Issue: Volume 65, Number 1 / 2022 Issue
Considerations Toward Optimal, Meaningful Sample Collection and Data Evaluation in Pharmaceutical Environmental Monitoring Programs
Omar Cruz Martinez
Environmental Monitoring (EM) programs often become overburdened with sampling locations derived from fulfillment of the minimum sampling locations required by regulatory compendial. Often, EM programs are not properly reevaluated resulting in 1) missed opportunities to optimize the programs, and 2) perpetuation of sampling locations that do not provide certainty about the existing environmental conditions in the pharmaceutical manufacturing areas. This burden can become more acute based on information obtained during routine monitoring during the surveillance stage and confirmed by a formal risk assessment.
The selection of meaningful sampling locations should provide meaningful data to allow the owner to evaluate the adequacy of the contamination control program to maintain the current balance and interaction between any given contamination source, the intended manufacturing environment, and the existing contamination control program. Combining these three elements will determine the feasibility of a manufacturing process within the intended grades of confidence defined in a regulatory document.
Issue: Volume 64, Number 1 / 2021 Issue
Update of ISO Technical Committee 209 Cleanrooms and Associated Controlled Environments
David Ensor, Robert Mielke, Jennifer Sklena
Issue: Volume 63, Number 1 / 2020 Issue
Energy Efficiency in Cleanrooms and Separative Devices: ISO 14644-16, Outreach Article
Richard Gibbons
Issue: Volume 62, Number 1 / 2019 Issue
Monitoring of Nanoscale Particles in Cleanrooms: ISO 14644-12
Anne Marie Dixon-Heathman, David Ensor
Issue: Volume 61, Number 1 / December 2018 Issue
Journal of the IEST Marks 60th Anniversary
Roberta Burrows
ISO/TC 209 Tackles Revisions of ISO 14644 Standards
Roberta Burrows, David Ensor, Jennifer Sklena
Is There a Ticking Dust Bomb in Your Cleanroom?
Roger Diener and Morgan Polen
Assessment of Cleanroom Suitability of Equipment and Materials by Chemical Concentration—ISO Standard Now Available for Designers, Suppliers, and Users
Berthold Düthorn
Issue: Volume 60, Number 1 / December 2017
ISO/TC 209 Launches New Cleanroom Standards and Outreach Projects
Roberta Burrows, David S. Ensor
Beyond the ISO Cleanroom Standards—Comprehensive Guidance from IEST
Roberta Burrows, Anne Marie Dixon-Heathman
Issue: Volume 59, Number 1 / November 2016
IEST Leads Development of First ISO 14644 Nanotechnology Standard
David S. Ensor, Anne Marie Dixon, Roberta Burrows
Issue: Volume 57, Number 1 / October 2014
ISO Technical Committee on Cleanrooms and Associated Controlled Environments
Enters Third Decade with New Changes on Horizon
David S. Ensor
Issue: Volume 56, Number 1 / March 2013
IEST and UGIM Working Together
John R. Weaver
Case Study: Design and Construction of the Draper Laboratory Microfabrication Center
Richard H. Morrison, Livia M. Racz, David J. Carter
Facilities Planning for Safety and Emergency Response: Bridging the Gap between Design Features and Safety Planning
Steve Schultz, Jack Paul
Financial and Operational Survey of 12 Major University Nanofabrication Facilities: A Benchmarking Study
Dennis Grimard, Lisa Jones
Retrospective: Historical Highlights of an Evolving Society
Willis J. Whitfield: Father of the Modern Cleanroom
Issue: Volume 53, Number 2 / October 2010
The Clothes Truly Did Make This Man
Heidi Parsons
Mitigating the Risk of Counterfeit Parts
Reprinted from WSTIAC Quarterly; based on a report by the Government Accounting Office
Issue: Volume 53, Number 1 / April 2010
Facts and Fiction in Cleanroom Metrology
Lothar Gail, Dirk Stanischewski
Issue: Volume 52, Number 1 / April 2009
Cornerstone Cleanroom Standards Under Revision
TWR, Multi-exciter Testing Added to New Revision MIL-STD-810G
Evaluating Clean-Air Devices
Issue: Volume 51, Number 2 / October 2008
IEST leads ISO 14644 Experts in Focus on Nanotechnology in Cleanrooms
Anne Marie Dixon, David Ensor, Roberta Burrows
Nanotech Facility Hosts ESTECH Tour
Issue: Volume 51, Number 1 / April 2008
Forging New Frontiers
Diana Granitto, Senior Editor
IEST Updates Recommended Practices to Reflect Leading-edge Methods
An In-Depth Assessment of Internal Contamination in the Wide Field/Planetary Camera: Republished from the Journal of the IEST May-June 1990 issue
Carl Maag, Jerry Millard, Mark Anderson
Issue: Volume 50, Number 2 / October 2007
New ISO Draft Standard Classifies Surface Particle Cleanliness
New Reliability Prediction Methodology Incorporates Field and Test Experience
David Nicholls
Issue: Volume 50, Number 1 / April 2007
Updated IEST-RP-CC012 a "Must Read" for Cleanroom Planners and Designers
ISO 14644-5 Offers a One-stop Guide to Cleanroom Operations
Anne Marie Dixon
Industry Responds to Proposed Changes to USP Sterile Compounding Rules