Controls, Validation, and Challenges of Bioburden Testing, Microbial Limits Testing, or Microbial Examination of Non-sterile products
In this first part of a series of blogs discussing High Voltage Leak Detection (HVLD), I will provide a general overview of one of the more popular HVLD units, an EScan 625 manufactured by PTI Inspect
Modern cleaning validation procedures must be implemented to prove that the equipment is reasonably free of any residue. It must be documented to be safe, causes no product quality concerns, and the process is contaminant-free in accordance with FDA, cGMPs, and USP guidelines.
Pharmaceutical products should contain low levels of residual solvents as determined by safety data. The presence of residual solvents in pharmaceutical products needs to be determined through testing
As development of biologics and biosimilars forges on, the autoinjector remains on the rise. Industry shifts to deterministic test methods translate to a need to develop and validate methods for autoinjectors