The theme of this year’s Kilmer Conference was “Continuity: Fostering Our Future” which is linked to the conversations we have in previous Kilmer Conference from 2016 to 2019 “End-to-End (E2E) Microbiological Quality and Sterility Assurance”.
Laboratory
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.
Laboratory
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.
Sterilisation
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.
Laboratory
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.
Sterilisation
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.
Sterilisation
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.
Laboratory
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.
Medistri gets ahead with new renewable energy solutions for its sterilization and laboratory facilities.
Medistri announces in 2022 that 100% of its sterilisation & laboratory facilities are moving to 100% renewable electricity.
