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Bacterial Endotoxin Testing

March 26, 2024

Should I Test for endotoxins Pre- or Post-Sterilization?

Typically, end-product testing for endotoxin is performed post-sterilization. Performing testing post-sterilization allows for the entire manufacturing process to be evaluated for potential impact on the product or endotoxin levels. Although post-sterilization testing is typically recommended, pre-sterilization testing may be performed...

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March 12, 2024

Specifications for Endotoxin levels for Single Use systems

As endotoxin contamination on a drug product can be difficult to destroy or remove, measures built into the manufacturing process can help prevent endotoxins entering the production chain.  Therefore, these single-use systems, used during production, are required to contain low...

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February 20, 2024

Specifications for Endotoxin levels for Medical Devices

Endotoxin has the potential to trigger a pyrogenic response when introduced into the body. This response is dependent on the amount of endotoxin that is present and where in the body it has been introduced. Points of contact of concern...

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February 6, 2024

What is a PPC? What is inhibition and enhancement?  

The name PPC or Positive Product Control is dropped regularly when discussing an endotoxin detection method. It is an essential part to demonstrate the validity of an endotoxin test.  The LAL assay is a biological, enzymatical assay. It is based...

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January 23, 2024

Beta glucans: false positives in the Bacterial Endotoxins Test (BET) 

Medical devices and pharmaceuticals that come into contact with blood, lymphatic or cerebrospinal fluid should be free of harmful levels of endotoxins. Endotoxins are detected using the BET or Limulus amebocyte lysate (LAL) test.   The BET uses the lysate of...

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