Volume 22, Number 6

Table of Contents

Articles

A Prescription for Chemical Management: Beyond Compliance in 2002

by Mark Wysong
In the pharmaceutical manufacturing environment where competitive strategies focus heavily on production, quality and safety, this article addresses the daunting task of effectively maintaining and efficiently accessing MSDS to help improve bottom-line profitability.

Perm-Selective Chitosan-Alginate Microcapsules for Enzyme Immobilization Technology

by Ehab Taqieddin, Mansoor Amiji, Carolyn Lee
This article discusses how hybrid double-layered microcapsules composed of calcium-cross-linked alginate core coated with chitosan were made. Enzyme loading and activity studies were preformed and enzyme was shown to retain activity after loading into the final microcapsule system.

The Effect of Thermal Cycling on Seals in Ball Valves and Clamp-Type Fittings

by Dave Simko
This article discusses the effect of thermal cycling on the stem seal and seats in ball valves, used extensively in utility systems, and the seal sanitary clamp-type fittings used throughout both the process and the utility systems.

Maintenance Management - A Process Approach

by G.B. Rao, V. Anatha Narayan
This article describes a process approach for maintenance management as envisaged by ISO 9000-2000 quality management systems.

Total Quality Management in Pharmaceutical Plant Construction

by Dean Poillucci
Project quality begins in the early planning stages of the project and requires collaboration from all project stakeholders.

An Interview with Craig Muir

by Craig Muir
A leader in the Biopharmaceutical Industry discusses his company’s growth, products in the pipeline, alliances with other organizations, and improving productivity in the future.

Using New Cleanroom Standards with Sterile GMPs

by Gordon Farquharson
Gordon Farquharson explores the symbolic relationship between current GMP and the new ISO cleanroom standards with regards to sterile products processing.

Computerized Automation: from Process Control to Validation

by Carlos Bestetti
How a cooperative approach to validate benefits both suppliers and users in an environment where regulatory inspections are focused on computerized/automated systems.

Effective Cost Control for Automated Systems Validation Projects and Procedures

by John Andrews
This article presents an approach to Rick Assessment as a means of reducing the cost of validation, while maximizing the benefits.

Change Management in the Pharmaceutical Industry

by John Tuttle, Janet Buecker
The article describes a system for managing change from a pharmaceutical supplier’s perspective.

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