Process Analytical Technology (PAT) Capabilities and Implementations under QbD Principles QbD and PAT Department

Size: px
Start display at page:

Download "Process Analytical Technology (PAT) Capabilities and Implementations under QbD Principles QbD and PAT Department"

Transcription

1 Process Analytical Technology (PAT) Capabilities and Implementations under QbD Principles QbD and PAT Department K1 Competence Center Initiated by the Federal Ministry of Transport, Innovation & Technology (MMVIT) and the Federal Ministry of Economics & Labour (BMWA). Funded by FFG, Land Steiermark and Steirische Wirtschaftsförderung (SFG).

2 Overview and Concepts Actual situation: Variable raw material properties + Fixed manufacturing process = Variable product quality (variable output) Quality check of raw materials Input Pharmaceutical manufacturing Process Fixed Process and low knowledge Quality Control (QC) of the final product Output Product waste Time delay Jan Page 2

3 Overview and Concepts Desired situation: Variable raw material parameters + Variable manufacturing process = Fixed output Quality check of raw materials Input Pharmaceutical manufacturing Process Variable Process and Mechanistic Understanding Quality Control (QC) of the final product (Prediction of Quality) Output PAT Product waste Real Time Release (RTR) Jan Page 3

4 Prior Knowledge Quality by Design Approach Pharmaceutical Quality System Pharmaceutical Quality System (ICH Q10) Quality Manual (ICH Q10) Quality Risk Management (ICH Q9) Criticality Assessment Risk Analysis Product Understanding critical Quality Attributes (cqas) Quality Target Product Profile (QTPP) Risk Analysis Process Understanding Process Analysis Inputs Outputs Process Analytical Technologies Process Modelling and Simulation Design of Experiment Operating Space Design Space Knowledge Space Risk Analysis Process Control Control Process Strategy Analytical for Technologies cpps Control Feedback Strategy Control for Loops cpps Real Feedback Time Release Control Loops Real Time Release Regulatory Implementation Knowledge Management (Q10) QbD documentation Product & Process Continuous Improvement Jan Page 4

5 Process Analytical Technology Analytical in the context of PAT includes much more than measuring, it is all about an overall process understanding! Measurement of Critical Attributes/Parameters Process analysers for in-line noninvasive quality monitoring Data Analysis and Management Design of Experiment (DoE) and Multivariate Data Analysis (MVDA) Process Control Knowledge based process understanding developement of a Design Space (DS) Jan Page 5

6 CFD-Simulation under QbD principles Fermentation Process Simulation-based design of a fermentation process and simulation validation Problem: No reliable simulation-based tools for bioreactor design exist Goal: Prediction of fermentation process performance depending on reactor design and operational parameters Concept: Use of CFD-simulation under QbD principles and validation of the simulation by means of literature and experimental data CFD bioreactor characterisation 1) oxygen saturation after air injection 2) bubble injection 3) velocity field Jan Page 6

7 ASA TAB MCC ASA*ASA TAB*TAB MCC*MCC ASA*TAB ASA*MCC TAB*MCC Application of Statistical Science Creation of Design Spaces Multivariate analyses of data Computation of parameter relations N=19 R2=0,774 RSD=0,8343 DF=13 Q2=0,374 Conf. lev.=0,95 Jan Page 7

8 Investigation of knowledge management application areas in pharma Development of an overall knowledge management platform and ensure essential functionalities Closing gap of information management and knowledge application Jan Page 8

9 PAT for Process Monitoring Multi-Probe-NIR-Spectrometer Prototype Testing and implementing a spectrometer prototype by EVK GmbH, Austria. Compact spectrometer with wavelength dispersion system 25 standardized ports for monitoring 25 fiber optic probes at once Simultaneous online monitoring of multiple process spots process steps multiple processes without differences between spectrometers no time delays Jan Page 9

10 PAT at Pharmaceutical Extrusion Monitoring and Supervisory Control Input parameters: Barrel temperatures Adapter temperature Screw speed Feed rate Output parameters: Barrel temperatures Adapter temperature Screw speed Feed rate Material pressure Material temperature Torque Spectrum Closed-Loop Control: Feedback connection via SIPAT Integration of Simca, Matlab, Camo into SIPAT system Jan Page 10

11 Monitoring of Continuous Processing Pharmaceutical Extrusion Monitoring of API content variations and residence time distribution with PLS model Investigation of the influence of kneading elements on API content fluctuations kneading screw standard deviation for 30 % API: 0.41 conveying screw standard deviation for 30 % API: 0.71 Jan Page 11

12 absorption units [a.u.] 2 nd principal component PAT at Tablet Press Monitoring of Powder Homogeneity Sentro probe Principle Component Analysis (PCA) shows clear differences over time Definition of limits (regions in PCA plot) to differentiate in spec and out of spec Filling shoe minor deviation main excipient API possible major deviation (last 30 sec of process) visible fluctuations wavelength [nm] 1 st principal component Jan Page 12

13 measured coating / desired coating level PAT at Tablet Coating in a Fluid Bed Monitoring of Coating Thickness Monitoring with NIR and Spatial Filter Velocimetry 100 % 0 % Parsum IPP 70-S 1.2 window fouling ( ) crystal coating ( ) % 100 % Time (h) Time (h) Time (h) Jan Page 13

14 Coatingprocess New PAT-Tool for Tablet Coating Optical Coherence Tomography Development of Pharma conform sensor Algorithm for coating thickness out of moving tablet bed Project Goal: In-line monitoring of coating process Jan Page 14 In cooperation with

