Volume 23, Number 1

Table of Contents

Articles

The ANSI ISA S88.01 Standard: A Case Study of its Application in the Pharmaceutical Industry

by M. Mangiarotti, M. Rizzi
A modular management production system based on the ANSI ISA S88.01 standard provides a comparison of Equipment Module and Control Module Options.

Manufacturing and Quality Partnership in Support of Product Development

by Frank S. Kohn, Carmen Wagner
This article focuses on one aspect of product development teamwork, namely the partnership between quality and manufacturing.

Blinding Clinical Supplies Utilizing Overencapsulation

by Robert G. Myers, Colleen M. Cratty
The blinding of solid dosage units for use in clinical supplies.

Enhanced Design Review/Design Qualification

by Robert E. Chew
This article describes how to conduct design qualification and the benefits of performing EDR/DQ.

Human Insulin Interaction with Soybean Powder

by Antoine Al-Achi, Thomas J. Clark, Robert Greenwood, Shylock Sipho Mafu
The mode of interaction of human insulin with soybean powder, a potential carrier system, may be described as adsorption associated with weak bonding forces.

Incubator Design for Optimal Heat Transfer and Temperature Control in Plastic Bioreactors

by William Adams, Kim Dezura, Sara Diffenbach, Charles Goochee, Colette Ranucci, Scott Reynolds, Abraham Shamir
This article describes how a model was developed to describe the thermal response of large plastic bioreactors in incubators with variable air speed, and then used to provide a general guide for incubator design.

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