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Process Analytical Technologies (PAT)

 

NIR-based on-line monitoring of lyophilisation processes
NIR-based on-line monitoring of lyophilisation processes
article

PAT Series: Recent achievements in NIR-based on-line monitoring of lyophilisation processes

30 June 2016 | By Adrian Funke - Bayer Pharma AG / Reinhard Gross, Stephan Tosch and Albert Tulke - Bayer Technology GmbH

Process analytical technology (PAT), namely near-infrared (NIR) and Raman spectroscopy, has already been shown to be a useful tool for monitoring, analysing and optimising the complex process of lyophilisation. The latter process is especially challenging in the case of biopharmaceutical formulations due to the instability of active ingredients, leading to…

Exploring the advantages of PAT for pharmaceutical cleaning
Exploring the advantages of PAT for pharmaceutical cleaning
article

Exploring the advantages of PAT for pharmaceutical cleaning in Ireland

4 May 2016 | By Adeyinka Aina, University of Nottingham / Manuel Kuhs, Bernal Powder Engineering Research Group / Shaza Darwish, University of Limerick / Chris Edlin, Pharmaceutical Technology Manufacturing Centre

Process analytical technology (PAT) and its applications have been used in various industrial processes for a long time. It originates from the last century where its first application was in Germany after World War II within the chemical and petrochemical industry1. Following this, it was implemented and refined in different…

article

The application of skip testing to drug substance manufacture

29 February 2016 | By Phil Borman, Simon Bate and Keith Freebairn, GlaxoSmithKline

Skip testing is a process employed to reduce the analytical drugs testing burden and lends itself to processes with high frequency batch production. Rather than test all batches within a given interval, pre-selected batches are assessed and the other batches ‘skipped’. This reduction is justified as it is shown that…

Viavi application note MicroNIR
Viavi application note MicroNIR
whitepaper

Application Note: MicroNIR PAT for blend monitoring

18 January 2016 | By

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.

PAT In-Depth Focus 2015
PAT In-Depth Focus 2015
article

PAT In-Depth Focus 2015

6 January 2016 | By

Featuring an overview of process analytical control; Beyond API monitoring: in-line Raman spectroscopy for process control; Monitoring, understanding and assessing pharmaceutical process and product quality; and a PAT roundtable...

Continuous manufacturing in the pharma industry – an unstoppable trend?
Continuous manufacturing in the pharma industry – an unstoppable trend?
article

Continuous flow processing in the pharma industry – an unstoppable trend?

22 October 2015 | By Bernhard Gutmann and Christian Oliver Kappe, University of Graz

Continuous flow processes have many distinct advantages over discontinuous batch production and therefore, in the last century, continuous operation has become by far the most dominant form of production for high-volume and low-cost materials such as petrochemical and commodity chemicals. The first applications of continuous processes in the pharmaceutical industry…

PAT Series: Predictive monitoring and control approaches in biopharmaceutical manufacturing
PAT Series: Predictive monitoring and control approaches in biopharmaceutical manufacturing
article

PAT Series: Predictive monitoring and control approaches in biopharmaceutical manufacturing

3 September 2015 | By Cenk Undey, Tony Wang, Bryan Looze, Yingying Zheng and Myra Coufal - Amgen

Predictive monitoring is a key feature of biopharmaceutical manufacturing; making predictions about the key process end points such as process performance indicators or quality attributes using a process model offers the unique advantages of process improvement and optimisation, and helps give insights into variability.