15 Excerpt of Scientific Publications Adam, S., Suzzi, D., Radeke, C., Khinast, J. G., An integrated Quality by Design (QbD) approach towards design space definition of a blending unit operation by Discrete Element Method (DEM) simulation, Eur. J. Pharm. Sci. 42 (2011), 1-2, Koller D. M., Hannesschläger, G., Leitner, M., Khinast, J. G, Non-Destructive Analysis of Tablet Coatings with Optical Coherence Tomography, Eur. J. Pharm. Sci. 44 (2011), Hodzic, A., Llusa, M., Fraser, S. D., Scheibelhofer, O., Koller, D., Reiter, F., Laggner, P., D. M., Khinast, J. G., Small- and Wide-Angle X-Ray Scattering (SWAXS) for Quantification of Aspirin Content in a Binary Powder Mixture, Int. J. Pharm. 428 (2012), 1 2, Heigl, N., Hodzic, A., Llusa, M., Tritthart, W., Reiter, F., Fraser, S., Laggner, P., Khinast, J. G., Potential of Raman Spectroscopy for Evaluating Crushing Strength of Tablets, J. Pharm. Innov. 7 (2012), Hodzic, A., Llusa, M., Heigl, N., Tritthart, W., Fraser, S. D., Laggner, P., Khinast, J. G., Effect of process variables on the Small and Wide Angle X-Ray Scattering (SWAXS) patterns of powders, granules and pharmaceutical tablets, Powd. Tech. 221 (2012), Scheibelhofer, O., Hohl, R., Salar-Behzadi, S., Haack, D., Koch, K., Kerschhaggl, P., Sacher, S., Menezes, J., Khinast, J. G., Fluid bed in a Flash, AIChE Annual Meeting 2012, Pittsburgh Wahl, P., Markl, D., Treffer, D., Menezes, J., Koscher, G., Roblegg, E., Khinast, J. G., PAT for Pharmaceutical Extrusion Monitoring and Supervisory Control, AIChE Annual Meeting 2012, Pittsburgh Scheibelhofer, O., Balak, N., Wahl, P., Koller, D., Glasser, B. J., Khinast, J. G., Monitoring Blending of Pharmaceutical Powders with Multipoint NIR Spectroscopy, AAPS Pharm. Sci. Tech. (2012), in press Scheibelhofer, O., Balak, N., Koller, D., Khinast, J. G., Spatially Resolved Monitoring of Powder Mixing Processes via Multiple NIR-Probes, Powd. Tech., accepted for publication Jan Page 15

16 Concluding Remarks RCPE: the one stop point for QbD & PAT pre-industrial research projects Pharmaceutical Engineering Matching specific PAT tools with user requirements Interaction of PAT-tools, models and control software Risk Analysis with state-of-art tools Design of Experiments, Design-space development Multivariate Data Analysis QbD implementations and training Qualification of equipment and analytical methods Jan Page 16

17 Contacts Dr. Thomas K. Klein Director Business Dr. Stephan Sacher Team Leader QbD/PAT Contacts: phone: +43/316/873/30959 Prof. Dr. Johannes G. Khinast Director Science Contacts: phone: +43/316/873/7978 Contacts: phone: +43/316/873/30900 Dr. Simon Fraser, ppa. Deputy Director Contacts: phone: +43/316/873/30907 Massimo Bresciani Director Scientific Operations Contacts: phone: +43/316/873/30915 Jan Page 17

Modeling and Simulation of Complex Multiphase Flows in the Pharmaceutical Industry

Modeling and Simulation of Complex Multiphase Flows in the Pharmaceutical Industry SIMNET Days 2010 Februar 10, 2010 Modeling and Simulation of Complex Multiphase Flows in the Pharmaceutical Industry D. Suzzi a, G. Toschkoff a, S. Radl a,b, Th. Hörmann a, M. Schaffer a, D. Machold a,

More information

Multivariate Chemometric and Statistic Software Role in Process Analytical Technology

Multivariate Chemometric and Statistic Software Role in Process Analytical Technology Multivariate Chemometric and Statistic Software Role in Process Analytical Technology Camo Software Inc For IFPAC 2007 By Dongsheng Bu and Andrew Chu PAT Definition A system Understand the Process Design

More information

Quality by Design Approaches to Analytical Methods -- FDA Perspective. Yubing Tang, Ph.D. FDA/CDER/ONDQA AAPS, Washington DC October 25, 2011

Quality by Design Approaches to Analytical Methods -- FDA Perspective. Yubing Tang, Ph.D. FDA/CDER/ONDQA AAPS, Washington DC October 25, 2011 Quality by Design Approaches to Analytical Methods -- FDA Perspective Yubing Tang, Ph.D. FDA/CDER/ONDQA AAPS, Washington DC October 25, 2011 1 Outline What is Quality by Design (QbD) Role of Analytical

More information

Workshop B Control Strategy

Workshop B Control Strategy ICH-GCG ASEAN Workshop B Control Strategy Jean-Louis ROBERT, Ph.D. National Health Laboratory, Luxembourg Chair-person ICH IWG Q8, Q9, Q10 Kuala Lumpur, 26-28 July 2010 International Conference on Harmonisation

More information

Pharmaceutical Quality Systems: US Perspective

Pharmaceutical Quality Systems: US Perspective Pharmaceutical Quality Systems: US Perspective Rick Friedman Associate Director, Office of Manufacturing and Product Quality Center for Drug Evaluation and Research Topics Background: The ICH Q10 Pharmaceutical

More information

Multivariate Tools for Modern Pharmaceutical Control FDA Perspective

Multivariate Tools for Modern Pharmaceutical Control FDA Perspective Multivariate Tools for Modern Pharmaceutical Control FDA Perspective IFPAC Annual Meeting 22 January 2013 Christine M. V. Moore, Ph.D. Acting Director ONDQA/CDER/FDA Outline Introduction to Multivariate

More information

Guidance for Industry

Guidance for Industry Guidance for Industry Q8, Q9, and Q10 Questions and Answers(R4) U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics

More information

NIR Chemical Imaging as a Process Analytical Tool

NIR Chemical Imaging as a Process Analytical Tool NIR Chemical Imaging as a Process Analytical Tool NIR chemical imaging greatly extends the capability of NIR spectroscopy, and is the only PAT-applicable blend monitoring technique that gives both statistical

