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Topic: Aseptic Processing
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Disposables: Increasingly Indispensable
Optimizing Cleanliness & Drainability
Conductivity Measurement: Critical for Clean-In-Place Systems
A Synthesis of Cultures |
White Papers: In depth research
| Title | Author | Date |
| Environmental Testing : Deciphering Compliance Requirements for Pharmaceutical and Medical Device Manufacturers | Microtest Laboratories | 07/10/2007 |
| Industrial sterilization and contamination control programs are critical in pharmaceutical and medical device manufacturing. This article by Microtest Labs reviews the key elements of a best practice environmental testing program, including sterilization standards, FDA requirements, and the critical factors in maintaining controlled environments. In this paper, the author draws on his extensive experience assisting clients with program development. He reviews strategies that range from the essentials of compliance to budget development and management. | ||
| 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. | ||
| 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. | ||
| 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. | ||
| 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 Aqueous Cleaning Handbook (4th Ed.) | Alconox, Inc. | 06/28/2005 |
| This 99-page document from Alconox, Inc. is a comprehensive handbook on aqueous cleaning. | ||
| Cleanroom Monitoring: Real-time vs. Sequential | Lighthouse Worldwide Solutions | 05/18/2005 |
| Monitoring cleanrooms is the only way to ensure aseptic conditions. But there’s more than one way to do monitor particles. This white paper by Lighthouse Worldwide Solutions discusses when to use real time, and when to use sequential particle monitoring, and outlines the pros and cons of each approach. | ||
| Influenza Vaccine: Current Status, Lessons Learned and Preparing for the Future | U.S. Food and Drug Administration | 02/18/2005 |
| Dr. Jesse Goodman, director of FDA's Center for Biologics Evaluation and Research, testified Feb. 10, 2005, before the U.S. House of Representatives' Committee on Government Reform, regarding the present and future status of flu vaccine supply and demand. Access the 6-page transcript here. | ||
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