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29 February 2016 | By SOTAX Group
There are several sources of variability in the “inherently poor design” of compendial dissolution apparatus types. Nevertheless, dissolution testing is a QC requirement for many products, and so the industry faces the challenge of implementing and managing fleets of dissolution equipment. However, through instrument and process design and automation, managing…
Completing risk assessments is an inherent part of good manufacturing practice (GMP) and risk-based environmental control and monitoring (EM) in sterile product filling within isolators and restricted access barrier systems (RABS). This article considers the challenges the pharmaceutical industry faces in characterising conventional risk assessments like failure modes and effects…
In this article, Kerstin Barr, Product Manager for handheld Raman instruments at Thermo Fisher Scientific, comments on the revised tolerances...
The biopharmaceutical industry, especially manufacturing facilities, needs to implement bacterial identification to avoid the occurrence of a problematic microorganism in the final product that could be harmful for the end user and detrimental to a company’s finances and reputation.
27 January 2016 | By Colbalt Light System
Videos of the presentations from the world’s 1st TRS seminar for quantitative pharmaceutical analysis can be viewed on demand...
Raman monitoring of blended granule uniformity prior to tablet press...
The aim of Quality by Design (QbD) is to build quality into a product and process from the outset. The pharmaceutical and related industries utilise powder blending operations to make solid dose drugs, yet the phenomena of powder mixing is the least understood of all sciences.
Raman spectroscopy offers a rapid, convenient method for positive identification of pharmaceutical products and their raw materials – on the manufacturing floor, in inventory, and at the shipping dock.
Scandinavian Micro Biodevices (SMB), in Denmark, develops, produces and markets ‘point-of-care’ diagnostic systems for the veterinary market. In order to maintain a very low level of humidity in the clean room, a desiccant dehumidifier is required.
Heated crystalline pharmaceutical compounds undergo morphological changes that can be observed under a microscope. With hot-stage microscopy changes in melting points and ranges or crystallisation can be visualised for research and QC purposes in order to influence drug stability or effectiveness...
Monitoring the stability of the API under high humidity is critical to verify that the polymorphic active form remains intact. Being very chemically selective to subtle changes such as polymorphic forms, Raman spectroscopy is used to monitor and understand the stability of ingredients...
DiscoveRx Corporation, the leading supplier of innovative cell-based assays and services for drug discovery and development, announces the expansion of its PathHunter® cell-based assays portfolio with the release of PathHunter Interleukin cell-based assays.
7 January 2016 | By RADWAG
The X2 series embodies synergy between conventional solutions characteristic for high quality balances, and technology intended mainly for professional standards...
In digital version of Issue #6 2015: Microbiology, Screening, PCR, Continuous Manufacturing, PAT, Regulation, and much more...
Our Application Notes & Whitepapers supplement covers a wide variety of applications, from NMR, biosensors, Raman spectroscopy and QC to hot-stage microscopy...
