Basics of Sterility Testing
According to research data from Pew Charitable Trusts, over 50 compounding errors with 1,227 adverse events and 99 deaths have been reported from 2001-2017. Contamination of sterile products was the most common compounding error.
Testing the finished drug product is important to ensure drugs delivered to patients are free of contamination.
USP <797> Pharmaceutical Compounding – Sterile Preparations states that certain compounded sterile preparations (CSPs) must undergo sterility testing prior to being dispensed. This requirement is based on multiple factors, including batch size, risk level, and storage conditions.
A validated sterility test can detect microbial contamination in a drug product.