At Medistri, we aim to address these issues by using a scientifically sound risk-based approach to determine the most appropriate testing methods for each device. That’s why we follow the guidelines outlined in ISO 10993–1:2018 and the FDA’s guidance document on the use of this standard, which require a structured biological evaluation plan as part of a risk management process in accordance with ISO 14971
Organic contaminants in medical devices can cause adverse reactions in patients, reduce the effectiveness of the device, or cause the device to malfunction. TOC analysis can identify and quantify these contaminants, allowing manufacturers to ensure that their medical devices meet regulatory requirements and industry standards.
For pharmaceutical manufacturers, Elemental and Trace Metal Analysis is an important step towards development, quality control, and release. Medistri’s in-house GMP laboratory works with it customers to design pharmaceutical organic and inorganic elemental analysis.
Medistri, a leading provider of contract sterilization & laboratory services for healthcare companies, is excited to announce the arrival of its fifth sterilization line this week. The new chamber will be used primarily for the sterilization of pharmaceutical & medical devices coming from multiple countries. It will be fully operational and ready to use by the beginning of 2023.
Medistri is attending Pharmapack 2023 in Paris, France from February 1 to 2, hosting a booth to cater client meetings, showcase its services and answer all questions.
Medistri will be featuring its commitment to innovative speed, uncompromising quality, and tailored sustainable solutions.
Steam sterilisation works by placing products in a steam autoclave and exposing the products to pressurised steam at high temperatures in order to destroy viable microorganisms. This allows for the creation of saturated steam which will immediately induce condensation on the surface of the product to sterilise.