(Download: Routine Sterilization in PDF by Medistri)
As medical devices and pharmaceutical products transition into the industrialization phase, manufacturing activities evolve from development-driven execution to stable, repeatable production under controlled conditions.
At this stage, sterilization is no longer an experimental or validation-only activity. It becomes a routine industrial operation that must demonstrate:
- Process consistency
- Regulatory compliance
- Predictable lead times
- Full traceability across the supply chain
Medistri supports this transition through an integrated sterilization, laboratory, logistics, and digital infrastructure operating across Switzerland and Hungary, enabling manufacturers to move from first industrial batches to sustained commercial production.
Industrial Scale and Market Coverage
Medistri’s routine sterilization infrastructure supports industrial-scale operations, with more than 90,000 pallets sterilized annually across its Switzerland and Hungary facilities. These activities serve products intended for both European and United States markets, covering a broad spectrum of medical devices, pharmaceutical products, and pharmaceutical packaging systems. The platform is designed to accommodate the full lifecycle of customer needs, from small-scale production supporting newly developed or recently validated products to high-volume routine sterilization for established commercial manufacturing.
This combination of scale, regulatory alignment, and lifecycle flexibility ensures that manufacturers can rely on Medistri for consistent, compliant, and globally deployable sterilization capacity.
Regulatory Scope of Routine Sterilization Operations
Routine sterilization activities performed during the industrialization and commercial production phases are executed within a fully controlled regulatory framework aligned with applicable international standards and regional requirements. Sterilization processes are validated and routinely operated in accordance with recognized standards such as ISO 11135 for ethylene oxide sterilization and ISO 17665 for moist heat sterilization, with supporting laboratory activities conducted under relevant quality and testing standards.
Operations across Medistri’s Switzerland and Hungary sites are performed within certified quality management systems aligned with ISO 13485 and applicable GMP expectations, ensuring traceability, documented process control, and compliant product release. Environmental management, emissions control, and sustainable EO processing are implemented in line with evolving regulatory expectations, including current FDA guidance on sterilization sustainability and emissions reduction.
Routine Sterilization as a Controlled Industrial Process
During industrialization, sterilization is performed under defined routine operating parameters that reflect real production conditions rather than development assumptions.
Most of these parameters are established during sterilization validation, including:
- Load configuration and worst-case definition
- Packaging systems and material compatibility
- Exposure conditions and acceptance criteria
- Aeration or drying requirements
- Release strategy and documentation structure
Routine processing therefore represents the operational continuation of the validated state, ensuring that commercial prodution remains aligned with the validated sterilization envelope.
Medistri delivers this routine execution across:
- Switzerland – supporting high-compliance production, EU/US regulatory alignment, and complex product portfolios
- Hungary – enabling scalable industrial throughput, redundancy, and European supply-chain resilience
Together, these sites provide a dual-location sterilization infrastructure designed for reliability and continuity of supply.
Integration of Laboratory Services into Routine Operations
Routine sterilization cannot be separated from analytical verification and monitoring.
Medistri integrates laboratory services directly into the routine sterilization workflow, including:
- Bioburden and sterility testing
- Endotoxin (LAL) analysis
- Residual EO and material compatibility testing
- Sterility Testing
With Medistri, this single-provider model reduces transfer risk, shortens investigation timelines, and ensures data continuity between validation and routine production.
Post-Sterilization Handling and Release Readiness
Post-sterilization steps are executed according to the validated process
definition and sterilization technology:
Steam Sterilization
- Preparation for secure transport and logistics integration.
Ethylene Oxide (EO) Sterilization
- Controlled active degassing and aeration
- Residual reduction aligned with ISO and regulatory limits
These steps ensure that products exit sterilization in a state suitable for validation confirmation, regulatory release, and downstream distribution.
Sustainable Sterilization and Regulatory Alignment
Routine EO sterilization is increasingly evaluated through a sustainability and emissions lens, particularly under evolving FDA environmental expectations.
Medistri supports sustainable cycle strategies, including:
- Mixed-load and single-load EO cycles
- Advanced gas treatment systems
- Annual CO₂ and emissions reporting per pallet, enabling: Environmental impact visibility, Product-level sustainability metrics, ESG and regulatory reporting support
This allows quality and regulatory teams to integrate environmental performance into routine sterilization governance.
Digital Traceability and Operational Transparency
Routine industrial sterilization requires continuous visibility and coordination.
Medistri provides this through MyMedistri, a digital platform enabling:
- Live order and cycle tracking
- Quality Documentation access and traceability
- Synchronization with logistics partners
- Predictable shipment coordination
This ensures real-time operational control for quality, supply-chain, and regulatory stakeholders.
