Endotoxin Testing

Summary

This video explains the importance of endotoxin testing, clarifying that it is not the same as a sterility test. Endotoxins are harmful bacterial components that can cause severe reactions if present in medical formulations, particularly injectables that enter the bloodstream or spinal fluid. The transcript details how endotoxins can contaminate products even when sterile, and emphasizes regulatory requirements for testing under USP standards. It also describes the Limulus Amebocyte Lysate (LAL) test, which detects endotoxins with high sensitivity, and how results are evaluated based on patient body weight and dosage. The video encourages contacting Eagle Analytical for further guidance on endotoxin testing.

Takeaways

• 😀 Endotoxin testing is not the same as sterility testing, though they are often performed together.
• 😀 The purpose of an endotoxin test is to measure pyrogens (toxic substances) in a formulation, especially important for intra-fecal formulations going into a patient's spine.
• 😀 Endotoxins can cause severe damage if not detected and measured properly, especially in injectable products and medical devices.
• 😀 Even though a sample may be sterile, it does not mean it is endotoxin-free.
• 😀 Endotoxin testing is crucial for products that come into contact with the bloodstream or spinal fluid.
• 😀 The Limulus Amebocyte Lysate (LAL) test is used to detect endotoxins, utilizing lysates from horseshoe crabs.
• 😀 The LAL test causes a coagulation reaction when endotoxins are present, which can be measured to determine endotoxin levels.
• 😀 The test is highly sensitive and can detect endotoxins at levels as low as 0.001 endotoxin units per milliliter.
• 😀 The endotoxin limit for a sample is calculated based on the average patient body weight and the maximum dosage per hour.
• 😀 According to USP guidelines, all Category 2 injectables and compounded sterile preparations must be tested for endotoxins.
• 😀 For further information on endotoxin testing, customers can reach out to Eagle Analytical via phone or their website.

Q & A

Is an endotoxin test the same as a sterility test?

No, an endotoxin test is not a sterility test. While sterility tests check for the presence of live microorganisms, endotoxin tests measure pyrogen levels, which are toxic bacterial components that can remain even in sterile products.

Why is endotoxin testing important for medical products?

Endotoxin testing is critical because bacterial endotoxins can cause severe reactions if introduced into the bloodstream or spinal fluid. Ensuring products are endotoxin-free protects human and animal health.

What are endotoxins and where do they come from?

Endotoxins are complex lipopolysaccharides released from bacterial cell walls, primarily during cell lysis. They often enter products through contaminated water used during preparation.

Does sterilization remove endotoxins from a product?

No, sterilization kills bacteria but does not remove endotoxins. Therefore, a sterile product may still contain harmful endotoxins.

Which products are required by USP to undergo endotoxin testing?

USP mandates endotoxin testing for all Category 2 injectables, compounded sterile preparations, and products that require BUD sterility testing.

What method is commonly used to detect endotoxins?

The Limulus Amebocyte Lysate (LAL) test is used, which extracts lysate from horseshoe crabs. This lysate coagulates upon contact with endotoxins, allowing detection.

How sensitive is the LAL test?

The LAL test is highly sensitive and can detect endotoxin levels as low as 0.001 EU/mL.

How is the endotoxin limit for a sample determined?

The limit is calculated based on the average patient body weight and the maximum dosage per hour, ensuring safe exposure levels.

Can you provide an example of when endotoxin testing is especially critical?

Endotoxin testing is especially critical for intra-spinal or intravenous formulations, as even small amounts of endotoxins can cause severe reactions or damage.

Where can more information about USP <85> endotoxin testing be obtained?

More information can be obtained from Eagle Analytical by calling 800-745-8916 or visiting www.eagleanalytical.com.

Why might customers confuse endotoxin testing with sterility testing?

Customers might confuse the two because both tests are performed on sterile formulations. However, endotoxin testing focuses on pyrogen levels, while sterility testing ensures no live microorganisms are present.