What is ISO 18385?

ISO 18385, published in February 2016, is a new ISO standard for forensic products intended to minimize the risk of human DNA contamination during the manufacture of products used to collect, store, and analyze biological material for forensic purposes.

What do forensic labs need to do to comply with this standard?

ISO 18385 is a standard for forensic manufacturers and does not require any specific action by forensic laboratories. However, you may wish to review your laboratory SOPs for references to specific product catalog numbers and determine if they need to be updated.

What actions has Promega taken to comply with ISO 18385?

We have revised quality control testing and certificates of analysis, as necessary, to ensure alignment with the standard. We treat plastics for our forensic product line, such as primary packaging materials and consumables, with ethylene oxide to mitigate the impact of possible human DNA contamination. As a result, the catalog numbers for some treated plastic consumable products have changed.

What is ethylene oxide (EO) treatment?

EO treatment is a sterilization technology used for medical devices. The treatment is very effective at destroying DNA and rendering it unamplifiable in PCR and is an effective post-production treatment method for minimizing DNA contamination on plastics.

Which plastic products are treated with ethylene oxide?

Plastic tubes and bottles used to package DNA extraction, DNA quantitation and STR amplification reagents are treated with ethylene oxide. Additionally, plastic products that are intended for use in DNA extraction are also treated with ethylene oxide.

Which products will have revised quality control testing and certificates of analysis?

We will provide a list of products that will have revised quality control testing and certificates of analysis on this web page when appropriate.

How will I know which products comply with ISO 18385?

Promega products that are manufactured in alignment with ISO 18385 will be clearly labeled with a blue forensic grade logo. They include forensic products intended for DNA extraction, DNA quantitation and STR amplification.

Forensic Grade ISO 18385
Where can I get more information?