| pyrogen removal | депирогенизация (Parenteral products must be sterile and pyrogen-free. Even if a product is sterile, it can still contain pyrogens. Depyrogenation is a process that removes pyrogens. The most prevalent and problematic pyrogens are the bacterial endotoxins found in the outer cell walls of gram-negative bacteria. Thus, depyrogenation is a process that will either destroy or remove bacterial endotoxins. Products can accumulate pyrogens from raw materials or other parts of the manufacturing process. The best pyrogen removal or destruction processes are product-dependent. Standard depyrogenation methods are dry heat, rinsing, and filtration. 'More) |
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