Process Analytical Technologies (PAT)

article

Applying PAT in pharmaceutical processes

1 November 2010 | By Mario Hellings, Tom Van den Kerkhof, Jeroen Geens and Steve Mehrman, Johnson & Johnson

As cited by the FDA, “Process Analytical Technology (PAT) is a system for designing, analysing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality.”1 The main goal of PAT…

article

Process Analytical Technology: An industry perspective

19 August 2010 | By Uwe Kirschner, General Manager, Sentronic GmbH, Rick E. Cooley, Market Development Manager - Process Analytics, Dionex Corporation, Rebecca Vangenechten, Business Development, Siemens Headquarters Pharma and Kjell François, Project Leader in PAT

Process Analytical Technology (PAT) is a system for designing, analysing and controlling pharmaceutical manufacturing processes through measurements of critical quality and performance attributes of raw and processed materials to ensure final product quality, the idea of which is to become more efficient while reducing over-processing, enhancing efficiency and minimising waste.…

article

Article 3: The implementation of rapid microbiological methods

24 June 2010 | By Michael J. Miller, Ph.D., President, Microbiology Consultants, LLC

This is the third in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2010. Rapid microbiological methods (RMMs) have been implemented by a number of companies around the world. In some cases, it is necessary to work with regulatory authorities in order…

article

Raman spectroscopy for the analysis of drug products and drug manufacturing processes

9 May 2010 | By Prof. Thomas De Beer, Assistant-Professor, Process Analytical Technology, Faculty of Pharmaceutical Sciences, University of Ghent

This article aims at supplying a concise overview on the application of Raman spectroscopic analysis methods within the pharmaceutical drug product manufacturing world. Firstly, there will be a focus on the rapid and nondestructive off-line analysis feasibility of Raman spectroscopy for final drug products. Herewith, several possible sources of error…

article

‘Pharmaceutical Industry / University’ R&D collaboration on Process Analytical Technologies

9 May 2010 | By Professor Nicolas Abatzoglou, Chair, PAT in Pharmaceutical Engineering, Department of Chemical and Biotechnological Engineering, Université de Sherbrooke

Process analytical technologies (PAT) are mature and well advanced in the classical chemical industry. Many successful industry/university R&D collaborations are aimed at the development of analytical methods and their application in process control. However, PAT in the pharmaceutical industry is a rather new field. It is precisely this latter reality…

article

Contributing to the Sustainability of the UK Chemicals and Pharmaceuticals Industries

22 February 2010 | By

The Centre for Process Analytics and Control Technology (CPACT) is a unique industry-driven multi-disciplinary research and development club that was formed in 1997 by the Departments of Pure and Applied Chemistry at the University of Strathclyde, the Department of Chemical and Process Engineering at the University of Newcastle and the…

article

Process Analytical Technology (PAT) in Freeze Drying: Tunable Diode Laser Absorption Spectroscopy as an evolving tool for Cycle Monitoring

12 December 2009 | By Stefan Schneid, Division of Pharmaceutics, Freeze Drying Focus Group, University of Erlangen-Nuremberg and Dr. Henning Gieseler, Division of Pharmaceutics, Freeze Drying Focus Group, University of Erlangen-Nuremberg

The most important critical product parameter during a freeze-drying process is the product temperature at the ice sublimation interface, Tp1. Once the product temperature in this area of interest exceeds the critical formulation temperature (typically denoted as "collapse temperature", Tc) during primary drying, a stepwise loss of the cake structure…

article

Real-time NIR monitoring of pharmaceutical blending processes with multivariate quantitative models

9 October 2009 | By Dr. Nicolas Abatzoglou, Professor and Chairman of the Department of Chemical & Biotechnological Engineering of the Université de Sherbrooke; Pierre-Philippe Lapointe-Garant, PAT Scientist and Jean-Sébastien Simard, Technical Services, both Wyeth Pharmaceuticals

Process analytical technology (PAT) initiatives are now an integral part of developmental efforts in the pharmaceutical industry. Many technical and scientific papers and even dedicated sections appear regularly in several pharmaceutical manufacturing publications. They may be part of a quality by design (QbD) project to better identify and understand critical…

article

Real-time environmental monitoring: PAT solutions using rapid microbiological methods

30 July 2009 | By Dr Michael J. Miller

In these economic times the pharmaceutical industry has expressed a renewed interest to explore ways in which to enhance the efficiency and agility of existing and future manufacturing processes. This is also true for laboratory-based operations that support forward processing and product release decisions. One function that can greatly benefit…

article

QbD and PAT: From Science to Compliance

30 July 2009 | By Pedro E. Hernandez-Abad, Associate Director; Jun Huang, Principal PAT Scientist II and Saly Romero-Torres, Principal PAT Scientist, both Wyeth Pharmaceuticals

Boards of health like the Food and Drug Administration and European Medicines Agency and ICH guidelines Q8, Q9 and Q10, provide a framework for Quality by Design (QbD) that fully integrates drug substance and drug product development with the principles of Quality Risk Management (QRM), Process Analytical Technology (PAT) and…

article

Applying PAT in Chemical Process Development

29 May 2009 | By

As the time-to-market of pharmaceutical products has elongated, while its prices are under big pressure, cost saving is currently essential in the pharmaceutical industry.

article

PAT Roundtable: trends and issues

7 February 2009 | By

European Pharmaceutical Review invited four individuals to discuss their views and opinions on current trends and issues surrounding PAT.

article

PAT Initiative review 2008

10 January 2009 | By Martin Warman, Director, MWC Ltd

As the industry approaches the five year anniversary of the ground breaking regulator initiatives (the ‘PAT framework' and ‘cGMPs for the 21st Century'1,2), it is time to assess the impact they have had on the industry and to look forward to what the industry may look like in another five…

article

From data to knowledge through smart Process Analytical Technologies (PAT) and process systems engineering

3 December 2008 | By

Pharma-Chem and bio-pharma development and production are now being profoundly influenced by the FDA PAT1 initiative with spectroscopic instrumentation being increasingly applied, or at the very least explored in product and process development and for on-line real-time process applications. The issues related to robust spectroscopic data analysis and calibration modelling…

article

Successful Process Analytical Technology (PAT) implementation in pharmaceutical manufacturing

29 September 2008 | By Thirunellai G. Venkateshwaran (Senior Director, New Products Quality, Global Quality and Compliance), John Levins (Senior Director, Technology Transfer & Process Innovation) and Stephen P. Simmons (Head of New Product Quality and Quality by Design), all Wyeth Pharmaceuticals

The use of Process Analytical Technology (PAT) while a relatively new concept to the Pharmaceutical Industry has been a tried and tested concept in the petrochemical industry for many years. The adaptation of PAT systems by the Pharmaceutical Industry was accelerated by the recent initiatives of the regulatory authorities globally…