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
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
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
ISO 80369-7 is the newly published standard that replaces the ISO 594 series of standards. The ‘Part 7’ standard is specifically [...]
Method Validation effects the development and quality control testing of most products. Updated FDA guidance titled Analytical Procedures and Methods Validation for Drugs and Biologics
A few months back I published a blog article on the value of attending Interphex. For the regular readers (I know there are few), you will recall that I started that article by simply stating my dista