Customer Success Governance for Routine Production
At Medistri, Each routine sterilization program is supported by a dedicated Customer Success Specialist, ensuring:
- Single point of contact for all routine operations.
- Continuity between validation and routine production
- Rapid deviation management
- Coordinated laboratory, logistics, and documentation workflows
- Structured communication with quality and regulatory teams
This role acts as an operational extension of the manufacturer’s quality organization.
Lead Times Supporting Industrial Planning
Defined lead-time tiers support production scheduling and inventory strategy:
- SuperExpress: 2–5 days
- Express: 5–7 days
- Standard: 7–14 days
These options allow manufacturers to balance speed, volume, and cost within validated routine operations.
Routine Sterilization as a Foundation of Industrial Readiness
Routine sterilization during industrialization is more than repeated cycle execution. It is the operational realization of the validated sterilization strategy, supported by:
- Dual-site European infrastructure (Switzerland & Hungary)
- Integrated laboratory verification
- Sustainable EO cycle design and emissions transparency
- Digital traceability via MyMedistri
- Dedicated customer success governance
- Predictable industrial lead times
Together, these elements ensure that sterilization becomes a stable, compliant, and scalable pillar of commercial medical device and pharmaceutical manufacturing.
To learn more about Medistri’s Routine Sterilization Service, please visit our website here or contact us at contact@medistri.com.
– The Medistri Team
#Medistri
About Medistri
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 industrialization.
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 back-end processes.
Our synchronized departments work together to provide a complete stack of services:
- Contract Sterilization & 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.
Medistri Solutions for Product in Industrialization Phase
In the industrialization phase, reliability, scalability, and operational excellence become paramount to sustain high-volume production, maintain consistent quality, and ensure uninterrupted supply to the market.
Medistri serves as your long-term, fully integrated infrastructure partner, delivering a robust portfolio of in-house services optimized for routine commercial manufacturing and ongoing compliance.
Our solutions include routine sterilization services, validation review and maintenance, issuance of sterilization CO₂ certificates, routine laboratory services, environmental monitoring, kit packing services, post-sterilization storage, picking, packing, and shipping, as well as dedicated audit support services.
By controlling the entire production and quality assurance chain within our facilities, Medistri eliminates external dependencies, guarantees process consistency and full traceability, minimizes downtime risks, and supports seamless scaling.
allowing your team to focus on optimizing product performance, expanding market reach, and driving long-term commercial success with confidence.
Frequently Asked Questions
1. What is routine sterilization in the industrialization phase?
Routine sterilization is the execution of validated sterilization processes under stable, repeatable production conditions during industrialization and commercial manufacturing. It ensures process consistency, regulatory compliance, predictable lead times, and full traceability, forming a controlled continuation of the sterilization validation state.
2. Which regulatory standards and quality systems govern routine sterilization?
Routine sterilization is performed within a certified regulatory framework aligned with:
- ISO 11135 (Ethylene Oxide Sterilization)
- ISO 17665 (Steam Sterilization)
- ISO 13485 quality management systems
- Applicable GMP expectations
- Evolving FDA guidance on sustainability and emissions control
Operations are executed across Medistri’s Switzerland and Hungary facilities, ensuring compliant processing and global market readiness.
3. How are laboratory testing and post-sterilization activities integrated?
Medistri integrates laboratory services directly into routine sterilization, including:
- Bioburden and sterility testing
- Endotoxin (LAL) analysis
- Residual EO and material compatibility testing
- Post-sterilization handling follows validated technology-specific requirements:
- Steam: conditioning, exposure, drying, thermal stabilization
- EO: controlled aeration, residual reduction, material-dependent degassing
This integrated model ensures data continuity, compliant release, and reduced investigation timelines.
4. How does Medistri support sustainability, traceability, and operational control?
Routine sterilization is supported by:
- Mixed-load and single-load EO sustainable cycle strategies
- Advanced gas treatment and emissions abatement systems
- Annual CO₂ and emissions reporting per pallet and product
- MyMedistri digital platform providing: Live order and cycle tracking, Quality documentation access, Logistics synchronization and shipment visibility
Each program is managed by a dedicated Customer Success Specialist, acting as an extension of the manufacturer’s quality organization.
5. What lead times and infrastructure support industrial production?
Medistri provides dual-site European sterilization capacity in Switzerland and Hungary, enabling scalability and supply-chain resilience, with defined routine lead times:
- SuperExpress: 2–5 days
- Express: 5–7 days
- Standard: 7–14 days
Together with integrated laboratories, sustainability controls, digital traceability, and regulatory compliance, routine sterilization becomes a stable and scalable foundation for commercial medical device and pharmaceutical manufacturing.