Pharmaceutical Validation

Analyzing FDA’s Draft Guidance On Premarket Review Of Combination Products
The new EU draft guidance, Guideline on the quality requirements for drug-device combinations, and U.S. draft guidance, Principles of Premarket Pathways for Combination Products, are the latest attempts by each body to adequately regulate combination products.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.

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
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
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
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
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
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.

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.