Medistri's FAQ

• 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.

All our certifications can be found following this link:

• EN : https://www.medistri.com/en/all-our-quality-certificates
• FR : https://www.medistri.com/fr/certificats-de-qualite
• DE : https://www.medistri.com/de/qualitaetszertifikate
• HU : https://www.medistri.com/hu/minden-minosegi-tanusitvanyunk

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

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.–.

BatchProtect™ is an optional contractual service available for eligible products processed through Medistri’s EO Sterilization and EO Treatment services in Switzerland and Hungary. Subject to confirmation by Medistri and the applicable contractual conditions, BatchProtect™ provides an additional layer of protection against certain direct physical loss or destruction of products occurring during eligible operations within Medistri facilities. BatchProtect™ is a contractual service and does not constitute an insurance product.

No. BatchProtect™ is entirely optional. Unless otherwise expressly agreed in a customer-specific contract, BatchProtect™ protection applies only when the service has been selected and confirmed for the relevant batch.

BatchProtect™ may be particularly relevant for:

• High-value medical devices
• Complex assemblies
• Customized products
• Products with long manufacturing lead times
• Limited or critical production batches

It is designed for situations where the replacement value of the products may be significant and where the customer wishes to add an additional contractual layer of protection.
 

When selecting BatchProtect™, the customer declares the replacement value of the goods included in the batch. The declared value should reflect the actual production or replacement cost of the products and should exclude resale price, market value, expected profit or commercial margin. The applicable BatchProtect™ conditions are then defined and confirmed by Medistri before processing.

Yes. BatchProtect™ is based on Medistri’s contractual framework, but the applicable conditions can be adapted depending on the customer, product, batch value and project requirements. Depending on the agreed arrangement, customer-specific terms may include:

• Declared batch value
• Eligible operations
• Deductible
• Maximum compensation
• Pricing
• Other specific contractual conditions

Customers should contact their dedicated Customer Success Specialist to define the appropriate BatchProtect™ solution.

BatchProtect™ pricing is defined based on the specific characteristics of the customer’s products, declared batch value, processing requirements and requested level of protection. Pricing and applicable conditions may therefore vary depending on the agreed BatchProtect™ arrangement. For a tailored proposal, please contact your dedicated Customer Success Specialist.

A deductible may apply depending on the agreed BatchProtect™ conditions. The applicable deductible is defined as part of the customer-specific arrangement and confirmed before processing.

Yes, a maximum compensation limit applies. The applicable limit is defined and confirmed as part of the agreed BatchProtect™ conditions and may vary depending on the customer, product value and requested level of protection.

Subject to confirmation by Medistri and the applicable contractual conditions, BatchProtect™ may apply to direct physical loss or destruction resulting from eligible incidents occurring within Medistri facilities, including incidents associated with:

• Sterilization or treatment operations
• Handling or loading activities
• Processing operations
• Internal logistics activities

An incident must be reviewed and confirmed by Medistri before compensation may apply.

BatchProtect™ does not cover, among other exclusions defined in the applicable contractual conditions:

• Product or packaging defects
• Regulatory or technical non-compliance
• Incorrect information, declarations or instructions provided by the customer
• Damage existing before receipt by Medistri
• Indirect or consequential losses
• Loss of profit or revenue
• Costs resulting solely from delays
• Products that can reasonably be recovered or reprocessed
• Force majeure events, unless otherwise expressly agreed
• Losses arising outside the agreed scope of BatchProtect™

The applicable contractual documentation always prevails.

Where affected products can reasonably and compliantly be recovered or reprocessed, BatchProtect™ compensation will generally not apply solely because an initial processing operation was unsuccessful. Where technically appropriate, Medistri may propose reprocessing following customer authorization.

Products, dummies, samples and packaging used for validation or test-development activities may be exposed to repeated trials or challenging process conditions. Unless expressly agreed otherwise in writing, damage resulting from the normal execution of validation or development activities is not covered.

For a confirmed eligible incident, compensation is calculated according to the agreed BatchProtect™ conditions and based on the accepted declared replacement value attributable to the affected products. Any applicable deductible, compensation limit and exclusions will be applied according to the customer-specific contractual arrangement.

Where available, BatchProtect™ can be selected through MyMedistri.
Customers declare the replacement value of the batch and review the applicable conditions before confirming the service.
For tailored requirements, customers should contact their dedicated Customer Success Specialist.

Any complaint relating to damage or visible degradation should be reported to Medistri within the period defined in the applicable contractual conditions. Notifications and supporting information should be sent to: contact@medistri.com

Customers should include the relevant order or batch reference and all available supporting documentation.

No. BatchProtect™ is an optional contractual service provided directly by Medistri. It does not constitute an insurance policy or insurance product.

This FAQ is provided for general information only. The applicable quotation, order confirmation, BatchProtect™ conditions, Medistri General Terms and Conditions and any customer-specific contractual agreement govern the service. In the event of any inconsistency, the applicable contractual documentation prevails.