The Infrastructure behind millions of product
Founded in 2006, Medistri has been focused on building infrastructure for the healthcare industry. Companies of every size, from startups & university projects to Fortune 500 companies use our services to save time, scale and focus on what they do best.Medistri reduces the barriers to healthcare product development & scalability.
Development of Medical Devices Testing Stack
Patient safety is predicated on the medical device’s specific structural materials and also on a comprehension of the compounds and residuals that might be produced or recognised throughout the supply chain. Medistri’s laboratory team aggregates all data, outlines findings, and recommend risk management proposals in a transparent, detailed, and precise manne — Allowing you to bring your safe product to market quickly.
Extractables & Leachable’s (E&L) Testing for Pharmaceuticals
Extractables and leachables (E&L) studies are now a crucial component of product release. Medistri’s Laboratory provides GMP-compliant leachables method validation for use in GMP stability testing and storage programs and are able to support a variety of closure or drug delivery systems.
Sub-Visible Particle Testing
Medistri’s laboratory performs medical device particulates testing on injections, parenteral infusions and medical devices as particulate matter is produced through various sources during processing. Particulate matter in injections and parenteral infusions consists of mobile undissolved particles, other than gas bubbles, unintentionally present in the solutions.
Contract Steam Sterilization Services
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.
Ethylene Oxide Residual Analysis
Because of its broad material compatibility, ethylene oxide (EO) is frequently used to sterilize medical equipment. It’s possible for EO to leave a residue on the material being sterilized. The following are the residues that may remain following sterilisation:
- Ethylene Oxide (EO) is a possible byproduct of processing.
- Ethylene Chlorohydrin (ECH) is a potential by product of EO’s interaction with free chloride ions.
- Ethylene Glycol (EG), a byproduct that may result from the interaction of EO with water.
Ethylene Oxide (EO) Sterilization Validation
Prior to beginning routine ethylene oxide sterilisation, a product with a sterile claim needs to complete a validation process to ensure the Sterility Assurance Level claimed is met according to ISO 11135.
An Ethylene Oxide (EO) Sterilization Validation is designed to assist the manufacturer in the development of a sterilization process that delivers the appropriate sterility assurance level and ensures repeatability for each product type developed.
Medistri drives sharp increase in sterilisation of medical devices with integrated electronics during Research & Development phases.
Medistri’s Switzerland Plant in Domdidier is optimised to help innovative companies scale faster and remove friction to their development cycles. And many of the Medical Devices most complex and innovative products contain electromechanical parts.
Medistri’s Biocompatibility Testing for Medical Devices impacts healthcare companies in more than 20 countries around Europe.
The company’s laboratory provides Biocompatibility Testing for Medical Devices according to ISO 10993. Working primarily with customers across Europe in Austria, Belgium, Finland, France, Germany, Greece, Ireland, Italy, Norway, Denmark, Israel, Switzerland, Luxembourg, Croatia, the Netherlands, Portugal, Hungary, and the UK.
