GC/MS Analysis

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.

GC/MS Analysis are recognised for being one of the most highly reliable and effective analysis for the pharmaceutical, Biotechnology & Medical Device industries.

GC/MS Analysis are also preferable for chemical compounds with low limits of detection. Our customers use our GC/MS Analysis to analysis sample in any size chemical state particularly when sample quantity is restricted.

Medistri’s Laboratory leverages world-class equipments and infrastructure to maintain the highest level of accuracy and precision for our customers most specific applications.

GC/MS Analysis can identify both volatile and semi-volatile chemical compounds. Medistri’s laboratory can analyse both liquid and gas compounds using the direct injection method into gas chromatography - allowing for a large scope of applications:

• VOC & SVOC Testing.
• Residual Analysis.
• Compound Separations.
• Compliance.
• Identification and Quantification.
• Material Outgassing Testing.
• Identification of Debris & Contamination.
• Identification Impurities.
• Identification of Potential Extractables and Leachables.

Our laboratory works according to ISO 17025 (current version) and is accredited since 2008 by the Swiss Accreditation Service (SAS). All testing can be performed according to European or US pharmacopeias.

Volatile Organic Compounds (VOCs) Analysis by GC/MS

Volatile organic compounds (also known as VOCs) are compounds that evaporate rapidly from their liquid or solid state into the atmosphere under normal pressure and temperature conditions. VOCs are of concern due to their low boiling points, extensive use, relatively high toxicity, and a high degree of halogenation.

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.

However, this procedure requires rigorous quality control. Therefore, the GC/MS system must be conditioned and prepared before starting the analysis. Volatile Organic Compounds (VOCs) are collected by incubation of the device at 150°C in a sealed vessel using Head-Space Trap Technology and analyzed by gas chromatography-mass spectrometry (GC/MS) which will provide a signal and a identification using NIST ( NIST: National Institute of Standards and Technology) database.

PDMS Analysis by FTIR

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.

Polydimethylsiloxane, commonly called PDMS or dimethicone, belongs to a group of polymeric organosilicon compounds (large molecules formed by the linking of monomers) commonly called silicones. This compound, thanks to its inert and non-toxic components, is frequently used in the pharmaceutical/medical industries.

PDMS is optically transparent and, in general, inert, non-toxic and non-flammable - it is one of many types of silicone oil.
According to ISO 7886-1, sterile, single-use hypodermic syringes used for medical purposes must not exceed a certain concentration of this type of compound, i.e. 0.025mg/cm2.

The analysis consists of using a predefined "pool" of syringes in which dichloromethane (which acts as an extractant) is added to dissolve the silicone. Once the silicone is dissolved, and the extractant evaporated, we will use the "FTIR" equipment to identify the extract by comparing its spectrum with a database.