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Extractables and bioprocess products
In bioprocessing, minimizing potential safety risk to patients is of highest priority. Part of that is ensuring that no harmful leachable compounds can find their way into the product from production equipment or storage materials.
Our expertise from the bioprocess industry tells us the value single-use technologies deliver. For this reason, we take extractables and leachables (E&L) very seriously. Our bioprocess products are meticulously designed to minimize the risk of leachables impacting drug safety and efficacy. We are also committed to standardize E&L testing for bioprocess products, improving safety and reducing confusion in the industry.
Here are a few ways we are contributing:
- Comprehensive extractables information on our products
- Alignment with the extractables protocol published by BioPhorum Operations Group (BPOG)
- E&L testing service for customers
Comprehensive extractables information
In our view, bioprocess technology manufacturers should be responsible for extractables testing of their components. We therefore offer extractables information for our products. By logging in to the regulatory support application, you can access relevant extractables data for use in your own risk assessments.
Alignment with the BPOG extractables protocol
We test new products in line with the BPOG extractables protocol and update past products in a staggered approach. To find out how we do this, download the white paper Single-use extractables and leachables: GE’s alignment with the BPOG protocol.