Medistri SA

Medistri's Swiss Laboratory, located in Domdidier, operates as an ISO/IEC 17025 accredited analytical and microbiological testing laboratory supporting medical device, pharmaceutical, biotechnology, and sterile packaging manufacturers serving EU and US markets.

The laboratory functions within Medistri's harmonised dual-site infrastructure — Switzerland and Hungary — while maintaining technical competence and impartiality in accordance with ISO/IEC 17025 requirements.

Laboratory services are structurally integrated with in-house sterilisation (EO and steam), packaging validation, qualification engineering, and controlled logistics, enabling end-to-end support from early development through commercial-scale industrial production.

All laboratory testing activities are performed within a documented quality framework compliant with ISO/IEC 17025.
In-house sterilisation activities (EO and steam) are performed under an ISO 13485:2016 certified Quality Management System and aligned with applicable international standards including:

ISO 11135 (EO sterilisation)
ISO 17665 (steam sterilisation)
ISO 10993 series
ISO 11607 (packaging validation)
GMP requirements
Relevant FDA regulatory expectations

Medistri operates sterilisation and laboratory infrastructure in both Switzerland and Hungary under a harmonised quality system, providing operational redundancy, capacity balancing, risk mitigation, continuity during industrial scale-up, and harmonised validation documentation across both sites.

Our Laboratory
The Swiss facility is Medistri's primary centre for laboratory analysis, sterilisation process development, packaging validation, and qualification engineering.

The 356 m² laboratory operates within an ISO 7 cleanroom environment and is available 365 days per year.

356 m² laboratory facility with ISO 7 cleanroom classification
ISO/IEC 17025 accredited testing laboratory
Integrated microbiology, chemistry, packaging integrity, and environmental monitoring laboratories
In-house EO sterilisation (ISO 11135) and steam sterilisation (ISO 17665) performed under ISO 13485
Primary site for IQ/OQ/PQ protocol development, execution, and regulatory submission documentation

Our Laboratory Services

Medistri's Swiss laboratory is organised to deliver coordinated testing solutions across microbiology, chemistry, material analysis, packaging integrity, cleaning validation, and environmental monitoring.

These capabilities function as part of an integrated compliance ecosystem directly connected to in-house sterilisation, packaging qualification, and logistics infrastructure.

Microbiology & Sterility Assurance
The microbiology unit supports sterilisation validation, routine batch release, and environmental control programmes.

All testing is performed under ISO/IEC 17025 technical competence.

Sterility testing
Bioburden determination and quantitative enumeration
Bacterial endotoxin testing (BET) — LAL methods
Biological indicator population verification
Microbial identification
Antimicrobial effectiveness testing

Chemical & Residual Analysis

The chemistry unit performs analytical characterisation of materials and sterilisation-related residues relevant to patient safety and regulatory compliance.

EO, Ethylene Chlorohydrin (ECH), and Ethylene Glycol (EG) quantification
VOC / SVOC / NVOC analysis
Total Organic Carbon (TOC)
Phthalates and Bisphenol screening
Hydrocarbon analysis
Heavy metals analysis (via qualified partner laboratories)
Extractables and leachables (E&L) assessment support

Sterile Barrier Integrity & Packaging Validation

Medistri provides sterile barrier integrity testing and packaging validation in accordance with ISO 11607-1 and ISO 11607-2.

Seal strength testing
Peel-open
Burst testing
Bubble emission testing
Dye penetration testing
Accelerated and real-time ageing studies

Cleaning & Reprocessing Validation

For reusable medical devices and reprocessed components, Medistri performs structured validation of manual and automated cleaning and disinfection procedures. These programmes support manufacturers and healthcare providers in demonstrating reproducible contaminant removal and compliance with hygiene and regulatory standards for reusable medical devices.

• Validation of manual and automated cleaning and disinfection processes

• Assessment of critical parameters — time, temperature, detergent concentration, mechanical action

• Haemoglobin quantification (residual blood detection)

• Total protein quantification

• Residual contaminant verification

Environmental Monitoring & Controlled Environment Testing
Environmental monitoring programmes are aligned with ISO 14644, 14698, EN 17141 and GMP classification requirements and occupational exposure standards.

Non-viable particle sampling
Microbiological surface sampling
Microbiological air sampling
Personnel monitoring
EO and VOC air sampling

Lifecycle Support Across Development Phases
Medistri's laboratory capabilities are structured to support manufacturers across all product lifecycle stages. The service model is designed to accommodate the distinct regulatory, technical, and documentation requirements associated with pre-clinical development, go-to-market regulatory submission, and commercial-scale industrialisation.

Pre-Clinical & Development Phase
During pre-clinical development, Medistri provides early feasibility testing and exploratory analytical work to establish baseline data for sterilisation process selection, packaging format compatibility, and biocompatibility risk assessment. Services at this stage are structured to generate traceable data sets that support early regulatory strategy and carry forward into formal validation programmes without rework.

• Feasibility sterilisation studies and early bioburden mapping to inform process selection

• Material compatibility assessment and preliminary packaging integrity evaluation

• Extractables and leachables support for biocompatibility risk assessment — ISO 10993 framework

• Regulatory strategy alignment for MDR, IVDR, 510(k), and PMA submission pathways

Go-to-Market & Regulatory Submission Phase
For products approaching design freeze and regulatory submission, Medistri provides fully documented validation services generating data packages compliant with EU Notified Body and FDA submission requirements. Laboratory data generated during this phase contributes directly to technical documentation, CE marking files, FDA 510(k) submissions, and PMA dossiers.

• Full sterilisation process validation — EO per ISO 11135; steam per ISO 17665

• EO residual compliance testing per ISO 10993-7

• Sterile barrier system validation per ISO 11607-1 and ISO 11607-2

• Accelerated and real-time ageing studies for shelf-life substantiation — ASTM F1980

• Biocompatibility testing support within the ISO 10993 biological evaluation framework

• Complete regulatory data packages — validation reports, traceability matrices, audit-ready documentation

Industrialisation & Commercial Production Phase
At commercial scale, Medistri provides ongoing testing and revalidation services to sustain product quality and regulatory compliance throughout the product lifecycle. With sterilisation and laboratory services co-located within the Medistri ecosystem, manufacturers benefit from predictable turnaround times and controlled industrial-scale execution integrated with client QMS change control procedures.

• Routine bioburden and sterility batch release testing

• Environmental monitoring programmes aligned with ISO 14644

• Ongoing EO and other residual monitoring

• Change control impact assessments — sterilisation and packaging process changes

• Continuous verification of sterilisation processes and periodic revalidation

Regulatory Compliance Framework
All laboratory services provided by Medistri are delivered within a documented Quality Management System aligned with ISO 13485:2016 and structured to meet the requirements of applicable EU and US regulatory frameworks. The QMS encompasses document control, change management, CAPA, internal audit, supplier qualification, and personnel training, and is subject to regular surveillance by accredited Notified Bodies. Medistri's facilities and laboratory practices are designed to support client regulatory submissions to EU Notified Bodies and the US Food and Drug Administration (FDA). All laboratory activities are performed with attention to data integrity principles (ALCOA+), traceability to reference standards, and documentation structured to withstand regulatory scrutiny at audit and submission review.

About Medistri
Medistri is Europe's leading independent contract sterilization 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.