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USP 85
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Quick understanding of the test
Introduction to USP 85 - Bacterial Endotoxin Test (BET)
- Gel-Clot technique
- Turbidimetric technique
- Chromogenic technique
- Bacterial Endotoxin Test is part of the quality control process for manufacturing pharmaceuticals and medical devices.
- The test provides essential data that aid in risk management and processes concerning product safety and batch release.
Passing criteria
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Abstract
USP 85 Bacterial Endotoxins Test (BET) which is commonly known as the LAL (Limulus Amebocyte Lysate) test, is an important assay for detecting endotoxins to ensure the safety of pharma products and medical equipment.
Endotoxins are part of the outer membrane of the cell wall of Gram-negative bacteria. They are released when bacteria disintegrate or during bacterial growth. Sterilization processes that usually kill bacteria might not be effective enough to deactivate endotoxins. Therefore, products must be effectively tested to ensure that they are free from any remnants of endotoxins, which might pose a risk.
Compliance and Industry Standards for USP 85 Bacterial Endotoxin Testing
Pharmaceutical manufacturers and developers of medical devices have to comply with numerous stringent standards such as USP 85, to meet high quality and safety standards. Compliance with this standard ensures that tested products do not contain endotoxins, thereby protecting patients from health risks.
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Testing also helps meet the standards set by health authorities like the U.S. Food and Drug Administration (FDA), the European Pharmacopeia (EP), and other global regulatory bodies. Not adhering to this standard can lead to extreme penalties, including product recall, imposition of fines, and serious health risks to patients.
Bacterial Endotoxin Testing is required for a wide scope of products, which includes:
- Parenteral drugs
- Biological products
- Vaccines
- Implantable medical devices
- Dialysis solutions
Guidelines for Conducting USP 85 Bacterial Endotoxin Testing
- The sensitivity of the lysate needs to be confirmed with every batch used. The labeled sensitivity, λ, has to be within the valid range (0.5λ – 2λ) usually verified by conducting tests using standard endotoxin solutions.
- A preparatory test is required to ensure that the sample does not contain any substances that will interfere with the detection of endotoxin.
- The test should be carried out at the incubation temperatures specified by the manufacturer. In the case of the gel clot method, incubation is usually done at 37 ± 1°C for 60 ± 2 minutes.
- The test’s lysate sensitivity and accuracy must be verified using standard endotoxin solutions as positive controls.
- If interference is detected, then it should be eliminated from the sample using methods such as dilution, filtration, neutralization, or heating.
Test methodology
Gel-clot technique
Photometric techniques
- Turbidimetric
This technique measures the increases in turbidity of the reaction mixture caused by endotoxins. There are two types:
Endpoint-turbidimetric assay: The endpoint of the reaction is measured; a quantitative result is obtained.
Kinetic-turbidimetric assay: The rate or time at which a certain level of turbidity is obtained is measured. - Chromogenic
The Chromogenic technique measures the color change that occurs when endotoxins react with a reagent added to LAL. It may also be carried out in two variants:
Endpoint-chromogenic assay: The color produced is measured at the end of incubation.
Kinetic-chromogenic assay: The rate of color development is monitored.
Applications and Importance of USP 85 Endotoxin Testing
Photometric techniques
Medical devices
Intravenous solutions
Surgical and procedural kits
Ophthalmic products
Transdermal patches
Dialysis equipment
Biotechnology products
Advantages of Endotoxin Testing
- Sensitivity
The test detects the lowest levels of endotoxins, which is important for product safety.
- Versatility
The test can be applied to a diverse range of product types, including liquid, solid, and devices.
- Acceptance by regulatory bodies
Results obtained by performing this test are generally accepted by most regulatory bodies worldwide. Hence, the product is acceptable in international markets.
Frequency and Timing of USP 85 Bacterial Endotoxin Testing
- In the development phase to ensure that raw materials and intermediates must be free from endotoxin contamination.
- As a final quality control check to ensure that the finished product conforms to regulatory limits for endotoxins.
- Periodic testing for the presence of endotoxins in products under ongoing production to ensure that contamination does not occur during production processes.
Conclusion: Ensuring Safety Through Endotoxin Testing
Endotoxin testing is the core of quality assurance for pharmaceutical products, biologics, and medical devices. It is designed to ensure that the product is safe for patients through rigorous testing for the presence of endotoxins. As endotoxins are known to cause serious reactions, it is a regulatory requirement and a moral obligation to test products under this standard in order to protect patient health.
Being one of the renowned testing labs for USP 85, we offer a range of testing services to guarantee optimal safety of drugs and medical devices. Our laboratories are well-equipped to ensure efficiency, accuracy and timely production of test results.
Our state-of-the-art laboratories are equipped with advanced technology to ensure accurate and reproducible results within the designated time frame.
If you are looking to ensure your products meet the rigorous standards for endotoxin testing, contact MIS today to learn more about our Bacterial Endotoxin Testing services and how we can assist you in maintaining the highest quality and safety standards in your product offerings.
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DR. Martinoz Scholtz
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