More information

Annual Scientific Report

Annual Scientific Report Annual Scientific Report 2012 2013 www.rcpe.at Research Center Pharmaceutical Engineering GmbH Managing Director: Mag. DI Dr. Thomas K. KLEIN Scientific Director: Univ.-Prof. DI Dr. Johannes G. KHINAST

More information

Chemometric Analysis for Spectroscopy

Chemometric Analysis for Spectroscopy Chemometric Analysis for Spectroscopy Bridging the Gap between the State and Measurement of a Chemical System by Dongsheng Bu, PhD, Principal Scientist, CAMO Software Inc. Chemometrics is the use of mathematical

More information

Multi- and Megavariate Data Analysis

Multi- and Megavariate Data Analysis Multi- and Megavariate Data Analysis Basic Principles and Applications Third revised edition L. Eriksson, T. Byrne, E. Johansson, J. Trygg and C. Vikström Chapter 18 Process Analytical Technology (PAT)

More information

Pharmaceutical Engineering: The Lisbon Masters Program

Pharmaceutical Engineering: The Lisbon Masters Program EAFP Catania June 24-26, 26, 2010 Pharmaceutical Engineering: The Lisbon Masters Program José Menezes, Rogério Gaspar, João Bordado,, José Morais Technical University of Lisbon (Portugal) Faculty of Pharmacy,

More information

Optical coherence tomography as a tool for non destructive quality control of multi-layered foils

Optical coherence tomography as a tool for non destructive quality control of multi-layered foils Optical coherence tomography as a tool for non destructive quality control of multi-layered foils Günther Hannesschläger, Alexandra Nemeth, Christian Hofer, Christian Goetzloff, Jens Reussner, Karin Wiesauer,

More information

QbD in der Praxis systematisches Vorgehen bei der Entwicklung pharmazeutischer Herstellprozesse. Adrian Funke

QbD in der Praxis systematisches Vorgehen bei der Entwicklung pharmazeutischer Herstellprozesse. Adrian Funke QbD in der Praxis systematisches Vorgehen bei der Entwicklung pharmazeutischer Herstellprozesse Adrian Funke Symposium der Fachgruppe Arzneimittelkontrolle / Pharmazeutische Analytik der DPhG Freiburg

More information

On-Line Monitoring of A Granulation Process By NIR Spectroscopy

On-Line Monitoring of A Granulation Process By NIR Spectroscopy On-Line Monitoring of A Granulation Process By NIR Spectroscopy MANEL ALCALÀ, 1 MARCELO BLANCO, 1 MANEL BAUTISTA, 1 JOSEP M. GONZÁLEZ 2 1 Departament de Química, Unitat de Química Analítica, Universitat

More information

Fusion Pro QbD-aligned DOE Software

Fusion Pro QbD-aligned DOE Software Fusion Pro QbD-aligned DOE Software Statistical Experimental Design Analysis & Modeling Robustness Simulation Numerical & Graphical Optimization 2D, 3D, & 4D Visualization Graphics 100% aligned with Quality

More information

PHARMACEUTICAL DEVELOPMENT

PHARMACEUTICAL DEVELOPMENT INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE PHARMACEUTICAL DEVELOPMENT Q8(R2) Current Step

More information

Q8(R2): Pharmaceutical Development

Q8(R2): Pharmaceutical Development ICH-GCG ASEAN Q8(R2): Pharmaceutical Development Jean-Louis ROBERT, Ph.D. National Health Laboratory, Luxembourg Chair-person ICH IWG Q8, Q9, Q10 Kuala Lumpur, 26-28 July 2010 International Conference

More information

QUALITY BY DESIGN (QBD) : A COMPLETE REVIEW

QUALITY BY DESIGN (QBD) : A COMPLETE REVIEW Review Article QUALITY BY DESIGN (QBD) : A COMPLETE REVIEW Nishendu P. Nadpara*, Rakshit V. Thumar, Vidhi N. Kalola, Parula B. Patel Department of Quality Assurance, S. J. Thakkar Pharmacy College, Opp.

More information

Control Strategy Case Studies

Control Strategy Case Studies Control Strategy Case Studies Vance Novack, GSK Workshop on Implementation of ICH Q8/Q9/Q10 and Other Quality Guidelines Beijing, China, Dec 2008 Control Strategy Case Studies The information and knowledge

More information

ICH guideline Q8, Q9 and Q10 - questions and answers volume 4

ICH guideline Q8, Q9 and Q10 - questions and answers volume 4 December 2010 EMA/CHMP/ICH/265145/ Committee for medicinal products for human use (CHMP) ICH guideline Q8, Q9 and Q10 - questions and answers volume 4 Step 5 Transmission to CHMP for information December

More information

Process analytical technology PAT for the life sciences industry

Process analytical technology PAT for the life sciences industry analytical technology PAT for the life sciences industry PAT for life sciences A quality by design (QbD) approach using process analytical technology (PAT) requires more than a collection of analyzers

More information

PARTICLES 2013. Fully Coupled Multiphase Simulation of a Bottom-spray Wurster-Coater using a hybrid CPU/GPU CFD/DEM Approach

PARTICLES 2013. Fully Coupled Multiphase Simulation of a Bottom-spray Wurster-Coater using a hybrid CPU/GPU CFD/DEM Approach PARTICLES 2013 Fully Ced Multiphase Simulation of a Bottom-spray Wurster-Coater usg a hybrid CPU/GPU CFD/DEM Approach D. Jajcevic, A.C. Radeke, E. Siegmann, G. Neubauer, J.G. Khast K1 Competence Center

More information

QbD Considerations for Analytical Methods - FDA Perspective

QbD Considerations for Analytical Methods - FDA Perspective QbD Considerations for Analytical Methods - FDA Perspective IFPAC Annual Meeting Baltimore, January 25, 2013 Sharmista Chatterjee, Ph.D. CMC Lead for QbD ONDQA/CDER/FDA Outline Role of analytics in drug

