Blue Line Sterilization Services

Blue Line Sterilization Services, LLC

Blue Line Sterilization Services (BLSS) is an ISO-certified, independent contract sterilization company specializing in fast, compliant ethylene oxide (EO/EtO) processing for small loads. They are the first and only company focused on this niche, offering rapid turnaround times to help medical devic

Blue Line Sterilization Services (BLSS) is a leading ISO-certified, independent contract sterilization company based in Novato, CA, dedicated exclusively to ethylene oxide (EO/EtO) sterilization for small loads. Established in 2009, BLSS was the first to focus on fast turnaround times and small batch processing, positioning themselves as the "FedEx of the industry" for speed, reliability, and customer service in EO sterilization. They cater to medical device companies, particularly startups, by helping them navigate the complexities of product development and accelerate their time to market. BLSS offers a range of services including turnkey validations, batch releases, sterilization project management, and support for clinical trials and product launches. Their unique "Same day / Overnight" and "Express" service options further emphasize their commitment to rapid turnaround. BLSS prides itself on its niche specialization, ensuring no conflicting priorities and a singular focus on providing the best EO sterilization for small loads. They also partner with local microbiology testing laboratories to offer negotiated low costs and fast turnarounds, supporting even the most aggressive timelines. Their agile company culture and expertise enable them to provide creative, innovative, and compliant solutions to meet client needs and deadlines.

About

**Who they are**
Blue Line Sterilization Services is an independent contract sterilization company specializing in ethylene oxide (EO/EtO) processing for small loads, offering rapid turnaround times. They are noted as the first and only company focused on this specific niche.

**Expertise & scope**
* Specializes in ethylene oxide (EO/EtO) processing for small loads.
* Offers fast turnaround times, enabling product designs to be produced and tested in days versus weeks.
* Provides support for completing validations in under 10 weeks, from start to finish.
* Offers turnkey validations and batch releases.
* Conducts comparative resistance studies.
* Provides sterilization project management.
* Supports clinical trials and product launches.
* Services include same-day/overnight, express, and rush processing options.

**Reputation / proof points**
* ISO-certified

Additional information

Blue Line Sterilization Services focuses on accelerating time-to-market or initial trials through their specialized ethylene oxide processing. They aim to help clients get final designs approved quickly and complete validations efficiently. Their service options cater to urgent needs, with processing available on the same day as receipt or early the next morning for immediate requirements. They also offer express and rush services for faster dispatch. The company emphasizes partnership, guiding clients through each step of the sterilization process.

Key Highlights

  • First and only company focused on ethylene oxide processing for small loads. Source
    “We’re the first and only company focused on this niche”
  • Offers rapid turnaround, enabling product designs to be produced and tested in days. Source
    “Produce and test alternative product designs in a few days vs. a few weeks”
  • Completes validations in less than 10 weeks, start to finish. Source
    “Complete a validation in less than 10 weeks, start to finish”

Certifications & Trust Signals

  • ISO-certified independent contract sterilization company. Source
    “Blue Line Sterilization Services (BLSS) is an ISO-certified, independent contract sterilization company”

Buyer Snapshot

Best for
  • Companies needing rapid ethylene oxide sterilization for small loads.
  • Medical device manufacturers seeking to accelerate product development timelines.
  • Clients requiring support for validations, clinical trials, and product launches.
How engagement typically works
  • Partnership approach, guiding clients through the process.
  • Focus on rapid turnaround and project management.
  • Offers specialized services like turnkey validations.
Typical deliverables
  • Ethylene oxide processed small loads.
  • Completed validations.
  • Comparative resistance studies.
  • Sterilization project management.
Good to know
  • Best when the project involves small load sizes and requires fast turnaround.
  • Best when ethylene oxide sterilization is the required method.
HQ: Novato, US
Languages: English
Timezones: PST
Status: listed

Services & Capabilities

Sterilization + Microbiology Validation

Countries: Global, Asia
Industries: Medical Devices
Pricing model: Custom pricing
Sterilization Methods Supported: EtO (Ethylene Oxide)
Validation Types Offered: Full validation (IQ/OQ/PQ), Revalidation, Other
Standards Supported: ISO 11135 (EtO)
Is Accredited: Yes
Accreditation Body: ISO
GMP Compliant: Yes
Has In House Sterilization: Yes
Has In House Microbiology: No
Lead Time Band: Start in 0-2 weeks
Rush Available: Yes
Nda Support: No
Minimum Project Size: No minimum

Additional sterilization_microbiology_testing Details

Sterilization Methods Supported
EtO (Ethylene Oxide)
Validation Types Offered
Full validation (IQ/OQ/PQ)
Microbiology Tests Offered
Sterility
Lead Time Band
Start in 0-2 weeks
Quote SLA
< 24 hours
Pricing Model
Per project
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