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.

  • Sterilization: A documented and qualified process performed in accordance with the applicable standards (in this case ISO 17665 and ISO 11135), including initial validation, periodic requalifications, control of critical parameters, as well as the issuance of an official sterilization certificate. Any modification made to the product must be fully documented and communicated by the client to Medistri so that any necessary updates and requirements can be implemented promptly.

  • Treatment: A one-time or exploratory operation carried out as part of projects or developments for testing purposes. It does not include validation or the issuance of a sterilization certificate, and therefore does not authorize the product to be placed on the market under a sterile designation.

  • 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.–.