Question

KNOW: High-risk CSPs (except those for inhalation or ophthalmic administration) that are made in groups of > ______ must also pass a bacterial endotoxin (pyrogen) test.

Answer 1

High-risk Compounded Sterile Preparations made in groups of over 25 units must be tested and pass a bacterial endotoxin test, as per standards set by AOAC International to ensure safety and efficacy.

Step-by-step explanation:

The requirement for high-risk Compounded Sterile Preparations (CSPs), with the exception of those intended for inhalation or ophthalmic use, is designed to ensure patient safety by minimizing the risk of introducing endotoxins, which are harmful bacterial by-products. When these CSPs are created in batches larger than 25 individual units, they must undergo and pass a bacterial endotoxin test to ensure they are free from these pyrogens.

The standard set by the Association of Official Agricultural Chemists International (AOAC International) mandates that at least 59 out of 60 replicates must show no bacterial growth to be considered safe. These standards ensure repeatable results across different batches of disinfectant and when tests are conducted on different days, thus ensuring the safety and efficacy of the disinfectant products as claimed by disinfectant manufacturers and in accordance with Environmental Protection Agency (EPA) guidelines.