B/F test is a fundamental component of sterility method validation performed to ensure that a product does not interfere with the detection of viable microorganisms during sterility testing.

Introduction Sterility testing is critical in the pharmaceutical and medical device industries because it ensures that products intended for patient use are free from viable microorganisms. To perform sterility testing, two commonly referenced standards are available: USP <71> Sterility Tests and ISO 11737‑2: Sterilization of Health Care Products – Microbiological Methods, Part 2: Test of Sterility performed in the definition, validation, and maintenance of a sterilization p

Bioburden, the population of viable microorganisms found on a medical device, pharmaceutical raw material, or product prior to sterilization; is a critical parameter in medical device manufacturing. Determining the precise bioburden is essential for validating sterilization processes, ensuring product safety, and complying with stringent regulatory standards. The "best" testing method is not a one-size-fits-all solution; rather, it is a strategic choice based on the sample’s

Today, we’re going deeper into the microbial identification process, specifically, how to determine the source of microbial contamination in your facility. While this method doesn’t guarantee pinpoint accuracy, it offers valuable insights that can guide your environmental monitoring and root cause analysis.

This study found that after 6 days in the icebox with temperatures of roughly 20˚C, the EO recovery is still within an acceptable range. However, this does not extend to ECH and EG residues, which have a recovery rate of less than 80% after Day 1, possibly due to the increase in temperature above 10˚C.

ISO 17025:2017 requires that a decision rule should be applied to any statement of conformity to a specification or standard in a test...