Ethylene Oxide (EO/EtO) Medical Sterilization Services
Custom EtO sterilization and consulting services that meet FDA and ISO requirements
Accelerate your time to market or to initial trials with solutions from Blue Line Sterilization – the only provider that’s 100% focused on ethylene oxide processing, small loads, and fast turnaround. We’re a committed partner and will help you every step of the way.
Produce and test alternative product designs in a few days vs. a few weeks
Get your final design dialed in quickly
Complete a validation in less than 10 weeks, start to finish
Service Overview
Turnkey validations and batch releases
Comparative resistance studies
Sterilization project management
Support for clinical trials and product launches
Service Options
Same day / Overnight: Ready same day as received or early next morning
Express: Ship out the day after we receive it
Rush: Processed the day after we receive it; shipped the next day
Base (Standard): Processed within 2 days after we receive it; shipped the following day
“We are deeply grateful to Blue Line for helping us with our unstable/unpredictable schedule. We would not have been able to meet our timeline without their dedicated support. Sterilization is expensive, so it’s important to get it done right and fast, and we trust Brant and his team to do just that. They are very professional and extremely easy to do business with as well.”
FAQs About Our Sterilization Services
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Yes, just tell us when we’ll receive the product (day or night) and when you need it back. We are an independent, agile company and promise a person-to-person experience with no corporate red tape getting in your way.
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We use the best—8 cu. ft. 3M Steri-Vac sterilization chambers in our 3,400 sq. ft. facility in Novato, CA. The optimal load size is 18 x 16 x 36 inches.
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The typical Batch Release will take 6-8 weeks and standard Validation will take 8-10 weeks, though it is possible to expedite and shorten these timelines. After the testing, we write and send you a customized and clear report.
Contact us for more details if you have questions; we’re happy to walk you through our processes.
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Yes, we are certified to ISO 13485 and FDA registered. Our QMS is designed to meet customer and regulatory requirements and provides an intrinsic framework for continual review, reevaluation, and improvement of our practices and services.
Browse our FAQs for more information about our services, equipment, and approach.
Contact Us
Call us at (415) 884-2935 or submit this form to tell us about your sterilization services needs. We’ll get back to you today and look forward to partnering with you.