Promega First to Achieve Third-Party Certification of Published ISO 18385 Manufacturing Standard to Minimize Risk of Human DNA Contamination in Forensic Products

Promega Corporation has become the first major forensic manufacturer to achieve third-party certification of the published ISO 18385 standard to minimize the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes. This Forensic DNA Grade certification comes following a recent onsite audit by international certification agency Bureau Veritas.

“This critical milestone is the best way for forensic laboratories to ensure that products claimed to be produced under published ISO 18385 guidelines are indeed meeting those expectations,” said Charles York, Vice President, Manufacturing Operations at Promega. “As with our ISO 9001 and 13485 certifications, this certification further exemplifies Promega’s commitment to our customers, to our business, and to all those who rely on and benefit from the use of our products.”

Promega products manufactured in alignment with the ISO 18385 standard will include a “Forensic Grade” certification logo.

The new international standard was published on February 1, 2016, to improve the quality of forensic DNA testing by minimizing the risk of human DNA contamination during the manufacturing process. Two Promega scientists were selected by the United States Technical Advisory Group to represent the U.S. on the development of ISO 18385. They worked with forensic leaders from the Arkansas State Crime Laboratory and the National Institute of Forensic Science, Australia/New Zealand. ISO 18385 is based upon the Australian Standard

ISO 18385 certification for Promega culminated significant work by numerous departments throughout the organization including R&D, Operations, Marketing and Quality Assurance/Regulatory Affairs to ensure that processes meet the new standard requirements. This includes revised quality control testing and certificates of analysis, as necessary, and also treating plastics for the forensic product line, such as primary packaging materials and consumables, with ethylene oxide.

“Promega is continually striving to not only meet and exceed the most current quality standards for our customers, but to also be a leader in the development of new and evolving guidelines that will best serve the forensic industry,” said Ron Wheeler, Senior Director of Quality Assurance and Regulatory Affairs.

Find more information about ISO 18385 and Promega efforts related to the standard here.