Detecting and quantifying these endotoxins is vital to ensure the safety and efficacy of medical devices and pharmaceuticals before they reach the market or are administered to patients. Protheragen-ING Lab specializes in providing comprehensive bacterial endotoxin testing (BET) services to ensure the safety and quality of medical devices and pharmaceutical products. Our BET testing services offer reliable and accurate results, enabling you to meet regulatory requirements and ensure the well-being of your end-users.
What is BET?
Bacterial endotoxins, also known as pyrogens, are an important consideration in the manufacturing process, as their presence can potentially pose a significant risk to patients. They can originate from various sources, such as raw materials, water, and equipment used in production.
BET is an in vitro assay for the detection and quantification of bacterial endotoxin, a component of the cell wall of gram-negative bacteria. The Limulus Amebocyte Lysate (LAL) test is another name for the assay. Because bacterial endotoxins can produce fever in mammals, including humans, the test is also referred to as a "pyrogen test".
The limit of bacterial endotoxins in medical devices
1. USP <85>:
- Intravenous infusion products: The limit is typically 0.5 endotoxin units (EU) per milliliter (ml) of product.
- Medical devices that contact the cardiovascular system, cerebrospinal fluid, or lymphatic system: The limit is usually 0.5 EU per device.
2. ISO 10993-11:
- Implantable devices: The limit is often specified as less than 20 EU per device.
3. ANSI/AAMI ST72:
- Circulatory Contacting: < 20 EU/device.
- Cerebrospinal Fluid Contacting: < 2.15 EU/device.
- Intraocular Devices: < 0.2 EU/device.
Our BET Testing Options
Protheragen-ING Lab offers a comprehensive range of BET testing options to meet different needs:
| Gel Gel Method | This method is similar to the horseshoe crab immune system response to endotoxin via coagulation and involves analyzing the dilution of the test extract and determining if the solution forms a solid gel in the presence of horseshoe crab-derived reagents. This method is a very manual test that produces only pass/fail results and is more subjective than other methods. The method is suitable for a wide range of applications and is specified in various pharmacopoeial monographs. |
| Kinetic turbidimetric method | This method utilizes the change in turbidity caused by the coagulation reaction between endotoxin and horseshoe crab-derived reagents. The turbidity or cloudiness of the sample affects the amount of light that can pass through the sample. It utilizes spectrophotometry to measure the intensity/absorbance of light that passes through the sample solution and correlates with the amount of endotoxin in the sample. The method has excellent sensitivity and is commonly used in the pharmaceutical and medical device industries, but is not suitable for colored, turbid, or highly viscous samples. |
| Kinetic Chromogenic Method | This method uses a chemically induced color change to measure endotoxin. The shade of color is proportional to the concentration of endotoxin. The color development method utilizes the initial portion of the endotoxin LAL reaction cascade to activate the enzyme, resulting in the release of p-nitroaniline from the synthetic material, producing yellow pigment. This method is highly sensitive and specific but is not applicable to samples with absorbance (pigment) at the measurement wavelength used for analysis. |
Our experienced team will guide you in selecting the most appropriate BET test method for your specific requirements and industry standards.
Why Choose Protheragen-ING Lab for BET?
Protheragen-ING Lab has a proven track record in providing high-quality BET services. Here's why you should choose us:
- Our team of highly skilled professionals has extensive knowledge and experience in BET testing. They are well-versed in the latest regulatory guidelines and industry standards, ensuring that your testing is performed accurately and efficiently.
- We have invested in cutting-edge laboratory facilities equipped with advanced instrumentation and technology. This enables us to perform BET testing using various methods, ensuring flexibility based on your specific requirements.
- Compliance with Applicable Standards: We strictly adhere to relevant industry standards and guidelines, such as the USP 85, USP 161, USP 797, EP 2.6.14, AAMI ST72, etc.
Contact us today to learn more about our BET testing options and how we can assist you in your quality control efforts.