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Issue #1 2015 – Digital edition
In Issue #1 2015: Regulatory Insight, Biologics, NIR in-depth focus, Raman in-depth focus, PAT, Drug Delivery, Microbiology Series and much more...
List view / Grid view
QA/QC
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Continued process verification – a challenge for the pharmaceutical industry?
10 March 2015 | By Michael Rommerskirchen, Boehringer Ingelheim
Nowadays, professional quality and process data trending is key for science-based pharmaceutical development and manufacturing. Recently, the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) issued revised process validation guidance to enforce recurring data analysis as a regulatory core requirement1,2: Periodic product and process monitoring, also known…
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Experts make pharma predictions for 2015: The good, the bad and the ugly
2 February 2015 | By CPhI Worldwide
Experts from CPhI Worldwide have shared their pharma predictions for 2015, suggesting that Continuous Manufacturing and QbD will expand, with FDA becoming ‘industry tutor’. However, pharma concerns about supply chain persist...
whitepaper
Application Note: Raman Analysis of Pharmaceutical Ingredients
A range of options is available for Raman analysis, including systems suitable for handheld, laboratory and educational applications. Systems typically include a spectrometer, laser, operating software and sampling accessories, while modular options are available for users to configure their own Raman systems. Setups are available for various wavelength ranges and…
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Issue #6 2014 – Digital edition
In Issue #6 2014: Polymerase Chain Reaction, Imaging, PAT in-depth focus, Screening in-depth focus, Microbiology Series and much more...
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Cocrystals: defining the opportunity
Cocrystals can help to address the manufacturability (flow, compaction, processability) as well as solubility/dissolution,hygroscopicity and stability properties of an active pharmaceutical ingredient (API).
webinar
Practical Application of RMM in Pharmaceutical Manufacturing
15 December 2014 | By BD Diagnostics
Discussion on how a rapid method can provide a solution to a common microbiological testing problem for pharmaceutical manufacturers – process water microbiology testing.
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CAMO release Service Pack 2014 for The Unscrambler® X Multivariate Data Analysis and Design of Experiments software
CAMO Software announced the launch of Service Pack 2014 for their all-in-one Multivariate Data Analysis (MVA) and Design of Experiments (DoE) software, The Unscrambler® X...
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Transmission Raman method gains regulatory approval for content uniformity batch release test
25 November 2014 | By Cobalt Light Systems
Cobalt Light Systems is pleased to announce that a major pharmaceutical company has gained regulatory approval to release products using Cobalt’s TRS100 instrument instead of by HPLC...
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Issue #5 2014 – Digital edition
In this issue: Protein Characterisation, RMM, Flow Cytometry, Spray drying, NMR spectroscopy, Raman, Pharmaceutical salts, Sterile Control Strategies and much more...
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Raman Spectroscopy: In-Depth Focus 2014
Sulaf Assi discusses the investigation of medicine quality using handheld Raman spectroscopy, a look at Raman hyperspectral imaging, plus Raman roundtable...
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NMR spectroscopy: a superior tool for quality control of pharmaceutical products
28 October 2014 | By Torgny Rundlöf, Pharmaceutical Evaluator, Medical Products Agency, Sweden
Pharmaceutical products have to be of high quality with respect to a number of predefined attributes, e.g. identity and strength with respect to the active pharmaceutical ingredient (API) and the presence and levels of impurities. At least for smaller compounds, such quality control often involves chromatographic methods. The examples given…
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METTLER TOLEDO’s XS Balance line delivers performance and ergonomics to safeguard health in the workplace
16 October 2014 | By METTLER TOLEDO
The extended and improved XS balance line incorporates patented weighing technologies to ensure accurate results whilst ergonomic design features provide outstanding comfort to protect user health during daily weighing tasks.
news
METTLER TOLEDO launch new XPE Balance portfolio designed for performance and ease of compliance
16 October 2014 | By METTLER TOLEDO
The new line of XPE balances focuses on delivering accurate, compliant results and provides users with a high level of process security, suitable for even the strictest regulations...
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B&W Tek announces new enhancements to NanoRam handheld Raman spectrometer
8 October 2014 | By B&W Tek
B&W Tek, is pleased to announce new enhancements to its NanoRam® handheld Raman spectrometer...
