29 May 2020

FKM in medical sector

Generally, a variety of polymers are used for applications in the medical sector, included fewer valuable elastomers. However, when repeated sanitizing cycles, steaming, high pressure, high temperature or vacuum are used, fluorinated polymers guarantee a reliable and enduring efficiency.

Thanks to FKM and FFKM high purity, contamination is absent or minimal when working in contact with fluids.

Current certification compliance is a compulsory requisite: the most common certifications are FDA 21 CFR177.2600 for FKM and FDA 21 CFR.2400 for FFKM, both American, but adopted in 140 countries worldwide.

Raw materials approved by the suppliers through the American NSF agency are already available:in this instance validation is simple.

In addition to FDA certifications, 3-A Sanitary Standard class may be also required. All the mentioned standards were originally for food applications. However nowadays they represent the best practices for sanitary appliances manufacturing worldwide.Therefore, for many applications the above-mentioned certifications may be enough.

The next step is the biocompatibility requirement. For this purpose, the most common certifications are the USP reference standard released by the distinguished American Pharmacopeia.

If the moulded part will be in contact with the human body, USP class VI certification compliance is required. In theory all FKM polymers can be validated, provided that specific tests are passed. With regard to FFKM, some grades have already been validated by the suppliers.

The tests required for the USP class VI validation are many, but their main scope is to ensure a safe response to body, skin and tissue contact. USP class VI certification is commonly required for medical pipes, fittings and disposable devices.

Another USP standard, commonly used for biocompatibility compliance is USP87, an in-vitro test, designed to test the biocompatibility of the probe in contact with a specific cellular culture in a quickly and accurate way.

If the abovementioned USP certifications are obtained, the moulded part is approved for human body contact.