PAT - Articles and news items

IFPAC-2013: The Premier International Event on QbD and PAT

Featured news, News / 5 November 2012 / IFPAC

With over 25 topics covering all industry segments – IFPAC provides an opportunity to interact with other industries that have been using PAT for nearly 60 years!

(more…)

In-depth focus – Process Analytical Technology (PAT)

Issue 3 2012, Supplements / 6 July 2012 / Cenk Undey, Bryan Looze, Sinem Oruklu, Tony Wang, Rob Woolfenden, Erik Skibsted

This free to view Process Analytical Technology (PAT) in-depth focus is sponsored by FOSS NIRSystems, Siemens, Kaiser Optical Systems, Umetrics, Bruker:

• Process analytics experiences in biopharmaceutical manufacturing
  Cenk Undey, Bryan Looze, Sinem Oruklu, Tony Wang and Rob Woolfenden, Process and Systems Analysis, Process and Product Engineering, Amgen
• Correlation between powder rheology data and processability in solid dosage form manufacturing
  Erik Skibsted, Principal Scientist, Oral Protein Formulation, Novo Nordisk
• Ask the Expert
  Four expert industry users of process analytical technologies for pharmaceuticals pose one pressing question each for four leading vendor experts of process analytical technology.
  

(more…)

PHARMA•ID™ Raman spectrometer from DeltaNu

Featured news, News, Videos / 2 July 2012 / DeltaNu

PHARMA•ID™ is the smallest, lightest solution for cost-effective, non-destructive pharmaceutical identification. This palm-sized, easy to use Raman spectrometer identifies and validates excipients and active pharmaceutical ingredients (API) wherever testing is needed. PHARMA•ID can be used for the various phases of process analytical technology (PAT) systems and supports 21 CFR Part (more…)

Event: Advances in Raman spectroscopy in pharmaceutical analysis

Featured news, News / 23 March 2012 / The Joint Pharmaceutical Analysis Group (JPAG)

Date: Thursday 17 May 2012

Location: The Royal Society of Chemistry, London

Organised jointly by: the Federation of Analytical Chemistry and Spectroscopy Societies (FACSS), the Joint Pharmaceutical Analysis Group (JPAG), the Royal Society of Chemistry Molecular Spectroscopy Group (MSG) and the Infrared & Raman Discussion Group (IRDG)

(more…)

Free on-demand webinar: New monitoring methods improve compliance, reduce costs

Webinars / 9 February 2012 / HACH LANGE

Date: Available on-demand
Length: 1 hour

View presentations from experts in the fields of monitoring and compliance and pharmaceutical water and cleanroom facility standards:

• Regulation:
  Breaking news on the revision of ISO 14644 and 14698
• Water systems:
  How to meet EP TOC requirements with an on-line TOC analyzer designed for (more…)

PAT supplement (free to view)

Issue 6 2011, Supplements / 15 December 2011 / Terry McMahon (PAI Partners), Dr. Marianna Machin, Dr. Lorenz Liesum, Dr. Antonio Peinado (Novartis Pharma AG), Ravindra Dhumal, Tim Gough (Centre for Pharmaceutical Engineering Science, University of Bradford)

The historical development of the FDA’s PAT initiative and its present course (Terry McMahon, PAI Partners)

Implementation of modelling approaches in the QbD framework: Examples from the Novartis experience (Dr. Marianna Machin, Dr. Lorenz Liesum and Dr. Antonio Peinado, Novartis Pharma AG)

Challenges in development and implementation of spectroscopic techniques as PAT Analysers (Ravindra Dhumal and Tim Gough, Centre for Pharmaceutical Engineering Science, University of Bradford) (more…)

PAT & QbD Supplement (free to view)

Issue 3 2011 / 20 June 2011 / Magida Zeaiter - GlaxoSmithKline, Mark Morton - Phoenix Scientific Services, Joachim Ermer - Head of Quality Control Services Frankfurt Chemistry - Sanofi

Featuring articles: “A basis for innovation and continuous improvement of process understanding and control in pharmaceutical product development” by Magida Zeaiter, GlaxoSmithKline, “Flexible processing assures product quality” by Mark Morton, Phoenix Scientific Services and “Quality by design: A lifecycle concept for pharmaceutical analysis” by Joachim Ermer, Head of Quality Control Services Frankfurt Chemistry, Sanofi. (more…)

Market leaders Expo Technologies, Umetrics provide better PAT tool connectivity

Featured news, News / 18 April 2011 / Expo Technologies LLC

Expo Technologies (St. Louis, MO) and Umetrics Inc. (San Jose, CA), industry leaders in providing tools for Pharma PAT, announce the release of Expo’s NovaMath 5.0 with capability to use models built in SIMCA- P+ by the SIMCA-QP tool. This capability allows process measurement devices controlled by Expo’s NovaPAC/NovaMath applications to run Umetrics’ SIMCA- P+ models, in real time.

(more…)

Applying PAT in pharmaceutical processes

Issue 5 2010 / 1 November 2010 / 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 is to gain a deep understanding of manufacturing processes and to learn how to control them1. When processes are understood, opportunities for continuous improvement (quality and efficiency), cycle time reduction, cost reduction and QC lab test replacement arise. In this article, the strategy of Johnson & Johnson Pharmaceutical Research & Development (J&J PRD) towards the implementation of PAT in Pharmaceutical Process Development is explained and elucidated by case studies. (more…)

Process Analytical Technology: An industry perspective

Issue 4 2010 / 19 August 2010 / 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. In this roundtable, three leading pharmaceutical PAT companies offer their opinions on why PAT is becoming more and more essential to the pharmaceutical industry. (more…)

Article 3: The implementation of rapid microbiological methods

Issue 3 2010, Past issues / 24 June 2010 / 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 to effectively introduce a RMM in place of an existing microbiology method. This is especially true if the existing method is incorporated in a previously approved regulatory dossier, such as a New Drug Application (NDA) or Marketing Authorisation. (more…)

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

Issue 2 2010 / 9 May 2010 / 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 will be discussed. Secondly, the applicability of Raman spectroscopy for in-process monitoring of drug product production processes will be highlighted. In addition, the tendency within the pharmaceutical industry to move from batch processing towards continuous manufacturing will be envisaged. (more…)