Resins and Medical Devices

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)

• Enzyme-based glucose sensors.

Medical devices are required to be compliant with ISO 10993-17:2002, which describes methods and limitations for extractable, leachable and toxicological limits for substances which may leach from the medical device. Polymers used as part of medical devices need to demonstrate their safety and compliance as part of the device to the ISO 10993- 17:2002. This is assured by controlling and defining levels of leachables/extractables, which vary depending on dosage and repetition of use.

Regulatory Information

All Purolite Healthcare & Life Sciences products produced in our ISO-certified production facilities in the UK, Romania, China and the USA. 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.