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September 19, 2018

Protecting your DNA: ISO 18385 Forensic DNA Grade

By GE Healthcare Life Sciences

GE Healthcare Life Sciences is one of the key suppliers of forensic sample collection and storage solutions and has a reputation for providing the highest quality products.

In line with the creation of global standards which address the growing concern over potential contamination of products used in human DNA collection, storage and analysis, we have reviewed our existing manufacturing practices against ISO 18385.

Where products are tested in accordance with this standard, GE Healthcare Life Sciences has self-declared compliance to ISO 18385 for its FTA sample collection card and kit manufacturing facilities and processes.  This highlights the rigour and quality measures employed to minimize the risk of human DNA contamination.  Products tested and released in accordance with this standard can be labelled ‘ISO 18385 Forensic DNA Grade’.

FTA sample collection cards are manufactured under clean room conditions in a restricted access, ISO 8 and class 100,000 compliant facility.  All staff entering the facility wear full cleanroom protection, including shoes, gloves, facemasks and hairnets.  Kits are assembled in an automated workflow within the ISO compliant facility to further remove sources of contamination from the process.

Anonymous DNA profiles are retained, via a voluntary exclusion database, for relevant personnel involved in card and kit manufacture.

Products not suitable for post-production treatment can be released via batch testing for the absence of human DNA in alignment with Clause 9 of ISO 18385.

Continuous improvement activities ensure risk analysis of all potential sources of DNA contamination are regularly reviewed.

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