Materials News

TPVs meet FDA standards

Medalist MD-200 series elastomers range from ultra-soft 15 Shore A compounds to 80 Shore A grades, and do not need pre-drying because they are non-hygroscopic and have a light natural colour that permits efficient use of colourants. All grades have been certified to pass ISO 10993-5 and are Drug Master File listed with the US Food and Drug Administration. The compounds contain none of the extractable heavy metals commonly used in the curing of thermoset rubber. Due to the lower oxygen absorption, the material is said to offer higher protection of pharmaceutical contents when used in seals or gaskets for vials.

Moreover, the elastomers can be sterilised in steam, autoclave, or gamma irradiation processes. Like all thermoplastics, they process more easily and quickly than rubber, offer greater design freedom, and are recyclable. Most grades in the series adhere well to PP in over-moulding.