What are Endotoxins?

Endotoxins, also known as lipopolysaccharides (LPS), are components of the cell walls of Gram-negative bacteria. They can trigger severe immune responses in humans, leading to fever, shock, and even death if present in pharmaceuticals and medical devices.

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Testing Methods

At Tentamus Pharma UK, we apply validated methods such as the LAL Assay (Limulus Amebocyte Lysate Assay) for the detection and quantification of endotoxins. This method utilises the clotting reaction of horseshoe crab blood in the presence of endotoxins, ensuring accurate and reliable results.

Scope of Testing

Bacterial Endotoxin Testing is performed on various stages of pharmaceutical products including:

  • Raw Materials: Ensuring the safety of the ingredients used in production.
  • In-Process Samples: Monitoring contamination during the manufacturing process.
  • Finished Products: Verifying the final product before it reaches the market.

This testing is especially critical for products intended for injection, implantation, or infusion.

Regulatory Compliance

In the UK, the European Pharmacopoeia (Ph. Eur.) mandates strict limits on endotoxin levels in pharmaceutical products. By adhering to these regulations, pharmaceutical companies can ensure compliance, reduce the risk of adverse reactions, and maintain the highest standards of product quality and safety.

Benefits of Bacterial Endotoxin Testing

  • Regulatory Compliance: Ensures products meet the stringent requirements set by regulatory bodies.
  • Patient Safety: Reduces the risk of severe immune responses caused by endotoxins.
  • Product Quality: Maintains the integrity and efficacy of pharmaceutical products.
  • Contamination Control: Helps identify and address potential sources of endotoxin contamination throughout the manufacturing process.

By conducting thorough Bacterial Endotoxin Testing, Tentamus Pharma UK supports pharmaceutical companies in delivering safe, effective, and high-quality products to the market.

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