Forensic-Grade Products for Human Identification: Preparing for ISO 18385 Requirements
Currently, Promega manufacturing standards for Genetic Identity products meet or exceed ENFSI, SWGDAM and BSAG guidelines for minimizing the risk of human-to-product DNA contamination. A draft new ISO standard—ISO 18385 "Minimizing the risk of DNA contamination in products used to collect and analyze biological material for forensic purposes"—is now under review by participating ISO member countries. The ISO 18385 standard is expected to provide manufacturing requirements for suppliers of forensic-grade products, and to specify acceptable methods and pass/fail criteria for DNA contamination testing.
The attached article describes current manufacturing standards for Promega Genetic Identity products and summarizes our plans to manufacture forensic-grade products in compliance with ISO 18385 once the standard is published. Promega has manufactured high-quality products for the forensic market for more than 20 years, and our Genetic Identity kits and reagents are already subject to stringent quality standards at each step in the production process. This paper provides details of how we build controls into our manufacturing processes to minimize the risk of DNA contamination and highlights our preparation for manufacturing forensic-grade products in compliance with ISO 18385 once the standard is available.