January/February 2003
Volume 23, Number 1

Theme: Vaccines

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. Download Article...

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. Download Article...

Blinding Clinical Supplies Utilizing Overencapsulation by Robert G. Myers & Colleen M. Cratty The blinding of solid dosage units for use in clinical supplies. Download Article...

Enhanced Design Review/Design Qualification by Robert E. Chew, PE This article describes how to conduct design qualification and the benefits of performing EDR/DQ. Download Article...

Human Insulin Interaction with Soybean Powder by Antoine Al-Achi, Thomas J. Clark, III, 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. Download Article...

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. Download Article...

Country Profile: Ireland by ISPE Ireland Affiliate This section takes a look at the pharmaceutical industry in Ireland; produced in collaboration with ISPE Ireland. Download Article...