(Download: Sterilization Validation in PDF by Medistri)
As medical devices and pharmaceutical products progress toward commercialization, regulatory compliance and documented evidence become prerequisites for market access.
For products placed on the market as Sterile, sterility must be demonstrated through a formally validated process. Sterilization validation provides objective evidence that a defined process consistently delivers sterile products under controlled conditions.
From surgical implants and auto-injectors to prefilled syringes and pharmaceutical packaging, market access depends on the demonstrated ability to achieve and maintain sterility in a consistent, reproducible, and evidence-based manner.
Regulatory Expectations and Standards
Regulatory authorities, including the FDA, the EMA, and notified bodies worldwide require validated sterilization processes before a product can be approved, marketed, and labelled as sterile. These requirements are defined through international standards. ISO 11135 governs EO sterilization validation, while ISO 17665 defines requirements for Steam sterilization. Compliance is assessed during conformity assessments, inspections, and audits.
What Sterilization Validation Demonstrates
Sterilization validation establishes, through documented evidence, that a sterilization process, such as EO or Steam, consistently achieves a Sterility Assurance Level (SAL) of 10⁻⁶, meaning the probability of a viable microorganism remaining on a sterilized unit is less than one in one million.
This level of assurance is a baseline expectation for products intended for clinical use.
When Validation Is Required
Sterilization validation is required at initial market entry and must be reviewed or repeated when changes may affect sterility assurance, including:
- Initial commercialization
- Transition to routine manufacturing
- Change of manufacturing site or sterilization facility
- Modification of product materials, packaging, or load configuration
- Periodic revalidation
Each represents a regulatory checkpoint requiring documented justification.
Execution of Sterilization Validation
At go-to-market stage, validation must reflect the final commercial product and routine production conditions. EO and Steam validation follow structured, standards-driven workflows aligned with their respective ISO requirements.
Key elements include:
- Definition of scope, materials, packaging, load configuration, and acceptance criteria
- Bioburden assessment to support process challenge definition
- Worst-case configuration and load identification
Process qualification to demonstrate reproducible achievement of SAL
- EO: half-cycle and full-cycle studies
- Steam: heat distribution and performance qualification
Method-specific release criteria
- EO: residual EO, ECH, and EG per ISO 10993-7
- Steam: defined physical and microbiological acceptance criteria
- Final validation reporting and approval
Validation Documentation
Regulators expect a complete, traceable validation file, typically including:
- Validation protocol and rationale
- Microbiological and chemical test results
- Equipment qualification and calibration records
- Worst-case load configurations
- Final validation report
Documentation gaps may result in regulatory findings, even when sterilization performance is technically adequate.
Common Go-To-Market Risks
Validation-related delays most commonly result from:
- Inadequate worst-case representation
- Insufficient technical or statistical justification
- Late identification of EO residual constraints affecting product release
Early risk identification is critical to avoid approval delays.
Post-Market Validation and Ongoing Control
Sterilization validation continues after market entry. Validated processes must be routinely monitored, reviewed, and revalidated as required under quality system and change control procedures to ensure sustained compliance and uninterrupted supply.
Supporting Market Entry
Effective sterilization validation requires coordinated expertise across sterilization operations, laboratory testing, and regulatory compliance. A structured and integrated approach reduces regulatory risk and supports efficient market entry.
To initiate a sterilization validation project or support your go-to-market activities, visit our website here or contact sales@medistri.com.
— The Medistri Team
#Medistri
Medistri Solutions for Products in Go-to-Market Phase
In the go-to-market phase, precision and speed are critical to demonstrate regulatory readiness, secure market access, and launch with confidence.
Medistri acts as your trusted, fully integrated infrastructure partner, providing a comprehensive suite of in-house Solutions tailored to support validation, submission, and commercial readiness.
Our solutions include packaging validation, shelf-life studies, cleaning & reprocessing validation, sterilization validation, custom cycle development, laboratory method validation, support-to-submission services, post-validation training, EO-free supply chain validation, CE Mark pathway consulting, and MDR transition consulting.
By managing the entire validation and compliance process under one roof in our Swiss facility, Medistri eliminates multi-vendor complexity, accelerates regulatory timelines, ensures consistent data quality and traceability, and allows your team to focus on strategic market entry and commercial execution.
Enabling a smooth, compliant transition from development to successful product launch.
Medistri is Europe's leading independent contract sterilisation company, founded in 2006 and headquartered in the heart of Switzerland. We are a global player providing essential infrastructure that powers healthcare innovation worldwide.
We serve customers of all sizes, from startups, university projects, and research institutes to Fortune 500 corporations, across Medical Devices, Pharmaceutical Packaging, and Biotech.
Medistri supports products at every stage of the lifecycle: pre-clinical development, go-to-market, and full industrialisation.
Our fully integrated, end-to-end in-house solution allows our customers to focus on what matters most: engineering, innovation, and development, while we manage the critical backend processes.
Our synchronised departments work together to provide a complete stack of services:
- Contract Sterilisation & Validation Services
- Contract Laboratory Services
- Contract Manufacturing Services
- Logistics Services
- Consulting Services
We help you accelerate time-to-market, reduce barriers to scale, and deliver safer, more sustainable healthcare solutions to patients around the world.
Frequently Asked Questions
1. What is sterilization validation and why is it required for market access?
Sterilization validation is the documented demonstration that a defined sterilization process consistently produces sterile products. It is required because regulators only allow products to be labeled and placed on the market as sterile when objective evidence of sterility assurance is provided.
2. Why do regulatory authorities require compliance with standards such as ISO 11135 and ISO 17665?
These standards define internationally accepted methods for developing, validating, and controlling sterilization processes. Compliance ensures that validation activities are scientifically sound, reproducible, and acceptable during audits, inspections, and conformity assessments.
3. How does sterilization validation demonstrate sterility assurance?
Validation shows that the process consistently achieves a Sterility Assurance Level of 10⁻⁶ under defined worst-case conditions. This means the probability of a viable microorganism remaining on a product is less than one in one million, which is the baseline expectation for clinical use.
4. When must sterilization validation be performed or repeated?
Validation is required at initial market entry and must be reviewed or repeated when changes could affect sterility. This includes changes to materials, packaging, load configuration, manufacturing sites, sterilization facilities, or during periodic revalidation.
5. How does Medistri support manufacturers with sterilization validation for market access?
Medistri supports validation through coordinated sterilization operations, laboratory testing, and regulatory-aligned documentation. By integrating microbiology, residual analysis, and process qualification, Medistri helps manufacturers generate complete and traceable validation files suitable for regulatory submission and market approval.