Issue: Volume 68, Number 1 / 2025 Issue
Microbial Control of Product-Contact Surfaces for Non-Sterile Drug Manufacturing Equipment
Antonio Oritz
Limited regulatory guidance is available for bioburden levels on product-contact surfaces in nonsterile manufacturing environments. Cleaning procedures that address both product residues and microbial contamination ensure effective contamination control on product-contact surfaces for non-sterile drug manufacturing equipment.
Disassembly and Cleaning of a 10-ft Thermal Vacuum Chamber
Jeffrey Sayler, Alyse Turner, Hattie Rice, Wyatt Zagorec-Marks, Matt Triplett, and Kush Tyagi
“Jimmy” is the Laboratory for Atmospheric and Space Physics’ (LASP’s) largest thermal vacuum (TVAC) test chamber, a cylinder 4.0 m (13 ft) long with a 3.0 m (10 ft) interior diameter. It is primarily used for TVAC tests of spacecraft and large instruments. The chamber was contaminated in 2019 during a multilayer insulation (MLI) bakeout. To remedy the contamination, a plan was developed along with University of Colorado Boulder Environmental Health & Safety (EH&S) to safely disassemble and clean the chamber.
The USAF Research Laboratory’s SCEPTRE Facility
Jessica M. Hendricks, Clifford A. Cerbus, Mark A. Walker, and Joseph P. Costantino
Actual spaceflight experiments designed to evaluate a spacecraft material’s performance are very costly and have only been performed on extremely limited occasions for geosynchronous Earth orbits (GEOs) and medium Earth orbits (MEOs). A judicious approach designed to provide a representative environment by combining a subset of the essential elements, synergistically or serially (or with both approaches combined), can be used to target specific performance parameters of a spacecraft material. The Air Force Research Laboratory Materials and Manufacturing Directorate’s (AFRL/RX’s) SCEPTRE (Space Combined Effects Phenomenology Test and Research Experiments) Facility is a laboratory that employs such an approach.
Reliability and Mission Engineering: Improving Mission Success
Dr. Justin Brown
Mission engineering (ME) and reliability engineering are systems engineering disciplines used throughout product development and sustainment of a system. This paper highlights the commonalities and differences between these two disciplines. ME generally lacks standardization and precision of analysis due to less guidance documentation, uncertainty, and data limitations. Reliability analysis can improve the results of ME analysis and thus, should be embedded within ME.
Issue: Volume 67, Number 1 / 2024 Issue
The Next Chapter in the History of International Cleanroom Standards
Richard A. Matthews and Anne Marie Dixon-Heathman
Key Elements of a Successful Cleaning and Disinfection Program
James N. Polarine and Anne Marie Dixon-Heathman
ISO Technical Report 14644-21 Published to Support ISO 14644 Parts 1 and 2
John Hargreaves and Andrew Watson
Issue: Volume 66, Number 1 / 2023 Issue
Progression of Cleanroom Standards Development, 1959-1970s
Clifford "Bud" Frith
New Standard on Macro-Particles and Visible Particles in Cleanrooms—ISO 14644-17, Particle deposition rate applications
Koos Agricola
Issue: Volume 65, Number 1 / 2022 Issue
Considerations Toward Optimal, Meaningful Sample Collection and Data Evaluation in Pharmaceutical Environmental Monitoring Programs
Omar Cruz Martinez
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