Technical Article Archive

Hot Picks

Transferring a Genetically Engineered Biopharmaceutical from Research to Clinical Development - Impact on Facility Design and Build Projects
Declan Greally and Rodger Edwards
Pharmaceutical Engineering, Vol. 22, No. 4, pp 35-46.

From the ISPE Boston Area Chapter Newsletter

June 2008
Value Proposition - I/O Simulation & Testing
by Eric Bird

April 2008
Nanotechnology: A Key Trend in the Pharmaceutical and Biotech Industries
by Martin E. Rock, P.E., J.D.

February 2008
The Challenges in Integrating a Process Control System with Skid-based Equipment: A Case Study
by Robert Patrick

Optimizing Your Steaming Operation: A Steam-In-Place Primer
by Pietro Perrone

December 2007
Troubled Projects - Part II: Execution Performance Factors
by Rob Cimini

October 2007
Troubled Projects – Part I: The Design Factors
by Rob Cimini

August 2007
Process Analytical Technologies (PAT) and Non-viable Particle Counting
by Mark Hallworth

June 2007
Use of Hydrogen Peroxide Vapor (HPV) for Decontamination of Virally Infected Areas
by Ron Dattoli (Wyeth, Cambridge, MA) with assistance from Adam Warner (BIOQUELL, Inc.)

December 2006
Optimizing Pump Operation-A Simple Solution
by Larry Bachus, edited by Pietro Perrone

October 2006
A Biopharmaceutical Vessel- A World of its Own
by Pietro Perrone

August 2006
Nanomaterials for Drug Delivery: Potential Benefits and Risks
by Brenda E. Barry and JoAnne Shatkin

April 2006
Consider C/M Partnering Agreements to Improve Value, Quality
by Kevin Brettmann 

February 2006
Cleaning In Place
by Pietro Perrone

February 2005
Environmental Monitoring-Viable Particles: A Primer
by Fran McAteer and Jim Barbato

December 2004
Using Your Nose
by Ben Wilbert

October 2004
CIP: Use of Acid-Blend Detergents and the Avoidance of Foam
by Jim Watson

June 2004
Standard Goes Live for Life Sciences: A new approach to navigating regulatory requirements
by Glenn Restivo

April 2004
Corrosion and Extraction Analysis of Teflon PFA in Comparison to Corrosion Resistant Metal Alloys
by Lauri Jenkins, Victor Lusvardi, and Sharon Libert

March 2004
Data Requirements for a Successful Study Effort leading to Performance Improvements
by Lew Gordon, Invensy plc

February 2004
Process Piping Documentation for Pharmaceutical and Biotech Applications
by Tim Paulding, GMP Systems Inc.

Rouging in Stainless Steel Equipment
by Richard E. Avery; edited by Pietro Perrone

November 2003
Disposable Technologies

Extractables Analysis With No Substitutions
by Patricia Stancati, Sartorius

Improvements in Viscosity Testing for Quality Control
by Len Thibodeau, Brookfield Engineering Laboratories, Inc.

October 2003
Troubleshooting Guide; Topic: Poor Mammalian Cell Growth
Michael Mietzner, IPT

September 2001
Process Validation of Existing Processes and Systems Using Statistically Significant Retrospective Analysis - Part Three of Three
Andrew W. Jones

April 2001
Process Validation of Existing Processes and Systems Using Statistically Significant Retrospective Analysis - Part Two of Three
by Andrew W. Jones

January 2001
Process Validation of Existing Processes and Systems Using Statistically Significant Retrospective Analysis - Part One of Three
by Andrew W. Jones

October 2000
Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing
Karen A. Clark

April 2000
Fundamentals of Water Purification (Part Two of Two)
Brian Hagopian, CIPE

January 2000
Fundamentals of Water Purification (Part One of Two)
Brian Hagopian, CIPE

November 1999
IQ Validation Test Procedure
Jon R. Voss

February 1999
Cleaning Validation Acceptance Criterion - Case Study
Jon R. Voss

September 1999
CIP/COP Validation Test Procedure
Jon R. Voss

May 1999
End User Validation Requirements for COTS Software
Mark Matis

December 1998
Responding to 483s and Warning Letters
David L. Chesney and Anne E. Kelly

September 1998
The Sturtevant Sanitary Design Micronizer Still the Only USDA-Dairy-Accepted Jet Mill

January 1997
Cleaning Verification Case Studies
David DeLucia

September 1996
Maximizing Productivity Around the Clock
Nicholas M. Murphy