More information

Continuous Granulation and Drying

Continuous Granulation and Drying Continuous Granulation and Drying Collette TM Technologies GEA Pharma Systems GEA Pharma Systems supplies advanced technologies for the processing of Active Pharmaceutical Ingredients (API) for the production

More information

Contents. Preface XIII List of Contributors. Part One Process Control and Quality Assurance 1

Contents. Preface XIII List of Contributors. Part One Process Control and Quality Assurance 1 V Contents Preface XIII List of Contributors XV Part One Process Control and Quality Assurance 1 1 Industrial Perspectives 3 Andreas Kandelbauer, Manfred Rahe, and Rudolf W. Kessler 1.1 Introduction and

More information

Module 13 : Measurements on Fiber Optic Systems

Module 13 : Measurements on Fiber Optic Systems Module 13 : Measurements on Fiber Optic Systems Lecture : Measurements on Fiber Optic Systems Objectives In this lecture you will learn the following Measurements on Fiber Optic Systems Attenuation (Loss)

More information

A Preliminary Proposal for a Pharmaceutical Engineering Graduate Program

A Preliminary Proposal for a Pharmaceutical Engineering Graduate Program A Preliminary Proposal for a Pharmaceutical Engineering Graduate Program Planning Committee: Prabir Basu Steve Byrn Ken Morris Rex Reklaitis Paul Sojka Venkat Venkatasubramanian Carl Wassgren National

More information

Quality by Design (QbD) Overview

Quality by Design (QbD) Overview Quality by Design (QbD) Overview Gary Warren Director, Haemostasis and Thrombosis R&D October, 2015 CSL Behring Pty Ltd Broadmeadows, Victoria What is Quality by Design (QbD)? QbD is: A Quality System

More information

Terry Blevins Principal Technologist Emerson Process Management Austin, TX

Terry Blevins Principal Technologist Emerson Process Management Austin, TX Terry Blevins Principal Technologist Emerson Process Management Austin, TX QUALITY CONTROL On-line Decision Support for Operations Personnel Product quality predictions Early process fault detection Embedded

More information

Engineering Standards Advance PAT

Engineering Standards Advance PAT Engineering Standards Advance PAT By Manuel Hormaza, CEO and Founder, IBS Caribe We often look at PAT as a limited initiative, usually with a focus on a regulatory mandate and a possible break to speed

More information

Making Improvement Work in Pharmaceutical Manufacturing Some Case Studies. Ronald D. Snee

Making Improvement Work in Pharmaceutical Manufacturing Some Case Studies. Ronald D. Snee Making Improvement Work in Pharmaceutical Manufacturing Some Case Studies Ronald D. Snee ISPE Midwest Extended Education and Vendor Day Overland Park, KS 2 May 2007 King of Prussia PA New York NY Washington

More information

Commercial Manufacturing - Qualification & Validation-related GMP Deficiencies and Other Lifecycle Considerations

Commercial Manufacturing - Qualification & Validation-related GMP Deficiencies and Other Lifecycle Considerations Commercial Manufacturing - Qualification & Validation-related GMP Deficiencies and Other Lifecycle Considerations Kevin O Donnell PhD Market Compliance Manager, IMB PDA / FDA Conference Pharmaceutical

More information

Fundamentals of modern UV-visible spectroscopy. Presentation Materials

Fundamentals of modern UV-visible spectroscopy. Presentation Materials Fundamentals of modern UV-visible spectroscopy Presentation Materials The Electromagnetic Spectrum E = hν ν = c / λ 1 Electronic Transitions in Formaldehyde 2 Electronic Transitions and Spectra of Atoms

More information

Quality by Design Application and Perspectives for biologicals. K. Ho, CHMP Biologics Working Party

Quality by Design Application and Perspectives for biologicals. K. Ho, CHMP Biologics Working Party Quality by Design Application and Perspectives for biologicals K. Ho, CHMP Biologics Working Party Pharmaceutical development (Q8) Aim: To design a quality product and a manufacturing process to consistently

More information

Process Validation Protocol (Reference: SOP )

Process Validation Protocol (Reference: SOP ) Project Name Equipment Manufacturer Process Line/Location Project Number Serial Number Model Number Protocol number [Enter Product Title, Number & Strength] MULTI VITAMIN TABLETS PRODUCT CODE: Name: Position:

More information

Industrial Process Monitoring Requires Rugged AOTF Tools

Industrial Process Monitoring Requires Rugged AOTF Tools Industrial Process Monitoring Requires Rugged AOTF Tools Dr Jolanta Soos Growth has been rapid in the use of spectroscopic methods to monitor industrial processes, both in production lines and for quality

More information

Potential use of handheld Raman devices as tools for screening medicines for quality

Potential use of handheld Raman devices as tools for screening medicines for quality Potential use of handheld Raman devices as tools for screening medicines for quality Mustapha Hajjou Program Manager U.S Pharmacopeia Convention Patrick Lukulay Vice President United States Pharmacopia

More information

Workshop A Design Space (DS)

Workshop A Design Space (DS) Implementation of ICH Q8, Q9, Q10 Workshop A Design Space (DS) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Disclaimer The information

More information

The complexity of today s pharmaceutical

The complexity of today s pharmaceutical Reprinted from PHARMACEUTICAL ENGINEERING The Official Magazine of ISPE This article presents a holistic approach to pharmaceutical manufacturing based on product and process knowledge that allows companies

More information

Title: Near infrared and Raman spectroscopy for the in-process monitoring of pharmaceutical production processes

Title: Near infrared and Raman spectroscopy for the in-process monitoring of pharmaceutical production processes biblio.ugent.be The UGent Institutional Repository is the electronic archiving and dissemination platform for all UGent research publications. Ghent University has implemented a mandate stipulating that

