The industry has made unprecedented progress and addressed several challenges to ensure compliance with pharmaceutical serialization and traceability requirements within each market. While these requirements contain further regulatory milestones on the horizon, manufacturers, distributors, pharmacies, and other parties in the pharmaceutical supply chain must systematically adopt serialization in their normal business operations.
Artesan Pharma Gmbh & Co. KG in Lüchow, Germany, demonstrates how an effective program of serialization, i.e. the traceability of medicines, can successfully be put into practice in today's pharmaceutical industry.
This guide explains the concept of metal detector sensitivity, key factors that impact it, and why a small difference in spherical sensitivity performance can mean a big difference in contaminants detected.
This white paper provides an explanation of the differences between validation, verification and routine performance monitoring as well as an overview of recommended test methods for different types of metal detection systems.
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.
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.
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.
ATC's Mass Extraction Technology takes advantage of the Micro-Flow phenomena and gas expansion, which occurs while the test is conducted in a vacuum.
The Thermo Scientific Versa Rx checkweigher provides superior quality to meet the most demanding performance standards.
Ropack Pharma Solutions provides a serialized supply chain that is proficient, verified and ready to safeguard your pharmaceutical product and the patients who depend on it.
Find metallic and non-metallic foreign objects using our entry-level X-ray inspection system
A general-purpose precision checkweigher with a cantilever design that scans at line speeds up to 350 packages per minute.
The quality, safety and effectiveness of drugs significantly depends on their proper packaging.
A versatile, scalable, fixed-height checkweigher ideal for products up to 10kg (22 pounds).
Our Medical Device Leak And Flow Testing capabilities surpass other existing methods. We offer nondestructive (NDT) leak testing instruments for your flexible and rigid products.
