Medistri's FAQ
Medistri offers comprehensive sterilization solutions:
- Ethylene Oxide (EtO) Sterilization
- Steam Sterilization (Autoclave)
- Sterilization Validation Services
Our experts guide you in selecting the most appropriate method based on your product’s materials, geometry, and regulatory requirements.
- EtO Sterilization: Includes full validation, traceability, and is compliant with ISO 11135. Suitable for commercial release.
- EtO Treatment: For non-validated products. Includes a Certificate of Treatment
- EtO: 11–15 hours plus aeration (duration varies by product type).
- Steam: 1–3 hours, depending on load type and packaging.
- Super-Express: 2–5 business days
- Express: 5–7 business days
- Standard: 7–14 business days
Urgent or custom lead times can be arranged.
- EtO Chamber (Switzerland): 16 EURO pallets or 14 US pallets (max height: 2400 mm)
- Steam Autoclave: Max load dimensions L30 × W60 × H30 cm; volume 400L
- Heat-sensitive devices
- Pre-filled syringes, vials, cartridges
- Implants, surgical kits, catheters
- Multi-layer packaging, electronics
- Glass vials
- Metal instruments
- Stainless steel trays
- Certain pharmaceutical components (heat-resistant)
EO: Not suitable for liquids; residual gas must be aerated
Steam: Not suitable for heat-sensitive materials; may damage adhesives or polymers
Yes. We handle full-cycle validation including:
- Protocol creation (IQ, OQ, PQ)
- Sample processing
- Testing & analysis
- Final validation reports (ISO 11135 or ISO 17665) Standard timeline: 8–12 weeks
- Certificate of Sterilization (EtO or Steam, additional cycle data can be issued per request)
- Certificate of Treatment
- Batch Release Summary
- Laboratory Reports
All documents are securely issued via MyMedistri.
Within 2–3 business days after process completion.
What is included in the certificate?
- Product & batch ID
- Process date and method
- Sterilization cycle parameters
- QA release signature
- Traceability data
We offer:
- Bioburden & Sterility Testing
- Endotoxin (LAL) Testing
- Residual Gas Analysis
- Stability Studies
- Environmental Monitoring
- Cleanroom Validation
- Packaging Integrity Testing
Available to all life sciences clients, including:
- Medical device manufacturers
- Pharmaceutical companies
- Biotech startups
- CMOs and CDMOs
Medistri SA – Laboratory Division
Route de l’Industrie 96
CH-1564 Domdidier, Switzerland
Samples must be sealed, labeled, and securely packaged.
Yes. We offer:
- Method development
- Method validation per Ph. Eur., USP, ISO
Yes. Our lab is GMP-compliant and routinely audited by Swissmedic and international clients.
Certifications held:
- GMP Certification
- ISO/IEC 17025 Accreditation (selected tests)
Yes. On-site or virtual audits may be scheduled in advance.
- PDF certificates
- Delivered via email or uploaded to MyMedistri
- Excel/XML and other documents upon request
Yes. We assist with documentation for:
- CE Marking (EU)
- FDA 510(k) or PMA (USA)
- Clinical trial submissions
Yes. We provide:
- Custom protocol development
- Documentation for investigational batches
- Sample & data coordination
Yes. GMP-compliant pickup and delivery options are available across Europe and Switzerland.
In compliance with ISO 11607, ASTM, ISTA standards:
- Aging (Accelerated & Real-Time)
- Peel, Seal, Bubble, Dye Migration
- Burst & Compression
- Drop, Vibration, Climatic Simulation
Do you simulate transport?
- Yes. Transport simulation includes:
- Drop and rotational shock
- Pallet handling & impact vibration
- Thermal & humidity cycles
- Altitude simulation
Medistri can organize transport with:
- Swiss Post (CH)
- DHL, UPS, FedEx (International)
- GDP-compliant refrigerated or ambient options
No. Under our temporary import/export license, goods processed and returned within 3 months are duty exempt.
- Use plastic pallets
- Attach batch labels and corner protection
- For lab samples, use closed, sealed containers Contact us for a detailed shipping checklist.
Yes. Options include:
- Ambient storage (standard)
- Controlled room temperature
- Cold storage (limited capacity)
Storage is GDP-compliant and can be integrated with transport.
Yes. Pre- and post-process storage is available for planned production or dispatch delays.
Switzerland Headquarters
Route de l’Industrie 19
CH-1564 Domdidier. Switzerland
Sterilization, Laboratory, Logistics, Customer Service
Hungary Site
Sterilization-only site for EU-wide distribution
(GPS coordinates and address available upon request)
- 6 EtO chambers in Switzerland
- 1 EtO chamber in Hungary
New chambers are planned to be added.
- Admin Office: Mon–Fri, 08:00–12:00 / 13:30–17:00
- Logistics: Mon–Fri, 07:00–17:00
Yes. Must be pre-scheduled with our logistics team.
Just under 100 specialists covering:
- Microbiology & Chemistry
- Quality & Regulatory
- Engineering
- Administrative & Customer Services
- Logistics & Planning
- Technical Maintenance
Medistri was established in 2006 in Switzerland. We now serve over 500 international customers annually.
- ISO 13485: Medical Device QMS
- ISO 11135 / 11137: Sterilization standards
- ISO 14001: Environmental Management
- ISO 17025: Laboratory Accreditation (scope available)
- FDA Registered
- Swissmedic Licensed
Yes. Our sites are:
- FDA registered (USA)
- Swissmedic licensed (EU/CH)
- General Inquiries: customerservice@medistri.com
- Lab Inquiries: lab@medistri.com
- You can access your MyMedistri by clicking on the link here: https://medistri-it.slab.com/posts/faq-customer-platform-3zorn18y?shr=3zorn18y