More information

O2PLS for improved analysis and visualization of complex data

O2PLS for improved analysis and visualization of complex data O2PLS for improved analysis and visualization of complex data Lennart Eriksson 1, Svante Wold 2 and Johan Trygg 3 1 Umetrics AB, POB 7960, SE-907 19 Umeå, Sweden, lennart.eriksson@umetrics.com 2 Umetrics

More information

How To Use Mva And Doe

How To Use Mva And Doe Bring data to life Multivariate Data Analysis for Biotechnology and Bio-processing Powerful Multivariate Data Analysis and Design of Experiments methods are giving biotechnology companies greater insights

More information

Process Systems Engineering in Pharmaceutical Development & Manufacture

Process Systems Engineering in Pharmaceutical Development & Manufacture Process Systems Engineering in Pharmaceutical Development & Manufacture G.V. Rex Reklaitis School of Chemical Engineering Purdue University In Sympathy with Tom Edgar s 65 th Birthday NSF ERC FOR STRUCTURED

More information

Corona process The new ZEISS spectrometer system for the food industry

Corona process The new ZEISS spectrometer system for the food industry Interactive PDF Version 1.0 Start Trust needs reliability quality needs ZEISS The real challenge is to offer a product with consistent quality using raw materials which are themselves subject to ongoing

More information

pharmaceutical 2009/2010 www.rcpe.at Research Center Pharmaceutical Engineering Annual Scientific Report

pharmaceutical 2009/2010 www.rcpe.at Research Center Pharmaceutical Engineering Annual Scientific Report Research Center Pharmaceutical Engineering Annual Scientific Report 2009 / 2010 www.rcpe.at Annual Scientific Report 2009/2010 research center pharmaceutical engineering www.rcpe.at Table of Contents Introduction

More information

CERTIFICATE. on Product Conformity (QAL 1) Number of Certificate: 0000037051. GM32 ln-situ-gasanalysator model Cross Duct for NO and S02

CERTIFICATE. on Product Conformity (QAL 1) Number of Certificate: 0000037051. GM32 ln-situ-gasanalysator model Cross Duct for NO and S02 Umwelt Bundes Amt @ For our Environment A TÜVRheinland Precisely Right. CERTIFICATE on Product Conformity (QAL 1) Number of Certificate: 0000037051 Certified AMS: Manufacturer: Test Institute: GM32 ln-situ-gasanalysator

More information

Process Validation: Practical Aspects of the New FDA Guidance

Process Validation: Practical Aspects of the New FDA Guidance Process Validation: Practical Aspects of the New FDA Guidance ISPE Boston Chapter Meeting April 18, 2013 Rusty Morrison Commissioning Agents, Inc. Objectives / Summary What is Process Validation? Regulatory

More information

EDQM: 50 YEARS OF LEADERSHIP IN THE QUALITY OF MEDICINES PAVING THE WAY FOR THE FUTURE

EDQM: 50 YEARS OF LEADERSHIP IN THE QUALITY OF MEDICINES PAVING THE WAY FOR THE FUTURE EDQM: 50 YEARS OF LEADERSHIP IN THE QUALITY OF MEDICINES PAVING THE WAY FOR THE FUTURE 6-8 October 2014 Strasbourg, France WORKSHOP QUALITY BY DESIGN 1 The Pharmacopoeia and QbD 7 October 2014 Dr. Øyvind

More information

ICH Q10 and Change Management: Enabling Quality Improvement

ICH Q10 and Change Management: Enabling Quality Improvement ICH Q10 and Change Management: Enabling Quality Improvement Bernadette Doyle PhD Vice President and Head of Global Technical Group Global Manufacturing and Supply GlaxoSmithKline Overview Drivers for Change

More information

White paper. info.sipat@siemens.com ı www.siemens.com/sipat

White paper. info.sipat@siemens.com ı www.siemens.com/sipat info.sipat@siemens.com ı www.siemens.com/sipat White paper TABLE OF CONTENTS INTRODUCTION... 3 EXECUTIVE SUMMARY... 4 1. PAT WHAT, WHY AND HOW?... 6 1.1. What is PAT?... 6 1.2. The regulatory impetus for

More information

ANEXO VI. Near infrared transflectance spectroscopy. Determination of dexketoprofen in a hydrogel. M. Blanco y M. A. Romero

ANEXO VI. Near infrared transflectance spectroscopy. Determination of dexketoprofen in a hydrogel. M. Blanco y M. A. Romero ANEXO VI Near infrared transflectance spectroscopy. Determination of dexketoprofen in a hydrogel M. Blanco y M. A. Romero Enviado para su publicación NEAR INFRARED TRANSFLECTANCE SPECTROSCOPY. Determination

More information

NIRCal Software data sheet

NIRCal Software data sheet NIRCal Software data sheet NIRCal is an optional software package for NIRFlex N-500 and NIRMaster, that allows the development of qualitative and quantitative calibrations. It offers numerous chemometric

More information

Preface Light Microscopy X-ray Diffraction Methods

Preface Light Microscopy X-ray Diffraction Methods Preface xi 1 Light Microscopy 1 1.1 Optical Principles 1 1.1.1 Image Formation 1 1.1.2 Resolution 3 1.1.3 Depth of Field 5 1.1.4 Aberrations 6 1.2 Instrumentation 8 1.2.1 Illumination System 9 1.2.2 Objective

More information

Guideline on Process Validation

Guideline on Process Validation 1 2 3 4 29 March 2012 EMA/CHMP/CVMP/QWP/70278/2012-Rev1 Committee for Medicinal Products for Human Use (CHMP) Committee for Medicinal Products for Veterinary Use (CVMP) 5 6 Draft Draft Agreed by CHMP /

More information

Homeland Security, Medical, Pharmaceutical and Non-destructive Testing Applications of Terahertz Radiation

Homeland Security, Medical, Pharmaceutical and Non-destructive Testing Applications of Terahertz Radiation Applications of THz Radiation APS March Meeting, March 23, 2005 Homeland Security, Medical, Pharmaceutical and Non-destructive Testing Applications of Terahertz Radiation Colin Baker colin.baker@teraview.com

