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
Extractable and leachable studies have become a hot topic within the Pharmaceutical industry. Some individuals consider Extractables and Leachables as one entity, but they are really considered two different studies.
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.
Let's take a moment to go into detail of one of the most widely used distribution simulation test methods, ASTM D4169 – Standard Practice for Performance Testing of Shipping Containers and Systems.
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
With the increasing utilization of ultracold frozen storage to maintain product potency, the question arises: how do we verify container closure integrity at these extremely low temperatures?
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