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Topic: Instrumentation
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White Papers: In depth research
| Title | Author | Date |
| Overall Labor Effectiveness (OLE) Achieving a Highly Effective Workforce | Kronos Inc. | 04/25/2008 |
| Help your manufacturing business increase productivity and profitability through Overall Labor Effectiveness (OLE), a Kronos-developed key performance indicator that measures your workforce. As a companion to OEE (Overall Equipment Effectiveness), OLE gives your company the ability to analyze the impact of direct and indirect workforce output so that you can take action to reduce costs and to identify productivity opportunities. | ||
| Development and Validation of a Corona CAD Method for Simultaneous Determination of Peptides, Lipids and Lipid-Impurities in the Synthetic Pulmonary Surfactant Formulation Surfaxin | ESA Biosciences, Inc. | 02/08/2008 |
| Rigorous validation of an analytical method utilizing the Corona CAD for measuring major components and impurities in a peptide/lipid drug product formulation is presented in this white paper by ESA Biosciences, Inc. The Corona CAD met or exceeded specification requirements (precision, ruggedness, LOQ, etc.). Implementation resulted in significant time and cost savings for the researchers as sample preparation was greatly simplified and a number of analyses were able to be performed simultaneously. | ||
| Satisfying GMP with Handheld Near-Infrared Analyzers in the Pharmaceutical Industry | Polychromix, Inc. | 11/16/2007 |
| Identification and qualification of incoming pharmaceutical raw materials as well as properties of finished forms can be rapidly determined. Handheld near-infrared analyzers significantly enhance workflow and productivity. | ||
| Achieving Optimal Particle Size Distribution in Inhalation Therapy | Bob Bruno, Microfluidics Corp. | 07/17/2007 |
| Obtaining consistent, appropriate particle size for certain inhaled drugs has been a troublesome task. Pharmaceutical companies are currently developing methods for producing aerosolized formulations containing uniform, optimally sized particles. | ||
| Particle Counting in Injectable Solutions | Particle Measuring Systems | 07/17/2007 |
| This paper, by Particle Measuring Systems, in its third revision, discusses the requirements laid out by US (USP), European (EP), and Japanese (JP) Pharmacopoeia standards and includes the most recent USP 788 (April 2007), EP 5.1 and JP 15 release information. These standards demand that injectable solutions are effectively monitored for microcontamination, specifically non-soluble particulates. | ||
| PAT Needs and Applications in the Bioprocess Industry | Markku Känsäkoski, Marika Kurkinen, Niklas von Weymarn and Pentti Niemelä, VTT; Peter Neubauer and Esko Juuso, University of Oulu; Tero Eerikäinen, Helsinki University of Technology; and Seppo Turunen, Sirkka Aho and Pirkko Suhonen, Medipolis GMP Oy, Finland | 04/03/2007 |
| In this comprehensive report, the authors examine what PAT means in practice for the biotechnological manufacture of pharmaceuticals. They analyze regulatory issues, monitoring methods and available technologies, and compare their findings against the needs for monitoring in bioprocess-based pharmaceutical production. | ||
| Using NIR to Monitor Lubricant Uniformity in a Granule Blend | Krishel Naicker and Gareth Kilian, Nelson Mandela Metropolitan University, and Johan Olivier, Aspen Pharmacare | 03/06/2007 |
| Researchers from Aspen Pharmacare and Nelson Mandela Metropolitan University, South Africa, have developed a method to monitor blending, in real time, by monitoring the change in absorbance of both granule and magnesium stearate lubricant. Krishel Naicker, Gareth Kilian and Johan Olivier describe their method and results. | ||
| Multivariate Calibration: A Science-Based Method | Ralf Marbach, VTT Optical Instruments Center | 12/06/2006 |
| A new method for multivariate calibration is less costly to implement than standard PLS or PCR methods, and eliminates the need to introduce additional variability into an otherwise stable process. It also allows specific responses to be proven from first principles. | ||
| From Procedural to Risk-Based Compliance and Enforcement | John Blanchard, ARC Advisory Group | 10/30/2006 |
| In this presentation, ARC analyst John Blanchard outlines the steps required for moving from the old to the new model, and what they mean for pharmaceutical manufacturers and the FDA. | ||
| Kick–Starting PAT to Achieve Quality by Design in cGMP Bioprocessing | TechniKrom, Inc. | 10/02/2006 |
