Sterilization Management
Sterile Devices, Validated Processes
Sterilization Management is an essential stage in the development and manufacturing of sterile medical devices.
Sterilization Management
What is IT and why is it critical?
It ensures patient safety by meeting stringent regulatory and quality standards. The process involves selecting appropriate sterilization methods, validating those processes, and maintaining routine monitoring to guarantee that devices consistently reach the required Sterility Assurance Level (SAL).
Key Benefits
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Comprehensive Method Selection
Covers EtO, gamma radiation, e-beam, steam autoclave, and hydrogen peroxide plasma, depending on material and device sensitivity. -
Process Validation per ISO Standards
Includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), aligned with ISO 11135, ISO 11137, and ISO 17665. -
Microbiological Testing
Supports bioburden testing and bacterial spore challenges to establish reliable sterilization parameters. -
Traceability and Lot Control
Implements dose audits, biological indicators, and monitoring systems to ensure ongoing process control. -
Labeling and Shelf-Life Testing
Addresses packaging compatibility, expiration labeling, and validation of shelf life through accelerated and real-time aging.
Key Factors
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Sterility Assurance Level (SAL) Compliance
Ability to achieve and maintain a SAL of 10⁻⁶ across all device batches. -
Validated Processes According to ISO
Providers must demonstrate IQ, OQ, and PQ with complete documentation. -
Packaging Integrity and Aging Studies
Execution of simulated distribution and aging tests under ASTM D4169 and ISTA standards. -
Compatibility with Device Design
Consideration of materials, lumen structures, and packaging for effective sterilant penetration. -
Ongoing Monitoring and Documentation
Maintenance of sterilization parameters, lot traceability, and post-sterilization integrity.
Certifications
RexMed's Competitive Edge
RexMed integrates sterilization management as part of a comprehensive service, working with specialized partners and ensuring documented, traceable processes aligned with international standards. This approach provides clients with operational continuity and confidence in every manufactured lot.
Integrate sterilization management into your supply chain.
Schedule a call with our specialists and ensure full traceability in every batch.
FAQ
What documentation is generated?
A complete Sterilization Validation Report is created, including microbiological results and process qualification records.
Is shelf life considered in this service?
Yes. Accelerated and real-time aging tests, as well as simulated distribution studies, are conducted to validate shelf life.
Does the process include routine monitoring?
Yes. Dose audits, biological indicators, and post-sterilization package integrity checks are performed regularly.
How is process validation carried out?
Validation includes SAL definition, bioburden limits, microbiological testing, and IQ, OQ, PQ per ISO 11135, 11137, and 17665.
Which sterilization methods are covered?
Ethylene Oxide (EtO), Gamma Radiation, Electron Beam, Steam (Autoclave), and Hydrogen Peroxide (Plasma), depending on the device type.