Validation, Commissioning & Design White Papers & Case Studies

  1. 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.

  2. Enhanced Assurance Of Quality Supply For Single-Use Pre-designed Solutions

    The growing adoption of single-use technologies in all process steps of cGMP clinical and commercial production requires enhanced assurance of quality supply. Read how Resin specifications, process qualification and process controls established at all stages of the manufacturing process can ensure quality, change control and business continuity.

  3. Off-Line vs. In-Line Inspection: Risk Mitigation to Avoid Printing Errors

    Printing errors in pharmaceutical packaging are unfortunately inevitable. By integrating both on-line and off-line inspection systems, you improve the potential for cost savings by reducing the time and materials lost to avoidable errors, ultimately protecting not just your own bottom line but also your customer’s brand, not to mention their long-lasting satisfaction.

  4. Using Laser-Based Headspace Moisture Analysis For Rapid Nondestructive Moisture Determination Of Sterile Freeze-Dried Product

    Rapid water vapor determination with an optical method could replace the slow destructive traditional methods for the moisture analysis of freeze-dried product. A description of industry applications of headspace moisture analysis including freeze drying cycle optimization, lyo chamber moisture distribution mapping, and 100% moisture inspection of commercial freeze-dried product.

  5. 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.

  6. Introduction To Laser-Based Headspace Inspection And The Application To 100% Container Closure Inspection

    Gain insight into the process, ensure the maintenance of sterility for finished product after capping, and meet current regulatory guidance using laser-based headspace inspection.

  7. Quality Assurance Of Hotel Cosmetics

    Using checkweighers for 100% inline product control of bottles, jars and tubes.

  8. Smart Manufacturing Solutions Drive Digital Transformation in Life Sciences

    Innovative companies are now applying industry-specific Smart Manufacturing solutions to reduce time to value and improve efficiency and asset utilization while ensuring product and data integrity, regulatory compliance and safety.

  9. Leverage The Internet Of Things Within The Laboratory

    As science-based organizations look to leverage the internet of things (IoT) within the laboratory, careful consideration must be given to available technologies, data formats, and platforms.