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In mammalian-cell-based bioprocesses the most common critical process parameters (CPPs) include physical parameters (temperature, pressure, dissolved oxygen [DO] levels) as well as chemical properties (pH, concentrations of both substrates and byproducts) and biochemical properties (cell number and viability, cell physiology).
22 March 2016 | By Cherwell Laboratories
New 2016 Redipor® price list available on request...
In Issue #1 2016: Regulation, Drug Delivery, Raman, PAT, Formulation, NIR, Microbiology, and much more...
In this Raman In-Depth Focus: Raman as a valuable tool in high-throughput screening; Use of Raman in analysing polymorphism in pharmaceutical drugs; Upcoming Raman calibration standards; Raman roundtable...
Historically, dissolution testing has been used primarily as a quality control (QC) test for solid oral drug products1. Indeed, it is the only QC test which provides a measure of the quantitative release rate of the drug from the pharmaceutical product. More recently, the test has been proposed in lieu…
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...
