Name: Bacterial Retention Testing - Validating Sterilizing Grade Filters
Uploaded: 2026-09-18T14:05:25.197Z
Description: Video explains bacterial retention test set-up. Including a scale-down model to validate critical parameters under worst-case scenarios, managing risk and contributing to safe pharmaceutical drug production.

<h2>Bacterial retention filter validation testing for safe pharmaceutical drug production</h2>
<p>Ensure your filtration systems deliver sterile effluent under challenging conditions. Our bacterial retention testing uses a scale-down model to validate critical parameters under worst-case scenarios, managing risk and contributing to safe pharmaceutical drug production. Contact us to design and validate your filtration systems aligned with PDA Technical Report 26 and global regulatory standards.</p>


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<h2>Validate sterilizing-grade filters under worst-case conditions</h2>
<ul>
<li>Challenge sterilizing-grade membranes under worst-case conditions to validate retention of ≥10⁷ bacteria/cm², ensuring reliable outcomes.</li>
<li>Follow PDA and ASTM standards, using Brevundimonas diminuta or alternative strains justified by bioburden data.</li>
<li>Test one drug product lot with three sterilizing-grade membrane lots, including size controls and viability/recovery studies.</li>
<li>Simulate your drug product process conditions to provide empirical evidence to validate your sterile filtration.&nbsp;</li>
</ul>


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Bacterial retention testing validates filter performance, ensuring biopharmaceutical processing quality under worst-case conditions for regulatory compliance.

/content/dam/cms-commons/sigmaaldrich/marketing/global/videos/services/product-services/bacterial-retention-testing-mk.mp4

Video explains bacterial retention test set-up. Including a scale-down model to validate critical parameters under worst-case scenarios, managing risk and contributing to safe pharmaceutical drug production. 

Bacterial Retention Testing

Bacterial retention filter validation testing for safe pharmaceutical drug production

Validate sterilizing-grade filters under worst-case conditions

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