👉 What is PDMS analysis by IFTR?
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.
👉 What is "PDMS"?
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.
👉 What does the analysis consist of?
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.
Our laboratory has validated a method that allows us to evaluate the content of lubricant (polydimethylsiloxane) thanks to our new equipment, including a precision analytical balance with a range of measurements from 0.01 [mg] to 52 [g]. The measurement range has a reproducibility of 0.02 [mg] and linearity of ± 0.05 [mg].
👉 What are the steps of the analysis?
1) Gravimetric measurement of the quantity of lubricant contained in a syringe.
2) Evaporation of the extractant (dichloromethane)
3) Identification with the FTIR system
👉 In which industries are PDMS used?
PDMS is widely used in the development of devices for biomedical applications. But is also used in:
- Medical Device Industry
- Pharmaceutical Primary Packaging Industry
- Food Industry
- Cosmetics & Consumer Products Industries
- Biopharmaceutical Industry
🎯 To learn more about our ISO 7881 FTIR PDMS testing services, visit our website at www.medistri.swiss or contact our team directly at [email protected].
- The Medistri Team
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