Cytotoxicity Testing — ISO 10993–5
Cytotoxicity testing is used to determine the toxicity of medical devices and materials. Cytotoxicity testing evaluates whether a material can affect living cells. Medical Device Manufacturers are required to show that their devices are not cytotoxic.
Biocompatibility Testing - ISO 10993
Biocompatibility is defined as “The ability of a device material to perform with an appropriate host response in a specific situation”.
Transport Simulation — ISTA 2A, Part 2 - Compression Testing
Compression risks are about the most frequent concerns that products and containers experience during the logistics chain.
Volatile Organic Compounds (VOCs) Analysis by GC/MS
ISO 10993-18 focus on chemical characterisation of medical device material within a risk management process. Part of this process is the identification, quantification of extractables and leachable compounds using gas chromatography/mass spectrometry (GC/MS) technology.
GC/MS Analysis (also called Gas Chromatography/ Mass Spectrometry) is an analytical process that utilises the capabilities of Mass Spectrometry and Gas Chromatography in order to determine the chemical compounds within a sample.
Medistri’s EO Sterilisation Validation Flow
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.
Episode 3: Behind The Growth
In this episode of Behind the Growth, Our Site Technical Director, Mr. Sylvain Vasseur, joint us to discuss his work, how long has he’s been working at Medistri and what are the things that he likes about working within a growing company.
Steam Sterilisation Services
Steam Sterilisation Technology is a simple yet very effective decontamination method. Sterilisation is achieved by exposing products to saturated steam at high temperatures (121°C to 134°C).
Bubble Leak Testing for Pharmaceutical Products
Bubble Leak testing is a method of detecting leaks in sealed packaging by visually inspecting them against changes in pressure. Bubble Leak testing is a method of detecting leaks in sealed packaging by visually inspecting them against changes in pressure.
FTIR Spectroscopy Analysis
The Fourier Transforms converts the raw data from the infrared emission into a spectrum which Medistri’s laboratory uses to study, analyse and identify the compound.