iNet Login|
United States
Pharma & Biopharma Manufacturing & Testing Services
Contact Us 1.800.756.5658


Contact Us


Toll Free 1.800.756.5658

US - Local 1.301.738.1000


Request Information

General Inquiries

Bioburden Testing

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.

Apps, Tools, Newsletters & More...
  Find the latest scientific resources from Sigma-Aldrich.

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