| Since 2002, the FDA has promoted a continuous, process-centric approach to validation vs. the prior product–centric one. Yet, many pharma and biopharma companies have failed to incorporate that approach into their strategic plan. This white paper explains the new distinctions and what they mean in practice, then identifies PAT opportunities that can be implemented immediately to support QBD activities. | ||
| New IR Calibration Technique Curbs Costs | Ralf Marbach, VTT Electronics, Technical Research Center of Finland | 09/29/2006 |
| The standard industry practice of "statistical" calibration to achieve optical measurements is inefficient whenever a priori physical knowledge about the spectral signal and/or noise is available, argues Prof. Ralf Marbach of the Technical Research Center of Finland. In this white paper, Marbach describes a new method that cuts calibration costs by about one-third. | ||
| Raman Microscopy: An Essential Aid in Characterizing Drug Delivery Products | Eunah Lee, Ph.D. and Fran Adar, Ph.D., Horiba Jobin Yvon | 07/28/2006 |
| Raman microscopy provides information about molecular organization and crystalline order at the resolution of optical microscopy at the sub micron scale, and is being used to characterize drug delivery materials. This white paper by Horiba Jobin Yvon discusses the mapping of creams, timed-release solids and stents, and how Raman maps provide hyperspectral cubes from which images can be reconstructed that show distribution, dissolution and molecular associations. | ||
| Assessment of Risk Factors in Container-Closure Systems | Thomas A. Jennings, Ph.D., Phase Technologies Inc. | 06/27/2006 |
| This paper looks at applying Process Analytical Technologies to the lyophilization process to mitigate risk factors that could lead to producing a poor product. Dr. Jennings argues that risk can be lowered by increasing the number of samples, thereby raising the confidence level and reducing the confidence interval. | ||
| A Science-based Performance Comparison of On-line TOC Analyzers | GE Analytical Instruments | 05/15/2006 |
| As more and more pharmaceutical companies switch from laboratory TOC analysis to PAT-friendly, on-line, real-time release systems, decision makers need to know the critical parameters for success. This white paper from GE Analytical Instruments examines the performance capabilities of various on-line TOC analyzers to help would-be purchasers make decisions with confidence. | ||
| Dealing with Disparity in On-line and Off-line pH Measurements | Heather Evans and Tina Larson, Genentech, Inc. | 04/26/2006 |
| Genentech found pH drift in its on-line measurements for a cell culture process, and continues to investigate its cause. | ||
| Case Study: Hungarian Pharma Co. Revamps Digital Plant Architecture | Emerson Process Management | 03/08/2006 |
| When Gedeon Richter Ltd. set out to automate the tank farm at its main manufacturing facility, the company sought out a vendor that offered not only process knowledge, but also compliance and validation awareness and ongoing performance assurance. | ||
| NIR and Imaging: Basic Principles and Pharmaceutical Applications | Gabriele Reich | 02/20/2006 |
| Published in Advanced Drug Delivery Reviews, this article by Gabriele Reich at the University of Heidelberg's Institute for Pharmaceutical and Molecular Biology examines the basics of NIR spectroscopy. | ||
| Using PAT for Crystallization and Drying | Zhihong Ge et al., Merck Research Laboratories | 01/24/2006 |
| In this article, Zhihong Ge and colleagues from Merck Research Labs discuss how they used PAT to monitor asymmetrical hydrogenation, crystallization and API drying. | ||
| The Drug Industry at a Crossroad: PAT's Role | Efraim Shek, Ph.D., Senior Vice President, Pharmaceutical Development, NeuroMolecular Pharmaceuticals, Inc. | 12/21/2005 |
| In this 6-page PDF document, author Efraim Shek asserts that PAT is part of a new paradigm whose time has come, and suggests how PAT can become more the rule than the exception. | ||
| Using PAT to Optimize Cell Culture for Monoclonal Antibody Development | Ache Stokelman et al., Amgen Inc. and BioProcessors Corp. | 12/05/2005 |
| Ache Stokelman and colleagues on Amgen’s Global Process Science Team outline how they used BioProcessors Corp.’s SimCell platform to improve results. | ||
| Aseptic PAT and Particle Monitoring — from Snapshots to Continuous Feedback | Mark Hallworth, pharmaceutical manager, Particle Measuring Systems | 11/22/2005 |
| Particle monitoring is critical for maintaining aseptic conditions, but portable counters won’t help develop trending data. In this white paper, Mark Hallworth, pharmaceutical manager for Particle Measuring Systems, discusses continuous monitoring methods, how they’re evolving, and why they’re important. | ||
