Contract Sterilisation Services
Engineered for Growth.
Medistri’s sterilisation infrastructure was engineered to allow you to save time and distribute your products on the market faster. We have optimised our sterilisation processes to provide you with the fastest sterilisation services available to date.
Compliance & quality at our core.
Our team includes world-class security experts, all focused on different parameters of our cycles in order to answer your specific needs and to respect the complexities of your products to be sterilised.
Medistri meets our industry’s certification standards and adopted the highest standards of quality assurance.
Sterilisation Technologies
EO Sterilisation
Ethylene Oxide (EO or ETO) sterilisation technology is used for the sterilisation of more than 62% of single use pharmaceutical and medical devices. The process requires the simultaneous control of five variables: product design, gas concentration, temperature, relative humidity, and time of exposure. As a low-temperature sterilisation technology (generally between 40-60°C), it is used particularly for heat-sensible products.
Medistri’s smarter & intelligently designed EO sterilisation cycles can be completed within 4 days from the arrival of your products at our facilities.
Steam sterilisation
Steam sterilisation is a widely used non-toxic sterilisation technology that works by exposing your products to pressurised steam at high temperatures in order to destroy viable microorganisms. Medistri's Steam Sterilisation Infrastructure is fully certified for Medical Device Sterilisation & Pharmaceutical Sterilisation.
Our team focuses on designing custom cycles after studying all the critical parameters of your products to deliver high sterility assurance levels without influencing the pharmaceutical validity of the products.
Sterilisation for Pharmaceutical Vials
A crucial prerequisite of terminal sterilisation is to improve the aseptic manufacturing sterility assurance standard of pharmaceuticals without impacting pharmaceutical validity. Medistri is a global leader in industrial pharmaceutical vial sterilisation. Our infrastructure allows you to sterilise your pharmaceutical vials at industrial scale 24/7 while ensuring the integrity and durability of your products. Medistri is certified GMP compliant by Swissmedic.
A fully integrated stack of services.
Medistri is continually innovating our in-house range of services. We’re expanding our services to offer a complete integrated suite of solutions for the innovative healthcare companies. Organisations of every size — from startups to large enterprises use our suit of services to grow & optimise their business.
Medistri combines all its technical infrastructure together and places quality at the heart of our day-to-day operations. Allowing you to simplify your supply chain management and focus on growth.
Discover how our customers use Medistri's stack of integrated services
EO Sterilisation
We’ve invested our resources in order to offer a sustainable alternative to the traditional EO sterilisation process. Medistri has introduced a smarter alternative to the market called the “Biological Indicator/ Bioburden Approach”. This approach requires that the Bioburden stays constant over time and less resistant than the biological indicators used.
- Shorter Cycle Duration.
- Reduces Gas Use.
- Sustainable & Environmentally Friendly.
Application Areas
- Pharmaceutical vials.
- Temperature-sensitive products.
- Products with integrated electronics.
- Products with integrated batteries.
- Polymer-based products.
- Implants.
- Surgical Kits.
- Single-use medical devices.
- Drug-Device Combination products.
Key Benefits
- Sterilise Temperature-Sensitive products.
- Sterilise a wide range of products & materials.
- Allows for multiple packaging variations.
- Release your product directly after processing.
- Scalable solution for high growth companies.
- Fast.
Steam sterilisation
Steam sterilisation technology exposes your products with saturated steam under pressure. Steam enhances the ability of heat to kill microorganisms by reducing the time and temperature required to denature or coagulate proteins in the microorganisms. Steam sterilisation cycles generally have three phases including conditioning, exposure and exhaust.
- Between 110-134°C
- Qualified for volumes as large as 400L.
- Fully customisable cycles.
Application area
- Metallic Surgical Instruments.
- Ceramic based products.
- Glass based products.
- Liquids in open or closed containers.
- Gels in open or closed containers.
- Filled Syringes.
- Pharmaceutical Vials.
- Porous Fabrics.
Sterilisation Validation Services
The objective of sterilisation validation is to determine that the sterilisation process will consistently achieve sterility and that it won’t have an undesirable effect on the device, packaging or patient health.
Our in-house experts will work closely with your team. Throughout all the multiple phases of the process to create a report as part of your final sterilisation validation process. The validation report details the process analysis as well as the test results for your validation process. This ensures complete traceability, transparency at each stage of the project. Our experts aggregate all data, outline findings and make proposals in a transparent, detailed and precise manner.
Medistri's accredited laboratory carries out all necessary testing in-house to develop new cycles corresponding to your product complexities.
- Ethylene Oxide validations are carried out in accordance with ISO11135
- Steam Sterilisation validations are carried out in accordance with ISO17665
Are you ready to get started?
Contact us and our qualified team will respond.