What Blue Line Sterilization Services does

Blue Line Sterilization Services (BLSS), LLC is a contract sterilization service provider founded in 2009 and headquartered in a 3,400 sq. ft. facility at 401-C Bel Marin Keys Blvd., Novato, California. The company specializes exclusively in ethylene oxide (EO/EtO) sterilization for medical devices, positioning itself as the first and only independent contract EO sterilization firm focused on small-load processing with rapid turnaround. Its equipment fleet comprises 3M Steri-Vac 8XL and GS8X sterilizers (8 cu. ft. chambers), which use fixed-volume, single-use EO cartridges paired with scrubbers that are 99.99% efficient at removing EO emissions; the facility is powered by 100% renewable energy.

Blue Line generates revenue through project-based pricing on EO sterilization processing, turnkey validation programs, batch releases, comparative resistance studies, and end-to-end sterilization project management. Service tiers range from Same Day/Overnight to Base (Standard) processing, with validation projects typically priced as a single fixed price per project covering protocol preparation, project management, testing management, and final report. Lead times run 6-8 weeks for batch release and 8-10 weeks for validation, and the company offers 24/7 receipt and processing availability while maintaining at least 60% over capacity to keep queue times measured in hours. The customer base spans startup medical device companies with dynamic development programs and established OEMs needing small-batch or backup capacity, with customer acquisition driven primarily by direct sales, word-of-mouth, and the West Coast Device Alliance referral network.

The company is led by founder and manager Brant Gard (40+ years of experience in biomedical product manufacturing and quality assurance) and General Manager Kyle Dion (MBA, joined 2017). Blue Line holds ISO 13485:2016 and ISO 11135 certification from BSI as Notified Body (Certificate MD 570749, zero nonconformities since the March 2011 first audit), FDA Registration #3009905888, California Medical Device Manufacturer's License #53818, and RoHS/REACH compliance. In February 2024 the company became a founding member of the West Coast Device Alliance alongside Eagle Medical, Pacific BioLabs, Steri-Tek, and WESTPAK. The company is privately held with no disclosed external investors or funding rounds.

Name

Blue Line Sterilization Services

Legal name

Blue Line Sterilization Services, LLC

Website

https://bluelineeto.com

Company type

Private

Founded year

2009

Operating status

Operating

Headcount range

1–10 employees

Short description

Blue Line Sterilization Services is an independent US contract sterilization provider specializing in fast-turnaround ethylene oxide (EO) processing of small loads for medical device startups, established OEMs, and clinical trial sponsors.

Ownership category

akta.pro rank

Product category

Medical Device Contract Sterilization Services

NAICS

Medical Equipment and Supplies Manufacturing (3391)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Sterilization Services & Contract Reprocessing (ETO/Gamma/E-beam providers) (HLAHANAB)

Keywords

• Contract sterilization services
• Ethylene oxide sterilization
• Medical device sterilization
• EO/EtO processing
• Sterilization validation services

Headquarters

HQ city

Novato

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Infrastructure, Operations, Personnel, Technology or R&D, Marketing or Sales, Supply Chain

Revenue model

1. EO Sterilization Processing Services: Contract sterilization services for medical devices using ethylene oxide. Services include turnkey validations and batch releases, comparative resistance studies, sterilization project management, and support for clinical trials and product launches. Pricing is project-based with tiered service options from same-day to standard processing.
2. Validation and Batch Release Services: Turnkey validation programs including protocol preparation, project management, testing management, and final report generation. Batch release typically takes 6-8 weeks, standard validation 8-10 weeks, with expedited options available.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Blue Line Sterilization Services provides contract ethylene oxide (EO/EtO) sterilization processing for medical devices, specializing in small-load, fast-turnaround runs through 3M Steri-Vac chambers. Offerings include turnkey validations and batch releases, comparative resistance studies, sterilization project management, and support for clinical trials and product launches, sold under tiered service options (Same Day/Overnight, Express, Rush, Base/Standard).

Product overview

Blue Line Sterilization Services is a contract EO/EtO sterilization company offering a unified portfolio of ethylene oxide medical device sterilization services. The core product is their EO sterilization processing service, which operates through 3M Steri-Vac chambers (8XL and GS8X models) in their 3,400 sq. ft. Novato, CA facility. Service tiers include Same Day/Overnight, Express, Rush, and Base (Standard) options, complemented by turnkey validation and batch release programs, comparative resistance studies, and sterilization project management. The company specializes in small loads and fast turnaround for medical device companies, particularly startups.

