FEATURED ARTICLES

  • Analyzing FDA’s Draft Guidance On Premarket Review Of Combination Products
    Analyzing FDA’s Draft Guidance On Premarket Review Of Combination Products

    The new EU draft guidance, Guideline on the quality requirements for drug-device combinations, and U.S. draft guidance, Principles of Premarket Pathways for Combination Products, are the latest attempts by each body to adequately regulate combination products. In this two-part series, we examine the two guidances in detail. Part 1 covers the U.S. regulatory guidance.

More Featured Articles

WHITE PAPERS & CASE STUDIES

  • Smarter Flowmeters For Filling Applications
    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.

  • Calibration Management Increases Plant Availability
    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.

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

  • Bioprocess Plant Cuts Down Time With Self-Calibrating Temperature Sensor
    Bioprocess Plant Cuts 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 downtime to a minimum.

  • Advances In Temperature Calibration Procedures
    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.

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

More White Papers & Case Studies

PRODUCTS & SERVICES

Versa RxPharmaceutical Checkweigher Versa RxPharmaceutical Checkweigher

The Thermo Scientific™ Versa Rx Pharmaceutical Checkweigher is specifically designed to meet pharmaceutical Good Manufacturing Practice (GMP) standards, while delivering the highest level of accuracy and reliability.

Used Goring Kerr / Thermo Scientific Metal Detector Used Goring Kerr / Thermo Scientific Metal Detector

Used Goring Kerr Metal Detector, model DSP3, with reject on stand, serial# 05573699.

Used Perkin Elmer Elan 6100 ICP-MS Mass Spectrometer Used Perkin Elmer Elan 6100 ICP-MS Mass Spectrometer

Used Perkin Elmer Elan 6100 ICP-MS mass spectrometer, serial# 1820006.

Used Perkin Elmer Lambda 14 UV/VIS Spectrometer Used Perkin Elmer Lambda 14 UV/VIS Spectrometer

Used Perkin Elmer Lambda 14 UV/VIS Spectrometer, with controls on unit, 230 volts, serial# 50134.

Used Perkin Elmer Paragon 1000 PC FT-IR Spectrometer Used Perkin Elmer Paragon 1000 PC FT-IR Spectrometer

Used Perkin Elmer Paragon 1000 PC FT-IR Spectrometer, benchtop design, serial# 38716.

Used Nicolet Magna 560 IR Spectrometer Used Nicolet Magna 560 IR Spectrometer

Used Nicolet Magna 560 IR spectromerter.

Solutions To Improve Productivity While Lowering Your Costs Solutions To Improve Productivity While Lowering Your Costs

The combination of reliable products and expertise in customized solutions.

Endress+Hauser Service Portfolio Endress+Hauser Service Portfolio

Endress+Hauser is committed to your business, for improved plant performance.

More Products & Services