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.
Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) Inductively coupled plasma-mass spectrometry (ICP-MS) is a powerful tool for analyzing trace metals in pharmaceuticals [...]
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
ASTM D 4169-14 is the current FDA approved consensus standard. The typical test regimen for medical device package testing is distribution cycle 13 (DC 13). The test intensity levels are most co
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
Significant product and package responses and interactions during shipment can be severe and may lead to package or product failure. Identification of critical frequencies and the nature of package stresses can aid in minimizing the effect of these occurrences.
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
To comply with regulatory expectations and ensure product safety, it’s critical for biopharma manufacturers to demonstrate and maintain container closure [...]
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