Differentiator

Problem solved

Functional benefit

Products and services

• EO/EtO Medical Device Sterilization Services Contract ethylene oxide (EO/EtO) sterilization processing for medical devices using 3M Steri-Vac 8XL and GS8X chambers, specializing in small loads with fast turnaround. Includes turnkey validation and batch releases, comparative resistance studies, sterilization project management, and support for clinical trials and product launches. Targeted at medical device manufacturers of any location.
• Turnkey Validation and Batch Release Programs Fixed-price turnkey validation and batch release projects covering protocol preparation, project management, testing management, and final report generation. Typical batch release takes 6-8 weeks and standard validation 8-10 weeks, with expedited options available. Designed for medical device companies needing end-to-end regulatory-ready sterilization documentation.
• Comparative Resistance Studies Comparative resistance study execution that quickly and efficiently generates data applicable to EO sterilization cycles at any provider, supporting medical device companies' validation activities.
• Sterilization Project Management End-to-end management of a customer's sterilization validation or batch release project at one fixed price after receiving a sample and reviewing product design, aimed at simplifying customer execution.
• Clinical Trial and Product Launch Support EO sterilization support specifically structured to accelerate time to initial clinical trials and to product launch for medical device manufacturers, leveraging Blue Line's fast turnaround and validation expertise.

Quantifiable outcome

• Queue times in hours with no load waiting more than 2 days
• +3 more outcomes

Named customers6 records

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Six partnerships are on record, tiered core and minor.

• West Coast Device Alliance (WCDA)coreStrategic or Co-development Partner · 8 February 2024Blue Line Sterilization is a founding member of the recently established West Coast Device Alliance (WCDA), a collaborative partnership among prominent California-based medical device technology service providers. The WCDA is dedicated to providing a clear pathway for medical device manufacturers from packaging design through sterile processing, leveraging collective expertise and support to facilitate efficient and successful market entry of clients' devices. Announcement made at WCDA launch event in Anaheim, CA on February 8, 2024.
• Eagle Medical, Inc.coreStrategic or Co-development Partner · 8 February 2024Founding member of WCDA, specializing in FDA-compliant assembly, packaging, and in-house hydrogen peroxide gas plasma-specific sterilization. Part of the collaborative partnership providing comprehensive medical device manufacturing services.
• Pacific BioLabs, Inc.coreStrategic or Co-development Partner · 8 February 2024Founding member of WCDA, specializing in microbiology, in vivo services, analytical chemistry, and cell-based in vitro bioassays for the medical device and pharmaceutical industries. Supports comprehensive testing needs for medical device sterilization validation.
• Steri-TekcoreStrategic or Co-development Partner · 8 February 2024Founding member of WCDA, specializing in high-volume E-beam and X-ray contract sterilizing and serving as an R&D innovation center. Complements Blue Line's EO specialization with alternative sterilization methods.
• WESTPAK, Inc.coreStrategic or Co-development Partner · 8 February 2024Founding member of WCDA, specializing in product and package testing for medical device, pharmaceutical, computer/electronics, consumer goods, food & beverages, and other industries. Provides comprehensive package validation services.
• Local Microbiology Testing LaboratoriesminorImplementation/ SI/ Consulting PartnerPartnership with local microbiology testing laboratories where Blue Line has negotiated low costs and fast turnarounds to support aggressive timelines and budgets of medical device development clients.

Scale indicators5 records

Recent moves4 records

Expansion highlights4 records

Broad incumbents

• STERIS: Public medical sterilization and infection prevention company offering EO contract sterilization among other sterilization modalities and equipment manufacturing. Comparable as a major incumbent in medical device sterilization services with overlapping customer base.
• Sterigenics (Sotera Health): Largest global contract sterilization company offering EO, gamma, and E-beam across a broad facility network. Comparable as a multi-modality contract sterilization incumbent serving the same medical device customers, though at vastly larger scale and broader geographic footprint.
• WuXi AppTec: Global contract research and medical device testing services company offering sterilization and laboratory services. Comparable as a broad incumbent in medical device services with overlapping sterilization validation and testing capabilities for similar customer segments.

Direct peers

• Steri-Tek: WCDA co-founding member specializing in high-volume E-beam and X-ray contract sterilization and serving as an R&D innovation center. Directly comparable as a California-based, contract sterilization service provider in the medical device ecosystem, differentiated only by modality.
• Cosmed Group: Contract sterilization provider offering EO and gamma services to medical device and pharmaceutical manufacturers. Comparable as a direct EO contract sterilization peer serving similar medical device customers across multiple U.S. sites.
• Pacific BioLabs: WCDA co-founding member providing microbiology, in vivo services, analytical chemistry, and cell-based bioassays for medical devices. Comparable as a California-based medical device testing services partner frequently co-engaged on the same sterilization validation projects.
• WESTPAK: WCDA co-founding member specializing in product and package testing for medical devices and pharmaceuticals. Comparable as an adjacent medical device testing peer and WCDA partner commonly engaged alongside sterilization validation work.
• Eagle Medical: WCDA co-founding member specializing in FDA-compliant assembly, packaging, and in-house hydrogen peroxide gas plasma sterilization. Directly comparable as a California-based medical device contract service provider in the same alliance and customer ecosystem.

Emerging players

• Nelson Labs: Specialized sterilization validation and microbiology testing laboratory serving medical device and pharmaceutical companies. Comparable as a focused services partner in the medical device sterilization workflow, overlapping with Blue Line's validation and batch release services.
• Noxilizer: Specialist in nitrogen dioxide (NO2) sterilization as an alternative to EO for medical devices. Comparable as a niche sterilization modality provider competing for the same small-batch, validation-focused customer engagements as Blue Line.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/blue-line-sterilization-services-llc

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Blue Line Sterilization Services