November / December 2013 Cover


Cleaning Validation for the 21st Century: Acceptance Limits for Cleaning Agents
by Andrew Walsh, MS, Mohammad Ovais, MP, Thomas Altmann, Gr FC, and Edward V. Sargent, PhD
This article presents currently suggested approaches to setting acceptance limits for cleaning agents, some of the difficulties with these approaches, emphasizing the need to move to a health-based approach as was suggested for APIs.

Risk Assessment for Cross-Contamination in Solid Dosage Form Manufacturing Facilities
by Mock FMEA Special Interest Group (SIG), Containment COP, and ISPE Japan Affiliate
This article presents a risk evaluation method and case studies using Failure Mode and Effects Analysis (FMEA) introduced in ICH Q9 to establish cost-effective countermeasures for cross-contamination in solid dosage form manufacturing facilities.

Master Planning the Legacy: Meeting Good Manufacturing Practices While Using Existing Pharmaceutical Manufacturing Facilities
by Eric Bohn, AIA
This article explores some of the challenges and opportunities that can be encountered when bringing legacy facilities into compliance with current good manufacturing practices.

The Efficacy of Ozonated Water in Biofilm Control in USP Purified Water Circulation and Storage
by Erika Hanley-Onken and Nissan Cohen
This article presents a case study for the use of ozone to reduce the amount of biofilm contaminant in a pilot UPW production and delivery system designed to represent typical large 316L stainless steel systems in biopharmaceutical companies.

Cleaning Validation: A Timely Solution for Improving Quality and Containing Cost
by Christopher Crone
This article presents an economic case for the use of on-line Total Organic Carbon (TOC) and conductivity analysis for validating automated CIP cycles with two separate case studies.

Steam Sterilization Principles
by Marcel Dion and Wayne Parker
This article presents how a good understanding of basic steam sterilization principles can help with avoiding most common mistakes made when using steam autoclaves.

Comparing Energy Consumption of RABS and Isolator Configurations
by Benjamin Hoffman, Katarzyna Frank, and Johannes Rauschnabel
This article presents a comparison of energy consumption of the ventilation and air conditioning system for a passive RABS, an active RABS, and an isolator system, including the different clean room requirements.

The Application of Cogeneration for Pharmaceutical Facilities
by Joseph F. Masiello, PE CEM LEED AP
This article presents how the pharmaceutical industry has various unique characteristics, along with the various issues of concern for those in the industry contemplating the use of cogeneration.

A Practical Approach to Managing Knowledge – A Case Study of the Evolution of Knowledge Management (KM) at Merck
by Marty Lipa, Samantha Bruno, Michael Thien, ScD, and Robert Guenard, PhD
This case study presents the development of a knowledge management program, including the creation of a strategy, a suite of capabilities and model for sustaining the flow of knowledge, and establishing and maintaining the connection to improved business outcomes.

Diaphragm Valve Development – Challenging Traditional Thinking
by Per-Åke Ohlsson
This article presents the shortcomings of the traditional diaphragm and demonstrates how changes in the new generation diaphragm valve can reduce maintenance costs, minimize the risk of contamination, reduce pressure drop, and provide better flow regulation.

In This Issue