USP <87>,<88> VI & ISO10993
Characterization of our raw materials and/or final masterbatches and compounds through careful selection, pre-testing and evaluation gives customers a clear picture of their material of choice.
Ingredients for specific masterbatches and compounds have been evaluated and characterized under ISO10993 parts 5, 10, 11, 18 and / or United States Pharmacopeia (USP) parts 87,88 (Biological Reactivity tests for Class VI devices). More details and test certificates are available on request. You can download the Clariant Evaluation Protocol at the bottom of the page.
However, because of the wide variety of medical device applications, sterilization regimes, etc, it is the responsibility of the device manufacturer to perform further appropriate tests for compliance with all requirements for the intended end-use application.
Specifically for MEVOPUR and REMAFIN-EP grades targeted at pharmaceutical packaging applications we also offer in addition regulatory declarations used in this sector namely USP <661.1> and European Pharmacopeia monograph 3.1 based on real test data.
To help reduce development time, Clariant has developed a ‘USP / ISO Range of Standard Colors’ based on pre-tested ingredients. This avoids development time and costs of matching special colors, and the possibility of additional regulatory evaluation. Also this standard range is covered by our Change Control commitment and Risk Assessment processes.
Currently these are available in polyolefin, polyester copolymer (Tritan™) PEBA (polyether block amide elastomer), polycarbonate carriers, and will be expanded to other polymer groups and a range of additives.
Newly added is the MEVOPUR-LQ range of liquid carriers combining the expertise of Clariant’s HiFormer® liquid-vehicle technology with translucent packaging (eg. PET amber) and now Liquid Silicone Rubbers (LSR) .
For more information, please download a color chart at the bottom of the page.
To assist in FDA submissions for devices and pharmaceutical packaging, such as PMA or 510(k) Clariant is including this standard range in a MAF Type III reference MAF-1833 covering the 3 designated ISO13485 sites. For a copy of Clariant MAF please refer to the links at the bottom of the page.
As part of ISO13485 quality standard, Clariant has a risk assessment process, and a clear medical policy. To read more about our medical policy please refer to the following tab.