Identification of pollution in a medical bag

Medical bags are made from 2 or more layers of film which are simultaneously welded and cut, by ultrasonic, high frequency or NWS (pulse / thermal) welding. These films are generally made of polyolefins (PP, etc.) or PVC / EVA for various uses: blood transfusion bags, bags of standard solutions (chloride, dextrose, glucose), hemodialysis, drainage, etc.
During the manufacturing process, which also includes the integration of connectors and pressurization to check the tightness, it can happen that pollution occurs at different levels: pockets, connectors, connection pipes etc ... The nature of these pollution is variable and depends on the manufacturing and testing process: lubricating oil (silicone, mineral, fluorinated, etc.), organic compounds resulting from the degradation of polymeric matrices, etc.

The nature of this pollution is variable and depends on the manufacturing and testing process: lubricating oil (silicone, mineral, fluorinated, etc.), organic compounds resulting from the degradation of polymer matrices, etc.

When possible, it is preferable to wash the bag with a suitable solvent for the analysis of the extract or dry extract. But sometimes this is not possible because the pollution is located on the outside or because it is not isolable correctly, or because it is not soluble in any solvent.
To overcome these cases, Polymex has developed a sampling technique by friction with a clean and inert support which makes it possible to collect, at any level of pockets or connectors, known or suspected pollution. These inert supports are then analyzed by Pyrolysis/GCMS to detect or / and quantify organic and / and polymeric pollution. The limits of quantification (LOQ) of the pollutions sought are below the ng / medical device (LOQ_analytique <0.1 µg).

Are you a manufacturer of medical bags or medical devices and want to know if they contain pollution and how much? Call on the Polymex Laboratory!

Other examples from the health sector:

Study of leachables - Identification and determination of volatile organic compounds according to ISO 10993-18 (nonionic, 100 <Mw <650..
Stydy of leachable in nasal spray

Stydy of leachable in nasal spray

The manufacture of medical bags is based on layers of films welded by high frequency ultrasound or NWS. These films often consist of..
Identification of pollution in a medical bag

Identification of pollution in a medical bag

The existence of chemical elements, which can be released by the container or the device, during exaggerated testing (= extractables), or on..
Study of extractable and leachable compounds

Study of extractable and leachable compounds

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