Drugmakers using a sterility assurance release program can take a pass on sterility testing of finished units, according to FDA guidance. In a parametric release program, a drugmaker's demonstrated ...

The 14-day turn around time of current compendial sterility testing is plainly insufficient for a wide range of crucial, life-saving drugs and therapies, including an increasing number of novel cell ...

Currently established rapid methods for sterility testing of advanced therapy medicinal products (ATMPs) are mostly based on growth-based processes or the detection of metabolic activities. However, ...

A domestic research team has developed a technology that can complete sterility testing of pharmaceuticals in just one day. Previously it took two weeks (14 days) to check the results, but this ...

Seoul National University College of Engineering announced that a research team led by Professor Sunghoon Kwon from the Department of Electrical and Computer Engineering, in collaboration with ...

Sterility test bottles, some with obvious microbial growth and some without. "The need for sterility assurance arises from the fact that if I sterilize a batch of products and then test 20 of them to ...

Green Valley Drugs, in Henderson, Nevada, has voluntarily recalled all lots of all sterile products compounded, repackaged, and distributed by the pharmacy due to "lack of sterility assurance," the ...