Bioburden testing is a regulatory requirement for investigational new drug submissions and is critical for process development of biologics and medical devices. It can provide an accurate basis for calculating effective sterilisation doses for a given therapeutic and will provide the quantity of viable microorganisms in or on a therapeutic, medical device or raw material before sterilisation.
Bioburden testing is applicable for:
- Bulk Lot Release Testing
- Final Product Release Testing
- Raw Material Testing
- Medical Devices
Contact an expert about your bioburden testing needs.
Copyright © 2017 Sigma-Aldrich Co. LLC. All Rights Reserved. Reproduction of any materials from the site is strictly forbidden without permission. Sigma-Aldrich brand products are sold exclusively through Sigma-Aldrich Co. LLC. Sigma-Aldrich Corp. is a subsidiary of Merck KGaA, Darmstadt, Germany Terms | Privacy