| The Importance of Online Analysis in Solvent Recovery | Tim Wilkes, Servomex, Inc. | 10/31/2005 |
| As commercial and regulatory pressures increase, manufacturers look to maximize solvent recovery through online analysis. Tim Wilkes of Servomex, Inc. discusses the benefits. | ||
| Monitor Fermentation O2 and CO2 in Real Time | Tim Wilkes, Servomex, Inc. | 10/31/2005 |
| Keeping tabs on oxygen and carbon dioxide content in bioprocesses is critical for safety and contamination control, while comparing measurements against process models can help optimize yields and efficiencies, explains Tim Wilkes of Servomex, Inc. | ||
| Integrating APC and Six Sigma for Biopharma Manufacturing | Eyal Dassau, Israel Zadok and Daniel R. Lewin, PSE Research Group, Technion IIT | 08/30/2005 |
| Daniel Lewin and his team at Israel’s Technion International Institute of Technology are studying the impact of integrating APC with Six Sigma methodologies to manufacture biopharmaceuticals. The yield improvements they’re seeing may surprise you. | ||
| NIR-based PAT Replaces HPLC for Bottling | Uhlmann VisioTec | 08/30/2005 |
| This application note from Uhlmann VisioTec discusses NIR spectroscopy, offering some insights into how it was used to replace HPLC analysis at a pilot-scale pharmaceutical suspension bottling line. | ||
| Use of Atomic Force Microscopy to Accelerate Drug Development | J.Y. Zhu, Molecular Imaging Corp. | 08/25/2005 |
| This applications note discusses AFM and its potential in accelerating drug development. | ||
| How MES Enables PAT | Joseph Vinhais, RAC, Camstar Systems, Inc. | 07/29/2005 |
| A Manufacturing Execution System provides a framework for PAT, allowing for enhanced productivity and quality, says Joseph Vinhais, vice president of regulatory compliance at Camstar Systems. | ||
| Fluorescent Sensor Detects Microbes in Real Time | J.P. Jiang, Chief Technology Officer, BioVigilant | 07/07/2005 |
| BioVigilant is developing a commercial product that could monitor microbial presence in air and water, and could be modified to work in processes as well. In this article, inventor and optics specialist J.P. Jiang, Ph.D., discusses how the method works and the savings it offers over traditional methods. | ||
| The State of PAT in the Pharmaceutical Industry | Pavilion Technologies | 07/01/2005 |
| Pavilion Technologies’ recent survey of major manufacturers reveals divergent strategies between the U.S. and Europe, and mixed opinions about how broadly PAT should be defined. Quantitative and qualitative data are summarized here. | ||
| Using Online NIR to Empower Tablet Press Operation | Bruker Optics | 06/30/2005 |
| Near-infrared spectroscopy deftly handles on-line analysis of tablets — for uniformity, for example. This Bruker Optics paper discusses incorporating FT-NIR into tablet press operations. | ||
| Raman 101: A Primer for In-Situ PAT | Kaiser Optical Systems | 06/30/2005 |
| For in-situ PAT, Raman spectroscopy has advantages over Near-IR and Mid-IR. This technical note by Kaiser Optical Systems discusses Raman’s suitability for PAT applications and lists specific application opportunities. | ||
| Engineering Standards Advance Pharmaceutical PAT | Manuel Hormaza, CEO, IBS Caribe | 06/02/2005 |
| Manuel Hormaza, CEO of IBS Caribe, discusses process understanding and management, and the engineering standards that promise to bring plug-and-play capabilities to PAT. He also discusses PAT efforts in Puerto Rico, and the growing importance of local Technical Service Teams in the PAT effort, highlighting Upjohn’s experience. | ||
| Taming the Data Monster: Practical Guidance on Implementing PAT | Automsoft | 04/29/2005 |
| A new applications document from Automsoft summarizes the IT requirements for PAT, focusing on data management issues. | ||
| Design Tips for Selecting Sensing Probes | Delta Controls | 04/12/2005 |
| This application note from Delta Controls outlines selection and installation criteria for using admittance probes to monitor the level of powders, liquids and other materials. Dielectric constants of more than 200 materials are included. | ||
| Control Particle Size, Polymorphic Form and Blending | SSCI Inc. | 02/24/2005 |
| This applications note by the contract research firm SSCI Inc. provides an overview on how PAT can be used in pharmaceutical solids processing. | ||
| Optimize Bioreactor Design with PAT | Ingrid Maes, engineering specialist, Siemens | 02/24/2005 |
| This article outlines how PAT can be used to monitor bioreactors, and how this real-time monitoring was achieved by integrating advanced process control tools into the Simatic PCS 7. | ||
