Endotoxins are powerful pyrogens, which, if they gain access to the bloodstream, can cause fever, inflammation, and even septic shock. Moreover, endotoxins are ubiquitous in the environment, and there is a risk of endotoxin contamination not only of pharmaceutical drugs but also of medical devices. Contamination may occur during any stage of the manufacturing process, including contamination of raw materials and intermediate and final products.
To prevent these risks and to promote patient safety, bacterial endotoxin testing is required for all medical devices, such as implantable or liquid medical devices, which directly or indirectly come in contact with the cardiovascular system, lymphatic system, cerebrospinal fluid, or intraocular environment. This testing is generally performed using the Limulus amoebocyte lysate (LAL) assay.
Due to its high sensitivity and specificity, the LAL assay has been accepted as a method of choice for bacterial endotoxin testing. Accordingly, it has been adopted in the pharmacopoeias of the United States, European Union, and Japan. Moreover, the Unites States Food and Drug Administration (FDA) has recognized the role of the LAL assay for bacterial endotoxin testing for over four decades. After a series of earlier guidance documents, in 2012 the FDA published “Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers” to address key aspects of pyrogen and endotoxin testing.
To test medical devices for endotoxins, an extract, which serves as test solution, is prepared in aqueous medium. Depending on their type, medical devices may be rinsed, immersed, or disassembled. Traditionally, nonpyrogenic water or saline has been used to rinse medical devices for LAL testing. However, water or saline may not be sufficiently efficient in recovering endotoxin from the surface of medical devices. Therefore, there is a need to develop more reliable endotoxin extracting agents for medical device testing.
To address these challenges, FUJIFILM Wako has developed an endotoxin extracting solution containing human serum albumin (HSA), which can extract endotoxins from a wider range of medical device surfaces than water or saline solutions. FUJIFILM Wako’s extracting solution has been designed specifically for endotoxin testing of medical devices. Moreover, it is especially suitable for medical devices that may encounter ﬂuids containing blood or proteins. The solution can be stored conveniently at 2–10°C and is stable at this temperature range until its expiration date or for up to 1 year after dilution. The experimental conditions for the use of the solution have also been well defined, and incubation is performed for 1 h at room temperature.
Testing medical devices that come in contact with the cardiovascular system, lymphatic system, cerebrospinal fluid, or intraocular environment for bacterial endotoxins is critical to ensure patient safety, but achieving optimal endotoxin extraction may be challenging. FUJIFILM Wako’s endotoxin extracting solution ensures optimal endotoxin extraction from a wide range of medical device surfaces.