More information

Realization of a UV fisheye hyperspectral camera

Realization of a UV fisheye hyperspectral camera Realization of a UV fisheye hyperspectral camera Valentina Caricato, Andrea Egidi, Marco Pisani and Massimo Zucco, INRIM Outline Purpose of the instrument Required specs Hyperspectral technique Optical

More information

In this column installment, we present results of tablet. Raman Microscopy for Detecting Counterfeit Drugs A Study of the Tablets Versus the Packaging

In this column installment, we present results of tablet. Raman Microscopy for Detecting Counterfeit Drugs A Study of the Tablets Versus the Packaging Electronically reprinted from June 214 Molecular Spectroscopy Workbench Raman Microscopy for Detecting Counterfeit Drugs A Study of the Tablets Versus the Packaging With the increasing proliferation of

More information

Measurement & Analytics Measurement made easy

Measurement & Analytics Measurement made easy Measurement & Analytics Measurement made easy MB3600-PH Versatile FT-NIR analyzer for the life sciences and pharmaceutical industries Designed for QA/QC, research and development and at-line PAT applications

More information

Sensitivity and Selectivity in Optical Spectroscopy and Imaging: A Molecular Approach

Sensitivity and Selectivity in Optical Spectroscopy and Imaging: A Molecular Approach Sensitivity and Selectivity in Optical Spectroscopy and Imaging: A Molecular Approach Process Analysis & Technology Prof. Dr. R. W. Kessler STZ Technology Process Control and Data Analysis 72762 Reutlingen,

More information

ANALYTICAL METHODS INTERNATIONAL QUALITY SYSTEMS

ANALYTICAL METHODS INTERNATIONAL QUALITY SYSTEMS VALIDATION OF ANALYTICAL METHODS 1 GERT BEUVING INTERNATIONAL PHARMACEUTICAL OPERATIONS TASKS: - Internal auditing - Auditing of suppliers and contract manufacturers - Preparing for and guiding of external

More information

SGS: Das Scanning Grating Spektrometer Ein kleines, günstiges Spektrometermodul auf Basis eines dispersiven Mikrosystems

SGS: Das Scanning Grating Spektrometer Ein kleines, günstiges Spektrometermodul auf Basis eines dispersiven Mikrosystems the leading supplier of Micro Scanning Devices Your Micro Optical Solution IPHT-Workshop 11.-12.03.08 We move the light for you! SGS: Das Scanning Grating Spektrometer Ein kleines, günstiges Spektrometermodul

More information

Asian Journal of Food and Agro-Industry ISSN 1906-3040 Available online at www.ajofai.info

Asian Journal of Food and Agro-Industry ISSN 1906-3040 Available online at www.ajofai.info As. J. Food Ag-Ind. 008, (0), - Asian Journal of Food and Agro-Industry ISSN 906-00 Available online at www.ajofai.info Research Article Analysis of NIR spectral reflectance linearization and gradient

More information

From Lifecycle Modelling to Lifecycle Analysis A Framework for Interactive Visualisation of Lifecycle Information

From Lifecycle Modelling to Lifecycle Analysis A Framework for Interactive Visualisation of Lifecycle Information From Lifecycle Modelling to Lifecycle Analysis A Framework for Interactive Visualisation of Lifecycle Information Christian Kaiser VIRTUAL VEHICLE Research Center COMET K2 Competence Center - Initiated

More information

How To Make A Plasma Control System

How To Make A Plasma Control System XXII. Erfahrungsaustausch Mühlleiten 2015 Plasmaanalyse und Prozessoptimierung mittels spektroskopischem Plasmamonitoring in industriellen Anwendungen Swen Marke,, Lichtenau Thomas Schütte, Plasus GmbH,

More information

QbD based Development and Characterization of a Cell Culture Process for Therapeutic Proteins

QbD based Development and Characterization of a Cell Culture Process for Therapeutic Proteins QbD based Development and Characterization of a Cell Culture Process for Therapeutic Proteins 2015. 06. 09 Green Cross Corp. Green Cross Research Center Yong Jae Kim (YJKIM@greencross.com) Biologics World

More information

PHARMACEUTICAL REFERENCE STANDARDS

PHARMACEUTICAL REFERENCE STANDARDS PHARMACEUTICAL REFERENCE STANDARDS 11 th International Symposium organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe 3-4 September 2012, Strasbourg,

More information

2.3 QUALITY OVERALL SUMMARY Sakura Tablet

2.3 QUALITY OVERALL SUMMARY Sakura Tablet English Mock QOS P2_Final_June08 MODULE 2: COMMON TECHNICAL DOCUMENT SUMMARIES Generic name: Amokinol 2.3 QUALITY OVERALL SUMMARY Sakura Tablet 1 English Mock QOS P2 Final TABLE OF CONTENTS Page Table

More information

Optical or Acoustic Process measurement of liquids Turbidity Colour Oil in Water Water in Oil Oil on Water Process UV- Photometry

Optical or Acoustic Process measurement of liquids Turbidity Colour Oil in Water Water in Oil Oil on Water Process UV- Photometry Optical or Acoustic Process measurement of liquids Turbidity Colour Oil in Water Water in Oil Oil on Water Process UV- Photometry Models UVS-1, MoniSpec-UV & MoniSpec-UVd Model UVS-1 general information

More information

MPA. Innovation with Integrity. Multi Purpose Analyzer FT-NIR

MPA. Innovation with Integrity. Multi Purpose Analyzer FT-NIR MPA Multi Purpose Analyzer Innovation with Integrity FT-NIR Discover the Flexibility of FT-NIR Spectroscopy The MPA is the result of almost 40 years of experience in the engineering and production of FT-IR

