VALIDATED STERILIZATION. BUILT FOR SCALE.

Contract Sterilization

Our contract sterilization capabilities include low-concentration EtO gas cycles engineered to meet stringent regulatory and safety expectations. Combined with streamlined batch release and robust commercial processing, LYNX Medical delivers consistent, validated sterilization at scale.

• Fractional Cycles
• Half Cycles
• Minimum Load Cycle
• Full Cycles

Sterilization Validation Overview

• Low & High Volume Processing

• Sterilization Cycle Development

• Sterilization Validation Support

• Low Concentrate Sterilization Cycles

• Parametric Release

LYNX Medical provides low-concentration ethylene oxide (EtO) sterilization using validated gas cycles designed to meet stringent regulatory, safety, and performance requirements across a wide range of medical devices.
Yes. Our commercial processing capabilities are designed to efficiently support both low- and high-volume production, allowing clients to scale confidently as demand grows.
We support a full range of validation cycles, including fractional cycles, half cycles, minimum load cycles, and full cycles—providing comprehensive support throughout the validation lifecycle.
Yes. LYNX Medical offers end-to-end support, including cycle development, validation assistance, and documentation to help ensure compliant, repeatable, and reliable sterilization outcomes.
Parametric release enables product release based on validated process parameters rather than biological indicator testing, helping reduce release timelines while maintaining a high level of process control and compliance.

Frequently Asked Questions

Quality & Compliance

ISO 13485:2016 Certified

LYNX Medical maintains an ISO 13485:2016 certified Quality Management System supporting our contract ethylene oxide (EtO) sterilization services. Our Pennsylvania and New Jersey sterilization facilities operate under a quality system designed to support consistent, controlled and compliant processing.

DOWNLOAD ISO 13485 CERTIFICATE