Medistri's FAQ

Medistri offers comprehensive sterilization solutions:

  • Ethylene Oxide (EtO) Sterilization
  • Steam Sterilization (Autoclave)

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 & Hungary): 16 EURO pallets or 14 US pallets (max height: 2400 mm)
  • Steam Autoclave (Switzerland): 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:
    • EtO: 8 to 12 weeks;
    • Steam: 3 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
  • And others

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, securely packaged, and a transport delivery note must be included.

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
  • International registrations

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 96

CH-1564 Domdidier, Switzerland

Sterilization, Laboratory, Logistics, Customer Service

 

Hungary Site

Sterilization, logistics site for EU-wide distribution

Medistri HU

Kamilla utca 18.

8000 Székesfehérvár

Hungary

  • 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.

Yes. Our sites are:

  • FDA registered (USA)
  • Swissmedic licensed (EU/CH)

The status of your order can be observed in your MyMedistri account. All updates and tracking details are available on your account.

Our operations are active 24/7 and the company remains open at all times. However, our administrative offices are closed on the following public holidays:

  • Jan 1, Apr 18, May 29, Jun 19, Aug 1, Aug 15, Nov 1, Dec 8, and Dec 25.

For a quote tailored to your project, please contact our customer service team at customerservice@medistri.com

Yes, Medistri requires a minimum purchase order of CHF 250.–.