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.
Brant Gard, Founder & Manager
“Our knowledge is key in helping mitigate the challenges many of our clients have when they develop products but may not know how to sterilize them and what it takes to do so,” adds Kyle Dion, the Quality Manager at BLSS.
BLSS has a large 3,400 sq. ft. facility that houses sterilizers and aerators qualified and standardized according to the ISO 13485 and ISO 11135 certifications. At present, the company has six operational sterilizers, four of which are the 3M 8XL, and the other two are the 3M GS8X models with installation and operation qualifications. Additionally, the company operates 3M Steri-Vac sterilizers to maintain the capacity to keep queue times to a minimum. These sterilizers are highly recommended for safety, consistency, and reliability by both users and regulatory authorities.
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
Equipped with such robust tools, BLSS works with the customer to evaluate the clients’ devices then helps clients design the sterilization cycle. When a shipment comes in for sterilization, the company matches the cycle specification, runs the cycle, reviews the cycle data, and returns the sterilized products. BLSS offers a turnaround time of less than a day to three days to ship the sterilized devices to the clients.
Since its inception, BLSS has maintained its ability to turn product sterilization loads faster than many in the industry and helped minimize clients’ costs for sterilization services. In the coming years, the company envisions expanding its capacity with more sterilizers. “We go the extra mile to deliver the complete value of our services and help clients meet all their deadlines. We are committed to meeting our agreed upon delivery date, and continuously monitor our performance reports to improve our capabilities,” concludes Clay Gard, the Operations Manager at BLSS.
Description Blue Line Sterilization Services offers EO/EtO sterilization services focusing on start-ups, new medical device companies, and supporting established product lines. The BLSS approach ensures faster time to market and complete guidance and consultation to all clients. The company works with its clients to develop a customized process based on individual needs, ensuring a responsive, consistent and cost effective experience that gets its client's product to market without delay. Blue Line Sterilization Services is committed to meeting the highest standards of quality while consistently providing its customers with reliable, fast, and personal ethylene oxide sterilization and consulting services
This content is copyright protected
However, if you would like to share the information in this article, you may use the link below: