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Meeting a Shifting Demand for Sterilization

A supplier of both turnkey sterilization systems and contract sterilization services shares its perspective.

 

Cosmed recently built a 13-pallet, truck height (110") sterilizer.

After acquiring a contract ethylene oxide (EO) sterilization facility in Erie, PA, Cosmed Group Inc. is returning to the medical device industry.

Cosmed purchased the facility from iuvo BioScience in December 2016. Clark W. Houghtling, VP, business development and technical affairs for Cosmed, told Qmed that changing demand prompted Cosmed to reinvest in serving the needs of medical device manufacturers.

"The medical device manufacturing industry is expressing demand for increased competition and custom processing in response to changes in their businesses and in the sterilization industry," he said. "With the many corporate consolidations in the medical device and related industries, there are fewer choices available today. Further, decades-old business models are being challenged by global competition while the increasing complexity of medical devices is forcing changes in sterilization processing."

It is this "changing landscape" that encouraged Cosmed to respond, Houghtling explained. "At one time our company was among the largest contract ethylene oxide (EO) sterilization suppliers in the United States, until we divested our healthcare facilities approximately a dozen years ago. Based on the needs and requests from numerous medical device manufacturers, the time to return to this industry was right. Our approach is to identify customers and markets requiring custom sterilization processes developed around the product, as opposed to the more common one-process-fits-all sterilization business model."

Houghtling also points to a recent trend toward in-house sterilization. "This is quite a shift in momentum," he said. "Two or more decades ago there was a movement away from in-house to contract sterilization. At the same time, some companies attempted to convert some of their products to irradiation sterilization. Today, those trends are reversed."

He also sees growth in EO sterilization. "EO has grown as a percentage of the whole, and it remains the number one industrial sterilization method," he said. "In addition, companies are optimizing their sterilization processes by integrating logistics, distribution, materials, and other factors into decision making. As a result, the move towards EO from other modalities, and the ongoing investment in in-house sterilization, are evident. Of the top-three industrial sterilization methods (EO, gamma, and electron beam), the easiest to move in-house, and the most widely acceptable, is EO."

Cosmed supplies both turnkey sterilization systems and contract sterilization services. "Cosmed's 35-plus years' experience in designing, building, and operating contract sterilization facilities allows us an unrivaled perspective in operating sterilization equipment," he said. "This core competence is integrated into every piece of equipment that we build. In addition, the sterilization systems we have installed for our customers reflects not only our intimate knowledge of the equipment, but also the effective and efficient design and layout of their facilities. Along with our experience with equipment and operations comes our integrated knowledge of regulatory affairs, product flow, quality assurance, and logistics." 

Offerings such as parametric release, all-in-one processing, cycle optimization, and other related services have enabled Cosmed to offer some of the potentially fastest turnaround times in the EO sterilization industry, he added.

Iuvo BioScience will continue to operate its laboratory in Rush, NY, as a separate business entity. "Our daily courier service transports samples to its site allowing samples to be on test within hours of the completion of the sterilization process," Houghtling said. "This reduces turnaround time and provides a secure chain of custody. We recommend iuvo Bioscience as an option for our Erie customers."

Cosmed can also assist customers through ongoing support. "We regularly field technical questions that would be impossible to resolve without our working knowledge of the sterilization business and the ethylene oxide sterilization equipment. We don't simply install our equipment and then disengage from the project. Our company becomes deeply involved long term partners in the projects in which we participate."

Houghtling believes such support and efficiency will help medical device manufacturers meet future challenges. "With the rising cost of healthcare, and the new political arena, overall cost becomes an increasingly important component of the medical device supply chain," he explained. "Medical devices continue to evolve in their complexity and the sterilization industry must provide solutions for processing. The use of age-old sterilization processes designed to meet the business model of a contract sterilization service provider is inefficient and creates cost for the industry. Custom processing, top quality, fast turnaround, and superior customer service have become increasingly important in the healthcare sterilization industry." 

He also believes that Cosmed can provide manufacturers with competitive advantages such as reducing inventory, improving cash flow, and latest technological advances.

He further suggests that manufacturers have more than one sterilization supplier. "Historically, the large multi-national manufacturers opted for a single source for their sterilization needs," he said. "The expectation was that this would provide leverage on pricing, service, and quality. The exact opposite has proven true, and companies are realizing that maintaining flexibility in sterilization options is the best way to manage their businesses. We hope to be the one of the options."

At MD&M East in New York City in June, Cosmed will demonstrate its EO sterilizer control system. "As opposed to the more common, one-size-fits-all approach, our process control system is designed to replicate existing sterilization processes, addressing concerns about the impact on established processes, and reducing the cost associated with requalification," Houghtling said.

Cosmed is also inviting the industry to an ethylene oxide sterilization seminar at the Erie, PA facility in September. "The forum will focus on applied sterilization concepts, allowing our customers to connect the technical issues (e.g. process validation, cycle development, optimized lethality, etc.) with the sterilization hardware. The seminar will be held in the training room and on the floor of the sterilization facility. It will be a truly hands-on experience."

Visit Cosmed at MD&M East Booth #1562 June 13-15.

Daphne Allen is executive editor of Pharmaceutical & Medical Packaging News and a contributor to MD&DI and Qmed. Reach her at [email protected] and on Twitter at @daphneallen

Daphne Allen

Daphne Allen is editor-in-chief of MD+DI. She previously served as executive editor of Pharmaceutical & Medical Packaging News, which serves as the pharmaceutical and medical device channel of Packaging Digest. Daphne has covered medical device manufacturing, packaging, labeling, and regulatory issues as well as pharmaceutical packaging and labeling for more than 20 years. She is also a member of the Institute of Packaging Professionals's Medical Device Packaging Technical Committee. Follow her on Twitter at @daphneallen.

 

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