Validation, Commissioning & Design White Papers & Case Studies

  1. Smarter Flowmeters For Filling Applications

    RONCHI MARIO developed its new filler around Endress+Hauser's new Dosimag and Dosimass flowmeters. The new filling machine generation of RONCHI MARIO S.p.A. features major innovations. Endress+Hauser's Dosimag and Dosimass flowmeters with integrated batching functionality are key components of the new machine concept.

  2. Calibration Management Increases Plant Availability

    Thanks to the set-up of a result-based calibration contract with Endress+Hauser and to the simplification of the operation, this major biotechnology plant has significantly reduced overall effort and calibration costs. The calibration time has also decreased, with positive impact on the plant process’s availability rate.

  3. External Management Improves Operational Quality And Increases Reference Meters’ Availability

    A biotechnology plant was struggling with the management of the calibration of the more than 100 reference standards covered about 20 calibration service providers. Endress+Hauser took the responsibility to manage the whole calibration process of the reference standards resulting in a reduction of non-conformities achieved has led to better operational quality.

  4. Bioprocess Plant Reduces Down Time With Self-Calibrating Temperature Sensor

    To keep the risks in bioproduction as low as possible, an increase in calibration frequency is required. Read how the self-calibrating iTHERM TrustSens temperature sensor kept Plant downtime and calibration times to a minimum.

  5. 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.

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

    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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.