(Download: Bacterial Endotoxins Validation in PDF by Medistri)
Bacterial Endotoxins Validation is a critical process in the pharmaceutical industry that ensures the safety and quality of products. Endotoxins from gram-negative bacteria are the most common cause of toxic reactions resulting from contamination of pharmaceutical products.
Bacterial Endotoxins Validation checks the sensitivity of the lysate in the presence of the product to ensure that it does not differ significantly from its sensitivity in the absence of it. In other words, the proposed product does not present interference factors which may result in false negatives or false positives, this taking into account the maximum dilution at which samples can be determined.
The objective of the validation protocol is to establish documented evidence that the process employed for Bacterial Endotoxin Testing (BET) will consistently produce the desired results. This protocol is applicable to products which require endotoxin testing.
The validation process involves checking the sensitivity of the lysate (a substance derived from blood cells of horseshoe crabs) in the presence of the product to ensure that it does not differ significantly from its sensitivity in the absence of it. In other words, the product does not present interference factors which may result in false negatives or false positives.
The method used in STS 504 is kinetic colorimetry. In this method, samples are mixed with the lysate reagent in a 96 well plate, and a plate reader measures the color change over time. The liquid in the wells becomes more yellow over time, and the rate of that color change is proportional to the amount of endotoxin present in the sample.
STS 504 is an accreditation for endotoxin analysis, both in routine tests and validation. The tests are performed according to the European Pharmacopoeia and the harmonized text of the current pharmacopoeia (European, American, and Japanese).
Medistri's in-house laboratory is a full-service contract laboratory, specialised in microbiology, analytical, bioanalytical chemistry & cell biology services, custom synthesis, and R&D.
🎯 To learn more about Medistri’s Bacterial Endotoxins Validation, visit on our website here or directly contact our team at contact@medistri.swiss.
- The Medistri Team
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