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Reducing microbial contamination via sterile risk assessment

20 April 2015 | By Guenther Gapp, Lachman Consulting Ltd/Independent Consultant

Several years ago, microbiologist Guenther Gapp created a new sterile risk assessment tool (based on a hazard operability analysis [HAZOP] approach) to identify and reduce the microbial contamination and compliance risk of aseptically-produced sterile products and production plants. The following article describes the operating principle of three risk analysis tools…

Real-time biological particle counting in environmental monitoring

20 April 2015 | By

The methods for monitoring air in cleanroom environments: viable counting techniques (settle plates and biological air samplers) and particle counters, are long established technologies and have been widely used in pharmaceutical manufacturing environments for decades. Although innovations have taken place with both particle counters and biological air samplers, primarily in…

The scope of PAT in real-time advanced control of tablet quality

20 April 2015 | By Ravendra Singh, Marianthi Ierapetritou and Rohit Ramachandran: Rutgers University

Continuous pharmaceutical manufacturing together with process analytical technology (PAT) provides a suitable platform for automatic feed-forward/feed-back (FF/FB) control of the end product quality as desired by quality by design (QbD)-based efficient manufacturing. The precise control of the quality of the pharmaceutical product requires proactive, corrective actions on the process/raw material…

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…

Application Note: Raman Analysis of Pharmaceutical Ingredients

12 January 2015 | By

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…