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Topic: Unit Operations
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Management of Change: Every Plant for Itself!
Grasping Lyophilization Product and Process Parameters for Biopharma
Stability Testing Meets QbD
Cause for Alarm? |
White Papers: In depth research
| Title | Author | Date |
| AstraZeneca Decided for Paperless Solution | Anders Anlind | 08/22/2006 |
| AstraZeneca opted for a paperless solution that would allow for data trending and a centralized, accessible calibration data base. It is cost effective. | ||
| 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. | ||
| Process Modeling and Control Challenges in the Pharmaceutical Industry | Phil Dell'Orco, GlaxoSmithKline | 02/24/2006 |
| In this 2003 presentation made at a conference held by the University of Texas, Phil Dell'Orco, GSK's Leader for Process Safety and Design, summarized the challenges facing engineers as they work to improve control of pharmaceutical processes in an industry still dominated by chemists. | ||
| Best Practices for Materials Handling for Primary and Secondary Pharmaceuticals | GEA Pharma Systems | 02/20/2006 |
| This 8-page paper by GEA Pharma Systems provides a timeless summary of specifications and selection criteria, with regard to materials handling and containment. | ||
| Phase Transformation in Solid Pharmaceutical Materials | Denny Mahlin, Uppsala Faculty of Pharmacy | 02/20/2006 |
| This 72-page PDF, a dissertation by Denny Mahlin at Sweden's Uppsala Faculty of Pharmacy, discusses results of using atomic force microscopy and other techniques to study solid mixtures for solid dosage forms. | ||
| Cellulosic Esters: Compression Behavior and Film Coating Properties | Hong Xia Guo, Helsinki University | 02/20/2006 |
| This 48-page thesis by Hong Xia Guo at Helsinki University looks at the impact of compression and the enteric coating properties of cellulose esters. | ||
| Aqueous Film Coating of Tablets in a Side-Vented Pan Coater | Mirja Ruotsalainen, Helsinki University | 02/20/2006 |
| This 53-page thesis by Mirja Ruotsalainen at Helsinki University, Finland, examines the impact of coating and storage on surface morphology, moisture control and stability. | ||
| 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. | ||
| The Next Wave in Disposable Mixing | Wave Biotech | 10/18/2005 |
| Disposable mixers have expanded their repertoire and can now handle high-viscosity solid/liquid mixing. Wave Biotech maps out the throwaway future. | ||
| Maximizing the Benefits of PEGylation by Optimizing the Conjugation Process | Guus Scheefhals, VP of Business Development, Avantium Technologies | 06/22/2005 |
| PEGylation can improve product yields, adding significant value. | ||
| Use CFD to Improve Crystallization | Fluent, Inc. | 05/16/2005 |
| Drug manufacturers charged with developing, scaling up or scaling down any process involving crystallization face major challenges, given the industry's current understanding of flow characteristics and crystallization kinetics. In this article, Kumar Dhanasekharan, Ph.D., technical specialist with the computational fluid dynamics (CFD) specialist Fluent, Inc., shows how modelling crystallizers using CFD can help improve process understanding, control crystal size distribution (CSD) and improve pharmaceutical crystallization results. | ||
| Plastic Towers Help Manufacturers Keep Their Cool | Delta Plastics | 05/12/2005 |
| Plastic cooling towers are increasingly replacing metal towers in many industries. This paper is designed to help engineers understand how plastic towers' durability is helping reduce maintenance costs and avoid costly interruption due to tower failure. | ||
| Preventing Segregation During Powder Drying | Jeroen van den Berg, Bolz-Summix | 04/29/2005 |
| This 4-page case history by Jeroen van den Berg of Bolz-Summix discusses how changing process conditions within a conical screw dryer eliminated granulation and minimized product segregation. | ||
| Clean in Place Operations for Thin-Cake Filtration Operations | BHS-Filtration | 04/29/2005 |
| In many chemical and pharmaceutical processes, solid-liquid separation, cake washing and drying steps directly impact the effectiveness of the production operation. In solid-liquid separation, there is a choice both of the type of filter media and the thickness of the cake or the cake depth during which the separation occurs. This article by Barry A. Perlmutter, President of BHS-Filtration, discusses the choice of thin-cake (2 – 25 mm) separation technologies and outlines best practices for implementing clean-in-place operations and associated control systems. | ||
| Applications Note on Multipurpose Peeler Centrifuges | Riera Nadeu U.S.A. | 04/29/2005 |
| The latest generation of multipurpose GMP-compliant peeler centrifuges have been designed to ease batch changes, prevent contamination, and improve separation. This applications note from Riera Nadeu U.S.A. discusses considerations for specifying, cleaning and using this type of equipment. | ||
| Recovering Precious Metals from Spent Catalysts | Sabin Metals | 02/03/2005 |
| Looking for a new revenue stream? Recycling catalysts is easy and profitable — and so overlooked — as Sabin Metals explains. | ||
| 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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