INSIGHTS ON PHARMACEUTICAL INSPECTION

• USP <922> Water Activity Testing For Oral Solid Dose Pharmaceuticals

  Gain insight into the technical and regulatory justification for adding water activity measurements into pharmaceutical stability protocols.

• A High Sensitivity Solution For Pharma CCIT

  Experience a comprehensive CCIT solution completely adapted to the needs of pharma customers. The software features intuitive menus, simple navigation, 21 CFR part 11 compliance, traceability, and data storage.

• Correlating Stopper Height To Container Closure Integrity

  Learn how to comply with the new EU Annex 1 Section 8.28. Here, we describe a typical raised-stopper investigation and demonstrate how to generate scientifically robust data using headspace analysis.

• 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.

• The Golden Tool For Container Closure Integrity Testing

  8/17/2023

  Discover the power of headspace gas ingress in ensuring product quality. Dr. Derek Duncan, Director of Product Lines, Lighthouse Instruments, reveals the golden tool for container closure integrity testing.

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

  11/21/2022

  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.

• Choosing The Right Primary Container And Troubleshooting Issues

  8/25/2023

  Selecting the right primary container for an injectable drug product is critical. Discover how to identify relevant testing to de-risk your product development – and quickly uncover causes of failures.

• Container Closure Integrity Of Product Requiring Deep Cold Storage

  8/26/2022

  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 The Ideal Leak Testing Method For Your Application

  6/15/2022

  Here, we present the pros and cons of electronic leak testing methods and their suitability for different leak detection applications as well as professional advice on selection criteria.