| Test-Drive a Chemometrics Training Video | Spectroscopic Solutions, LLC | 02/10/2005 |
| Spectroscopic Solutions, LLC has released a series of chemometrics training videos. Topics such as principal components analysis (PCA), multiple linear regression (MLR), and partial least squares (PLS) are covered in detail with real-world examples. | ||
| Application Note: Control of Fermentation Processes | Ametek Process Instruments | 01/26/2005 |
| This application note from Ametek Process Instruments discusses traditional approaches to fermentation process control, and how the company's process mass spectrometer can be effectively applied. | ||
| Qualifying a NIR Spectrometer to Meet 21 CFR Part 11 | Frederick H. Long, principal, Spectroscopic Solutions | 01/26/2005 |
| Clear goals and an early FAT prevented scope creep when at at-line NIR system needed to be validated for coating a pharmaceutical patch. Frederick H. Long, principal of Spectroscopic Solutions, outlines the secrets to this project's success in this 4-page PDF. | ||
| Level Measurement of Bulk Solids and Powders | Monitor Technologies | 01/19/2005 |
| This 26-page white paper (PDF format) from Monitor Technologies discusses the difficulties in measuring bulk solids and powders in bins, silos and hoppers. | ||
| The Business Case for PAT | Rockwell Automation | 11/24/2004 |
| Having trouble justifying PAT projects to top management? The business drivers for PAT are compelling, both on the regulatory and on the financial side. This Rockwell Automation white paper discusses how to conduct a “productivity improvement appraisal” and how to handle discovery and analysis phases of any PAT project. | ||
| Trade Shows are Good for You | 11/18/2004 | |
| Advances in Large-Scale Biopharmaceutical Manufacturing: Introduction | 10/22/2004 | |
| Pharma 2010: Silicon Reality | IBM Business Consulting | 10/22/2004 |
| If the pharmaceutical industry is to capitalize on its greater understanding of molecular science and disease, it will have to invest in the right tools. This forward-looking report, part of the Pharma 2010 series by IBM Business Consulting, details seven key emerging technologies, from predictive biosimulation to advanced storage solutions, that will drive life sciences innovation in the next decade. | ||
| Advances in Large-Scale Biopharmaceutical Manufacturing: Contents and Foreword | 10/22/2004 | |
| Standards for Pharmaceutical Applications of PAT | Don Marlowe, FDA Standards Coordinator, Office of the Commissioner | 10/20/2004 |
| This presentation by Don Marlowe, FDA Standards Coordinator in the Office of the Commissioner, outlines the ASTM E-55 Committee's efforts in developing PAT standards for pharmaceutical applications. | ||
| Design of Membrane Filtration Systems for Biotechnology Process Applications | 10/19/2004 | |
| Factors Affecting the Accuracy and Reproducibility of Gradient Formation for Preparative LC | GE Healthcare/Amersham Biosciences | 10/15/2004 |
| This Amersham Biosciences/GE Healthcare paper examines the impact of various factors — temperature, composition and delivery method of stock buffers and solvents — on gradient performance in preparative liquid chromatography. | ||
| Assessing Magnesium Stearate's Effect on Blends | 10/15/2004 | |
| PAT Answers: FDA's Final Guidance | U.S. Food and Drug Administration | 10/14/2004 |
| FDA recently released its final guidance on process analytical technology, “PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance," as part of its broader 21st Century cGMP initiative. | ||
| Technology Expands Flowmeter Capabilities, Reduces Costs | 10/13/2004 | |
| Capacitance-type magnetic flowmeters have traditionally offered the advantage of having non-wetted electrodes and the ability to measure low conductivity fluids. However, they suffered from a sensitivity to flow noise and zero instability. Innovative technology overcomes these limitations and drives magnetic flowmeters into new areas of application, while reducing installed costs. | ||
| InSight Vision Sensors and 21CFR Part 11 | 07/16/2004 | |
| Applying PAT to Crystallization | Lawrence X. Yu, Robert A. Lionberger, Andre S. Rawa, Rosario D'Costa, Huiquan Wu and Ajaz S. Hussain, FDA/CDER | 07/16/2004 |
| Crystallization processes pose challenges to manufacturers who seek to apply process analytical technologies (PAT), but progress is being made. This paper, from FDA's Center for Drug Evaluation and Research, discusses the challenges and provides some examples of how they're being addressed. | ||
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