INSIGHTS ON QUALITY ASSURANCE

• Flow And Level Instrument Verification In Pharmaceuticals

  Read how continual internal diagnostics and insitu verification capabilities leads to a better overall equipment effectiveness, resulting in less downtime and fewer unexpected shutdowns.

• Container Closure Integrity Of Sterile Vials During Deep Cold Storage

  Learn how rapid, nondestructive laser-based headspace analysis can support with data generation to demonstrate the maintenance of seal integrity during deep cold storage and transport.

• Advances In Temperature Calibration Procedures

  Recent developments eliminate the need for unnecessary calibrations and speed up the time it takes to do calibrations in the field.

• Microwave-Assisted Digestion Of Various Cannabis Products With Pressure-Activated Venting

  Due to the legalization of cannabis and the associated legislation concerning trace metal analysis the demand for fast and easy-to-use acid digestion techniques is increasing. HVT vessels with SMART VENT Technology enable the convenient and reliable digestion of cannabis-based products prior to spectroscopic analysis.

• In-Process Monitoring Of Headspace Oxygen Levels In Parenteral Containers

  Using a high sensitivity detection technique known as Frequency Modulation Spectroscopy (FMS), LIGHTHOUSE rapid non-destructive headspace oxygen inspection can help streamline the monitoring of purge performance on the filling line. This paper demonstrates the correlation of the FMS rapid non-destructive technique for analyzing headspace oxygen levels with the most commonly used conventional destructive techniques for headspace oxygen inspection.

• When Clean Is Critical—Understanding Parameters And Definitions Of Clean

  Clean room environments necessitate high-quality materials and equipment that conform to a variety of specified standards. This white paper explains how clean parameters are defined and validated.

• Container Closure Integrity Testing For Sterile Vial Products In Deep Cold Storage

  A vaccine-focused biotechnology company approached LIGHTHOUSE to help investigate a phenomenon observed in liquid vaccine product stored at -80°C. During QC testing, a number of vials were found to have an overpressure. This phenomenon represented a serious safety risk and LIGHTHOUSE was asked to support an investigation to identify the root cause.

• Non-Invasive Headspace Analysis For Automated Media Fill Microbial Inspection

  Laser-based headspace provides yet another alternative approach for detecting microbial contamination in sterile pharmaceutical product allows for quicker, more sensitive, accurate, and reproducible test results when compared with conventional, growth-based methods.

• External Management Improves Operational Quality

  A biotechnology plant was struggling with the management of the calibration of the more than 100 reference standards covered about 20 calibration service providers.