Medical Package Testing & Validation
Method Selection and Validation Structured to Protect Your Launch Timeline
Sterilization validation sits on the critical path of commercialization.
- Method selection.
- Bioburden Characterization.
- Cycle development.
- Packaging compatibility.
- Regulatory documentation.
Delays at this stage cascade.
LSO provides sterilization validation services across EtO, steam, gamma, and e-beam modalities, supported by in-house sterilization engineering and microbiology expertise. Validation strategy is structured to align method selection, packaging configuration, and regulatory standards from the outset.
Method Selection Matters Early
Choosing the correct sterilization modality affects:
Device material compatibility
Packaging performance
Sterility assurance level (SAL) validation
Regulatory submission strategy
Long-term production scalability
LSO supports early evaluation of EtO, steam (including CDER-compliant applications), gamma, and e-beam sterilization pathways. Internal sterilization engineers and microbiology specialists guide modality selection based on device configuration, material composition, and commercialization objectives.
Early alignment reduces avoidable revalidation cycles and late-stage redesign.
Standards-Aligned Validation
Sterilization validation is structured around applicable international standards, including:
ISO 11135 — Ethylene Oxide
ISO 11137 — Radiation (Gamma & E-beam)
ISO 17665 — Moist Heat (Steam)
ISO 11737 — Bioburden & Sterility Testing
Validation programs address:
Bioburden characterization
Dose audits
Cycle development
Performance qualification
Documentation traceability
All validation activity operates within an ISO 13485-certified quality system in FDA-registered facilities.
In-House & Managed Sterilization Flexibility
LSO supports both in-house and managed sterilization programs.
In-house capabilities include:
Steam sterilization (including CDER applications)
Small-lot EtO processing
Multiple EtO chambers supporting capacity flexibility
Managed sterilization coordination provides access to gamma and e-beam pathways when appropriate.
This model allows validation planning to remain method-focused rather than facility-constrained.
Packaging & Sterilization Alignment
Sterilization cannot be separated from packaging validation.
Material selection, seal integrity, aging performance, and distribution simulation influence sterility assurance outcomes.
LSO aligns sterilization validation with packaging strategy to support:
Sterile barrier system performance
Regulatory submission continuity
Reduced revalidation risk
Controlled scale-up
Validation planning reflects the full manufacturing lifecycle, not isolated testing stages.
Designed for Commercial Launch and Renewal Cycles
Organizations engage LSO when:
Preparing for initial sterilization validation
Renewing validation cycles
Expanding production capacity
Addressing method uncertainty
Seeking schedule stability
Validation programs are structured to support defined timelines and documentation clarity.
Sterilization Validation Capabilities
EtO validation (ISO 11135)
Steam validation (ISO 17665)
Gamma and E-beam coordination (ISO 11137)
Bioburden testing (ISO 11737)
Dose audits and cycle qualification
Packaging compatibility evaluation
In-house microbiology support
Certified sterilization engineers (CISS-EO, CISS-RAD, CISS-MH)
All services operate within an ISO 13485:2016-certified quality system.
Frequently Asked Questions
Yes. Modality selection is evaluated early based on device materials, packaging configuration, and commercialization objectives.
Yes. Steam sterilization and small-lot EtO processing are supported in-house, with multiple EtO chambers providing capacity flexibility.
Yes. Gamma and e-beam sterilization pathways are supported through managed sterilization coordination.
Yes. Validation programs align with ISO 11135, ISO 11137, ISO 17665, and ISO 11737, as applicable.
Yes. Packaging and sterilization planning are aligned to support sterile barrier performance and regulatory continuity.