INSIGHTS ON QUALITY CONTROL

• Advancing Cell Therapy Manufacturing: Rapid Sterility Testing

  The rapid sterility test kit used in the study was able to quickly detect bacteria and fungi in complex cell therapy product matrices, detecting six species listed in USP chapter <71>.

• Challenges In Developing Medical Devices From Animal-Based Biomaterials In China

  Bovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.

• Effect Of X-Ray Inspection On Pharmaceutical Products

  Explore the use of X-ray inspection systems for the internal examination of pharmaceutical products, particularly non-transparent packaged drugs.

• Environmental Monitoring In Advanced Therapeutic Medicinal Products Facilities

  Discover how to adapt your environmental monitoring framework to meet the distinct risk-management and regulatory needs of ATMP facility production.

• Aseptic Expertise And Delivery Of Services

  8/20/2024

  A pharmaceutical services company sought expert intervention after a routine requalification of their aseptic simulation process revealed a contaminated unit, halting commercial production for two months.

• Pharmaceutical Requirements For Portable Monitoring In Cleanrooms

  3/5/2026

  Maintain rigorous pharmaceutical cleanroom standards through strategic environmental monitoring. Explore essential guidelines for particle detection and effective data analysis to ensure compliance.

• Continuous Monitoring Concept

  3/5/2026

  Transitioning from periodic testing to continuous monitoring is essential for modern aseptic safety. Learn how real-time particle tracking mitigates risk and ensures compliance.

• Deploying A Modern HPLC For Biopharma Analysis In QC Environments

  4/16/2024

  Explore findings from a study evaluating the performance of a modern HPLC system in comparison to a legacy system in a routine QC testing environment for biopharmaceuticals.

• Esco IntelliGlove Tester (EIGT)

  2/19/2026

  Ensure sterility with wireless glove leak testing. Align with Annex 1 and ISO standards through portable, traceable, and cable-free integrity checks that optimize cleanroom safety and workflows.