Often in the microbial examination of products, physical issues occur that force adaptations to the sample preparation. Some of these challenges include viscosity, the need for mixing or blending to a
The microbiological examination of products can often prove challenging when the product is antimicrobial. This is often by design, but can also be inherent to the excipients, inherent to the active p
Suitability Testing is integral to any Microbiological test system. Suitability testing demonstrates that the test system and methodology are suitable for the intended purpose and compatible with the
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.
Quality Assurance Units must provide assurance that the validation process has produced the expected results as per the requirements of USP General Chapter <233> Elemental Impurities in accordance with <1225> Validation of compendial procedures