit seems in step with Nelson Laboratories' mission, which is to implement cost reduction strategies for customers who outsource most or all of the sterilization process. "We provide the microbiology expertise, written protocols, technical and regulatory assistance, and process monitoring previously provided in-house. Validation costs become one-time product-specific development costs and routine sterilization costs become direct instead of fixed. In addition, many of the costs associated with sterilization simply go away, since we do not normally charge for protocols or on-phone consultation if the laboratory work is performed by Nelson."