About Blue Line Sterilization Services

Minimize your time to market with the right partner

Blue Line Sterilization Services (BLSS) is an ISO certified, independent contract sterilization company in the Bay Area (Novato, CA) focused solely on EO/EtO, small loads, and fast turnaround.

We understand short timelines and the need to move quickly through each phase of the device design and development process. We even partner with local microbiology testing laboratories where we have negotiated low costs and fast turnarounds to support your most aggressive timelines and budgets.

You can be confident that we will get your sterilization done right and done fast.

blue line sterilization team

Company Background

Before our founding in 2009, no one in the medical device sterilization industry was focused on fast turnaround and small loads. We were the first and we’re proud to serve this niche better than anyone else. We were also the first to focus on the unique needs of startup medical device manufacturers.

Innovation in how we meet challenges and customer needs has a lot to do with why we succeed. Our unwavering commitment — combined with our expertise and agile company culture — enables us to think outside the box. Customers appreciate that we are creative and innovative (and always compliant) in serving their needs and meeting deadlines.

  • “When the industry had a severe sterilization cartridge shortage, our company was at risk of missing an important deadline with several lots pending routine sterilization. The team at Blue Line was not deterred by this problem and found a way to keep us on track with an alternative cartridge. They adapted our processes to be able to use it, and we got all pending lots sterilized for human use without waiting for stock to load. Blue Line’s expertise and commitment to meeting customer needs is phenomenal.”

    Tiffini W., Artelon

Who We Serve

We serve any company in any location that needs EtO sterilization services for small loads. We specialize in startups that are developing new medical devices and need a reliable partner to speed their time to market. We can also help maintain consistent sterile inventory levels and serve as a backup sterilization provider for when their larger sterilizers run low on capacity.

How We’re Unique

We stand out because of our combination of niche specialization, sterilization capacity, and customer-centric focus.

  • Our company’s sole focus and commitment has always been EO sterilization for small loads, which means that: a) we do not have conflicting priorities, and b) we are not tempted to upsell other services to those who trust us with their sterilization.

  • We maintain at least a 60% over capacity, so we can promise – and achieve – queue times in hours with no load waiting more than 2 days to get started. Large sterilization companies often have a demand of over 90% their capacity, resulting in queue times measured in weeks.

  • Customers have confidence that we will deliver as promised and help them meet their deadlines. As an independent, service-oriented provider, we’ll do what’s needed. Once you call, not only will we answer, we’ll move your request immediately and get it done.

“Blue Line has provided our startup medical device company with exceptional support, doing whatever it takes to give us timely and professional service.”
— Doug A., Nevro

Meet the Blue Line Team

  • Brant has over 40 years of experience with the manufacturing and quality assurance of biomedical products, including cardiovascular devices, antibody and DNA-based In-Vitro diagnostics, and parenteral radioactive tracers. In his production roles, Brant was responsible for the manufacturing of products as diverse as MAbs, radiopharmaceuticals, and viral antigens. As a Quality Executive, he has established and certified quality systems for several companies and achieved CE marking of their products. Since 2009, he has managed and operated Blue Line Sterilization Services.

  • Kyle has over 9 years of experience in the manufacturing and quality assurance of medical devices and stem cell products, including wound care treatments and the propagation and banking of IPSC stem cells. As a Quality professional, Kyle has improved, maintained, and certified quality systems for biotech, medical device and microbiology testing companies. As a Lead Auditor, Kyle has audited several ISO 13485 certified companies and has used that experience to enhance his knowledge of quality system organization and effectiveness. Kyle has been with Blue Line since August of 2017.