Medical Devices and Diagnostics
We supply a broad range of Chromatography and Biocatalysis resins for optimal purity and final product quality in pharmaceutical applications.
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Chromatography and biocatalysis resins are utilized in many medical devices for treatment and diagnostic applications. These devices assist patients around the world in managing ailments such as liver and kidney failure, cystic fibrosis, metabolic deficiencies, dementia, diabetes, immunodeficiencies and many more.
We have one of the widest selections of highly pure, pharmaceutical-grade resins for applications requiring either biocatalysis or chromatographic purification, separation and extraction.
Some typical end-user applications for these resins include extracorporeal blood purification (EBP) in dialysis/nanodialysis machines, purification of foodstuffs used in enteral nutrition (e.g. infant formulas) and enzyme-based glucose sensors.
Security of Supply
Ensuring reliable availability of resins is vital to customers and is of paramount importance to Purolite. As a leading supplier of resin media to the world’s most regulated industries, we recognise that Purolite’s resins are critical purification products. As such Purolite has a real-world security-of-supply system in place to support your process requirements for business continuity.
Purolite is a global leader in resin technology, and one of the world’s largest developers and manufacturers of high-quality chromatographic resins, enzyme carriers, ion exchange resins, APIs, adsorbents and specialty resins.
All Purolite Life Sciences products are of premium quality and are produced in our ISO-certified production facilities in the UK, Romania, China and the USA.
For over 35 years, Purolite has supplied specialty resin technology to industries within complex regulatory environments including biotechnology, pharmaceutical, food, fine chemical and electric power generation.
Purolite complies with required national and international regulations, as well as many voluntary specialty certifications. These include: • Part II of the EU GMP Guide • US FDA Current Good Manufacturing Practice (CGMP) regulations • US FDA CFR - Code of Federal Regulations including Title 21 • GMO/TSE/BSE free • ResAP(2004)3 • NSF/ANSI 61/WRAS standards • REACH regulations • ISO 9001:2015 quality system specifications, • ISO 14001:2015 Environmental Management System requirements • OHSAS18001:2007 • RoHS Directive 2011/65/EU • Halal and Kosher requirements
We also hold Drug Master Files with the US FDA, Japan, Canada and EU.