INSIGHTS ON PHARMACEUTICAL INSPECTION

• The Container Closure Integrity Requirements In The Revised EU Annex 1

  Learn about the advantages and disadvantages of CCI testing methods, how the revised EU Annex 1 may impact your strategy for ensuring CCI of sterile pharmaceutical products, and more.

• AMI 1000 – An Innovative CCIT Solution For The Pharmaceutical Industry

  This innovative CCIT solution based on Optical Emission Spectroscopy (O.E.S.) is an deterministic test method according to USP 1207 that can be used for in-process control during production or for laboratory purposes.

• Correlating Laser-Based Headspace Analysis To Helium Leak Rate Testing

  Laser-based headspace analysis is a non-destructive and rapid method for testing container closure integrity. We demonstrate that headspace analysis is equally as sensitive as helium leak rate testing.

• Container Closure Integrity Of Product Requiring Deep Cold Storage

  Gain insight into the risk to container closure integrity (CCI) during deep cold storage and identify appropriate analytical tools, to generate robust data to characterize and mitigate the risk to CCI.

• How To Select A Tracer Gas Leak Detection Method And Technology

  4/28/2022

  Here, we outline the best practice for leak testing of components in a broad range of applications and provide practical advice regarding the use of leak testing equipment.

• High Voltage Leak Detection For Parenteral Drug Container Closure Integrity

  2/25/2023

  Medical and pharmaceutical products are often packaged in fluid-filled containers. Learn about container closure integrity testing using high voltage leak detection (HVLD), how HVLD technology works, and more.

• Bombing - Leak Test Of Hermetically Sealed Objects

  4/28/2022

  Learn in detail about the best practice of leak testing of hermetically sealed devices in microelectronics, sensor technology, and other industries.

• Extractables And Leachables: Risk Management And Analytical Solutions

  10/11/2023

  Partnering with a CDMO that offers comprehensive and robust E&L studies can help facilitate a smooth product launch by ensuring minimal impact from impurities, all while mitigating risks.

• USP <922> Water Activity Has Opened A Door For OSD Manufacturers

  6/20/2022

  Learn more about USP <922> Water Activity and why using Karl-Fischer titration to measure total water content is no longer adequate to fully understand the stability of oral solid dosage products.