November / December 2011

November / December 2011 Cover


Applying Predictive Maintenance Techniques to Utility Systems
by Padraig Liggan and David Lyons
This article discusses how Predictive Maintenance (PdM) technologies can be successfully applied to both GMP and non-GMP utility systems in the pharmaceutical industry. The discussion also demonstrates the clear benefits of PdM, including the use of a proactive approach to maintenance.

Online Rouge Monitoring: A Science-Based Technology to Measure Rouge RatesĀ 
by Nissan Cohen and Allan Perkins
This article presents the implementation and installation of an online rouge monitor which measures in near real-time the rouge rate and rouge accumulation (metal loss) over time helping to determine derouging and passivation frequency based on empirical data.

Determining Acceptable Levels of Weld Discoloration on Mechanically Polished and Electropolished Stainless Steel Surfaces
by Ken Kimbrel
This article will identify acceptable levels of weld discoloration on mechanically polished and electropolished stainless steel surfaces and also show proven shop and field remediation practices to removes excessive heat tint. Additionally, we will show the effect of various oxygen levels and the impact heat tint has on corrosion resistance. The information herein is based on actual field experiences and successful methods of field remediation.

Engineering and Design Considerations for Thermal Inactivation of Bio-Hazardous Waste Streams
by Juha Mattila
This article presents important considerations when designing thermal inactivation systems for bio-hazardous applications, and provides a comparison between properties of batch and continuous decontamination systems.

Survey of Pharmaceutical Water System Users on the Use of Non-Distillation Systems for the Production of WFI
by Dr. Anthony Bevilacqua and Dr. Teri C. Soli
This article presents the results of a jointly sponsored USP/ISPE survey of the pharmaceutical industry and analyzes the potential to use alternative methods of production (other than distillation) as the final purification in the preparation of Water for Injection (WFI).

Industry Interview Series: Efraim Cohen-Arazi, CEO and Co-Founder, Rainbow Medical
by Nissan Cohen
Efraim Cohen-Arazi discusses the business side of the life sciences industry. He offers a look into the R&D and investment strategy of his own venture investment firm, Rainbow Medical.

Alternative Test Methodology for In-Situ Testing of ePTFE HEPA Filters for Pharmaceutical Applications
by Eugene Bryan, Bill Kitch, Jim Meek, Dan Milholland, and Nathaniel Nance
This article presents the study results of using an ultra low poly-alpha-olefin (PAO) challenge and a particle counter to preform leak sizing on an expanded polytetra- fluoroethylene (ePTFE) filter.

Understanding Operational Waste from a Lean Biopharmaceutical Perspective
by Richard Benson and Niranjan S. Kulkarni
This article presents different types of operational wastes (non-value adding activities), provides examples of wastes common to pharmaceutical and biotech manufacturing, and lists commonly used techniques to analyze and reduce waste.

Cleaning Validation for the 21st Century: Overview of the New ISPE Cleaning Guide
by Andrew Walsh
This article provides an overview of an ISPE Cleaning Guide currently under development. The Guide will provide a framework for a scientific, risk-based approach to cleaning processes and validation.