The importance of sterility testing in biopharmaceutical manufacturing

Robust sterility testing protocols are essential to protect patients, medicine supply chains and manufacturers’ bottom lines. But how do companies build successful sterility processes?

What can pharmaceutical laboratories do to mitigate the risk of contamination during the manufacturing process?

Sterility testing is a crucial part of pharmaceutical manufacturing and the consequences of non‑compliance can be fatal. It is, however, a time and resource-hungry process, needing to be carried out under aseptic conditions by specialised staff according to detailed protocols.

Finished product samples must undergo a 14-day incubation period before being cleared for release onto the market. Anything less than a 100 percent pass rate can relegate an entire batch, preventing it from reaching the people who depend on it.

The key to helping pharmaceutical laboratories reduce the risk of avoidable test failures and smoothing the road from component intake to product release, is robust and validated protocols.