More information

PIPELINE LEAKAGE DETECTION USING FIBER-OPTIC DISTRIBUTED STRAIN AND TEMPERATURE SENSORS WHITE PAPER

PIPELINE LEAKAGE DETECTION USING FIBER-OPTIC DISTRIBUTED STRAIN AND TEMPERATURE SENSORS WHITE PAPER PIPELINE LEAKAGE DETECTION USING FIBER-OPTIC DISTRIBUTED STRAIN AND TEMPERATURE SENSORS WHITE PAPER Lufan Zou and Taha Landolsi OZ Optics Limited, 219 Westbrook Road, Ottawa, ON, Canada, K0A 1L0 E-mail:

More information

LabRAM HR. Research Raman Made Easy! Raman Spectroscopy Systems. Spectroscopy Suite. Powered by:

LabRAM HR. Research Raman Made Easy! Raman Spectroscopy Systems. Spectroscopy Suite. Powered by: LabRAM HR Research Raman Made Easy! Raman Spectroscopy Systems Powered by: Spectroscopy Suite Cutting-Edge Applications with the LabRAM HR Deeply involved in Raman spectroscopy for decades, HORIBA Scientific

More information

Data Analysis and Effectiveness Models

Data Analysis and Effectiveness Models Reprinted from PHARMACEUTICAL ENGINEERING The Official Magazine of ISPE March/April 2007, Vol. 27 No. 2 This article introduces a data analysis maturity model that maps various tools and methodologies

More information

The Mantid Project. The challenges of delivering flexible HPC for novice end users. Nicholas Draper SOS18

The Mantid Project. The challenges of delivering flexible HPC for novice end users. Nicholas Draper SOS18 The Mantid Project The challenges of delivering flexible HPC for novice end users Nicholas Draper SOS18 What Is Mantid A framework that supports high-performance computing and visualisation of scientific

More information

Research Article Prospective Validation of Paracetamol Tablet Dosage Form

Research Article Prospective Validation of Paracetamol Tablet Dosage Form Research Article Prospective Validation of Paracetamol Tablet Dosage Form Nidhi Aswal *, Pallavi Joshi, Alka N Choudhary and Preeti Kothiyal Department of Quality Assurance, Shri Guru Ram Rai Institute

More information

Towards large dynamic range beam diagnostics and beam dynamics studies. Pavel Evtushenko

Towards large dynamic range beam diagnostics and beam dynamics studies. Pavel Evtushenko Towards large dynamic range beam diagnostics and beam dynamics studies Pavel Evtushenko Motivation Linacs with average current 1-2 ma and energy 1-2.5 GeV are envisioned as drivers for next generation

More information

Jorge E. Fernández Laboratory of Montecuccolino (DIENCA), Alma Mater Studiorum University of Bologna, via dei Colli, 16, 40136 Bologna, Italy

Jorge E. Fernández Laboratory of Montecuccolino (DIENCA), Alma Mater Studiorum University of Bologna, via dei Colli, 16, 40136 Bologna, Italy Information technology (IT) for teaching X- and gamma-ray transport: the computer codes MUPLOT and SHAPE, and the web site dedicated to photon transport Jorge E. Fernández Laboratory of Montecuccolino

More information

The ability of a manufacturing process to

The ability of a manufacturing process to Exclusive On-Line Article PHARMACEUTICAL ENGINEERING The Official Magazine of ISPE November/December 2006, Vol. 26 No. 6 The Product Quality Research Institute (PQRI) is collaborative effort between the

More information

Application Note. The Optimization of Injection Molding Processes Using Design of Experiments

Application Note. The Optimization of Injection Molding Processes Using Design of Experiments The Optimization of Injection Molding Processes Using Design of Experiments PROBLEM Manufacturers have three primary goals: 1) produce goods that meet customer specifications; 2) improve process efficiency

More information

Nano-Spectroscopy. Solutions AFM-Raman, TERS, NSOM Chemical imaging at the nanoscale

Nano-Spectroscopy. Solutions AFM-Raman, TERS, NSOM Chemical imaging at the nanoscale Nano-Spectroscopy Solutions AFM-Raman, TERS, NSOM Chemical imaging at the nanoscale Since its introduction in the early 80 s, Scanning Probe Microscopy (SPM) has quickly made nanoscale imaging an affordable

More information

Control of Temperature Profile in the Injection Molding Process for Part Consistency

Control of Temperature Profile in the Injection Molding Process for Part Consistency 17 th European Symposium on Computer Aided Process Engineering ESCAPE17 V. Plesu and P.S. Agachi (Editors) 2007 Elsevier B.V. All rights reserved. 1 Control of Temperature Profile in the Injection Molding

More information

Spectral Measurement Solutions for Industry and Research

Spectral Measurement Solutions for Industry and Research Spectral Measurement Solutions for Industry and Research Hamamatsu Photonics offers a comprehensive range of products for spectroscopic applications, covering the, Visible and Infrared regions for Industrial,

More information

LabRAM HR Evolution. Research Raman Made Easy!

LabRAM HR Evolution. Research Raman Made Easy! LabRAM HR Evolution Research Raman Made Easy! Cutting-Edge Applications with the LabRAM HR LabRAM HR Deeply involved in Raman spectroscopy for decades, HORIBA Scientific has been providing an extensive

More information

WOOD WEAR TESTING USING TRIBOMETER

WOOD WEAR TESTING USING TRIBOMETER WOOD WEAR TESTING USING TRIBOMETER Prepared by Duanjie Li, PhD 6 Morgan, Ste156, Irvine CA 92618 P: 949.461.9292 F: 949.461.9232 nanovea.com Today's standard for tomorrow's materials. 2015 NANOVEA INTRO

More information

Energy and Thermal Management Simulation of an Advanced Powertrain

Energy and Thermal Management Simulation of an Advanced Powertrain Energy and Thermal Management Simulation of an Advanced Powertrain Armin Traußnig VIRTUAL VEHICLE Research Center 04.10.2013 COMET K2 Competence Center - Initiated by the Federal Ministry of Transport,

