(Download: EO Sterilization for Medical Devices in PDF by Medistri)
At Medistri, we recognize that terminal sterilization is a critical process step requiring uncompromising assurance while preserving the integrity and performance of medical devices. Our EO sterilization services are designed to integrate into your development and manufacturing operations, delivering controlled, validated, and traceable processes aligned with regulatory expectations.
Medical device sterilization is essential to prevent infections and protect patient health. At Medistri, EO sterilization is performed in accordance with ISO 11135, ensuring that each process is rigorously developed, validated, and routinely controlled to achieve the required Sterility Assurance Level (SAL), while maintaining material compatibility and product functionality.
By combining the expertise of our laboratory, sterilization, and quality teams, we support manufacturers throughout the product lifecycle. With advanced technologies, modern processing infrastructure, and in-house laboratory capabilities, we ensure that medical devices and components are sterilized efficiently, without compromising durability, performance, or development timelines.
Operational Transparency for Confident Planning with MyMedistri
Whether supporting early-stage development or routine commercial production, our transparent sterilization workflows provide full visibility from receipt through release. Clear milestones and predictable lead times allow you to plan with confidence and remain focused on product development and market expansion.
Infrastructure Designed for Complex Medical Devices
- Low-temperature EO sterilization for temperature-sensitive products
- Compatibility with diverse materials and complex device geometries
- Support for multiple packaging systems and load configurations
- Defined aeration and controlled product release post-processing
- Scalable capacity for development, validation, and routine volumes
- Efficient and reliable turnaround times within a validated framework
EO Applications Across a Broad Device Portfolio
Medistri provides EO sterilization solutions for a wide range of medical devices and components, including:
- Temperature-sensitive medical devices
- Catheters, Pacemakers
- Devices with integrated electronics or batteries
- Polymer-based devices and components
- Implants
- Surgical kits and procedure packs
- Single-use medical devices
- Metallic surgical instruments
- Ceramic-based products
- Drug–device combination products
Quality Systems Anchored in International Standards
At Medistri, EO sterilization is embedded within a certified quality management system and supported by continuous investment in infrastructure, validation practices, and technical expertise to meet evolving regulatory and industry requirements.
ISO 11135 provides the reference framework governing the development, validation, and routine control of EO sterilization processes for healthcare products. By applying this standard rigorously, we ensure that risks are controlled, processes remain reproducible, and products released from our facilities meet the highest expectations for safety, reliability, and regulatory compliance.
By following ISO 11135, we ensure that all products sterilized at our facilities are safe, reliable, and fully compliant with international quality and regulatory standards.
To learn more about Medistri’s EO Sterilisation services for medical devices, please visit our website here or contact our team at contact@medistri.com.
— The Medistri Team
#Medistri
Frequently Asked Questions
1. What role does EO sterilization play in medical device manufacturing?
EO sterilization is a low temperature process used to sterilize medical devices that cannot tolerate heat or moisture. It ensures microbial inactivation while preserving material integrity, functionality, and device performance.
2. Why is ISO 11135 critical for EO sterilization processes?
ISO 11135 defines the requirements for developing, validating, and routinely controlling EO sterilization processes. Compliance with this standard ensures that sterilization consistently achieves the required Sterility Assurance Level while remaining reproducible and traceable.
3. How does EO sterilization accommodate complex device designs?
EO penetrates breathable packaging, narrow lumens, and complex geometries that are difficult to sterilize using other methods. Controlled parameters such as temperature, humidity, pressure, and gas concentration allow uniform exposure across the entire load.
4. When is EO sterilization used during the product lifecycle?
EO sterilization is applied during development, validation, and routine commercial production phases. Its scalability allows manufacturers to transition smoothly from early-stage activities to full production volumes within a validated framework.
5. How does Medistri ensure transparency and control throughout EO sterilization?
Medistri integrates sterilization operations with laboratory testing, quality systems, and digital workflow visibility through MyMedistri. This structure provides clear milestones, predictable lead times, and documented traceability from product receipt through final release.