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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.

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.

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. 

Developing innovative medical device technology is a high-risk operation.

That’s why start-up ventures to large established medical devices manufacturers use Medistri’s laboratory testing services to deliver accurate and reliable results for all their testing needs.

PDMS analysis by FTIR is a test that consists of extracting and identifying PDMS residues in a qualitative/semi-quantitative method in pharmaceuticals or medical samples.

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 is defined as “The ability of a device material to perform with an appropriate host response in a specific situation”.

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.

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.