More information

Pharmaceutical Product Quality, Quality by Design, cgmp, and Quality Metrics

Pharmaceutical Product Quality, Quality by Design, cgmp, and Quality Metrics Pharmaceutical Product Quality, Quality by Design, cgmp, and Quality Metrics Lawrence X. Yu, Ph.D. Deputy Director Office of Pharmaceutical Quality Center for Drug Evaluation and Research Food and Drug

More information

Model Order Reduction for Linear Convective Thermal Flow

Model Order Reduction for Linear Convective Thermal Flow Model Order Reduction for Linear Convective Thermal Flow Christian Moosmann, Evgenii B. Rudnyi, Andreas Greiner, Jan G. Korvink IMTEK, April 24 Abstract Simulation of the heat exchange between a solid

More information

Monitoring and Control Tools for Implementing PAT

Monitoring and Control Tools for Implementing PAT Supplement to Monitoring and Control Tools for Implementing PAT Terry Blevins and James Beall AUTHORS Innovations in process analysis and control offer significant opportunities for improving pharmaceutical

More information

Proposals of Summer Placement Programme 2015

Proposals of Summer Placement Programme 2015 Proposals of Summer Placement Programme 2015 Division Project Title Job description Subject and year of study required A2 Impact of dual-polarization Doppler radar data on Mathematics or short-term related

More information

Audit Report and Requirements of Mantid Software from the Molecular Spectroscopy Group (2013)

Audit Report and Requirements of Mantid Software from the Molecular Spectroscopy Group (2013) Audit Report and Requirements of Mantid Software from the Molecular Spectroscopy Group 1. Current Status (2013) The current status of the data analysis software, Mantid, corresponding to each group instrument

More information

Edited by. C'unter. and David S. Moore. Gauglitz. Handbook of Spectroscopy. Second, Enlarged Edition. Volume 4. WlLEY-VCH. VerlagCmbH & Co.

Edited by. C'unter. and David S. Moore. Gauglitz. Handbook of Spectroscopy. Second, Enlarged Edition. Volume 4. WlLEY-VCH. VerlagCmbH & Co. Edited by C'unter Gauglitz and David S. Moore Handbook of Spectroscopy Second, Enlarged Edition Volume 4 WlLEY-VCH VerlagCmbH & Co. KGaA IX Volume 4 Section XII Applications 6: Spectroscopy at Surfaces

More information

High Resolution Spatial Electroluminescence Imaging of Photovoltaic Modules

High Resolution Spatial Electroluminescence Imaging of Photovoltaic Modules High Resolution Spatial Electroluminescence Imaging of Photovoltaic Modules Abstract J.L. Crozier, E.E. van Dyk, F.J. Vorster Nelson Mandela Metropolitan University Electroluminescence (EL) is a useful

More information

Simulation and Optimisation of a Pharmaceutical Production Line

Simulation and Optimisation of a Pharmaceutical Production Line International Journal of Emerging Engineering Research and Technology Volume. 2, Issue 6, September 2014, PP 64-71 ISSN 2349-4395 (Print) & ISSN 2349-4409 (Online) Simulation and Optimisation of a Pharmaceutical

More information

Use of the ambr 250 in combination with high-throughput design and analysis tools for rapid, scalable USP development

Use of the ambr 250 in combination with high-throughput design and analysis tools for rapid, scalable USP development Use of the ambr 250 in combination with high-throughput design and analysis tools for rapid, scalable USP development Authors: Dr Fern Slingsby and Dr Simon Dewar Upstream Process Development FUJIFILM

More information

Getting Answers at the Source Requires a New Way of Thinking About Software

Getting Answers at the Source Requires a New Way of Thinking About Software m o l e c u l a r s p e c t r o s c o p y RESULT Software Getting Answers at the Source Requires a New Way of Thinking About Software Method Development Workflow Development Deployment & Support Methodology

More information

HPLC Analysis of Acetaminophen Tablets with Waters Alliance and Agilent Supplies

HPLC Analysis of Acetaminophen Tablets with Waters Alliance and Agilent Supplies HPLC Analysis of Acetaminophen Tablets with Waters Alliance and Agilent Supplies Application Note Small Molecule Pharmaceuticals Authors Jignesh Shah, Tiantian Li, and Anil Sharma Agilent Technologies,

More information

Thermal processing for drying, heating and cooling

Thermal processing for drying, heating and cooling Komline-Sanderson Paddle Dryer/Cooler Thermal processing for drying, heating and cooling Komline - Sanderson Thermal processing with the K-S Paddle Dryer/Cooler With the K-S Paddle Dryer/Cooler, powdered,

More information

DETERMINATION OF API CONTENT IN A PILOT-SCALE BLENDING BY NEAR-INFRARED SPECTROSCOPY AS A FIRST STEP METHOD TO PROCESS LINE IMPLEMENTATION

DETERMINATION OF API CONTENT IN A PILOT-SCALE BLENDING BY NEAR-INFRARED SPECTROSCOPY AS A FIRST STEP METHOD TO PROCESS LINE IMPLEMENTATION Acta Poloniae Pharmaceutica ñ Drug Research, Vol. 70 No. 3 pp. 419ñ429, 2013 ISSN 0001-6837 Polish Pharmaceutical Society DETERMINATION OF API CONTENT IN A PILOT-SCALE BLENDING BY NEAR-INFRARED SPECTROSCOPY

More information

Back to Basics Fundamentals of Polymer Analysis

Back to Basics Fundamentals of Polymer Analysis Back to Basics Fundamentals of Polymer Analysis Using Infrared & Raman Spectroscopy Molecular Spectroscopy in the Polymer Manufacturing Process Process NIR NIR Production Receiving Shipping QC R&D Routine

More information

11.I In-process control Authors: Dr. Christian Gausepohl / Paolomi Mukherji / Update 07

11.I In-process control Authors: Dr. Christian Gausepohl / Paolomi Mukherji / Update 07 In-process control In-process control Authors: Dr. Christian Gausepohl / Paolomi Mukherji / Update 07 Here you will find answers to the following questions: What are the in-process control tasks? Where

More information