Blue Line Sterilization Services: Offering Quick, Customer-Centered EO Sterilization Services

One of the most significant processes in developing a medical device is opting for the right kind of sterilization method to ensure device safety and eliminate harmful microorganisms. The choice of an inappropriate method can infect patients, disrupt marketing clearance from the FDA, and put a stop to a device’s commercialization. For several decades, manufacturers have relied on ethylene oxide (EO/EtO) for sterilization purposes. Unlike steam and dry heat sterilization that distorts the functionality and form of several medical devices, EO/EtO sterilization can easily be applied to plastic and electronic devices. This vacuum-based process efficiently sterilizes all the surfaces of most medical devices, making it one of the best processes to sterilize heat- and moisture-sensitive devices.

Spearheading the medical device sterilization industry is CA-based Blue Line Sterilization Services (BLSS). The company combines a customer tailored approach with industry-leading speed to deliver cost-effective, responsive contract EO/EtO sterilization services for small loads. “We always strive to minimize the impact of sterilization services by reducing the time it takes to complete the process and thereby reducing the time to market,” states Brant Gard, the Owner of BLSS.

Even though EO sterilization has been a popular choice for several medical device companies, most people lack the know-how about the process and require proper guidance in moving forward with the sterilization cycles. Furthermore, the increased time to market is another concern that device manufacturers need to overcome as large sterilization service providers take almost three months to complete the process. In contrast, BLSS reduces the product’s time-to-market by completing an entire turnkey validation in ten weeks or less. The company manages the project for clients by assessing their unique devices and formulating the best path forward to sterilize them, thus offering end-to-end testing, reporting, and sterilization services.