Conference sessions are comprised of technical papers, panels, and case studies on the latest issues impacting the industry. Get the most up-to-date information from leading industry experts in your fields. 

 Program subject to change. More session presentations will be added below as they are approved.

Tuesday, May 9, 2023

Environmental Monitoring: Outgassing, Films/Coatings, and Nanoparticles
9:30 a.m. - 11:20 a.m. Central Time
Chair: Ziva Abraham, Microrite

Presentations:

• Detecting Aerosol Events Caused by Nanoparticles - Mike Turnure, TSI
• Biofilm and Biofilm Remediation - Dan Klein, STERIS
• Lessons Learned from Designing and Building Low Organic Outgassing Cleanrooms from NASA OSIRIS-REX and HAYABUSA2 Curation Facilitiy - Jeffrey McQuillan - Jacobs at NASA Johnson Space Center

Critical Environments in Advanced Nanoscale and Quantum Research Facilities
1 - 2:50 p.m. Central Time
Chair: Ahmad Soueid, HDR Architecture, Inc.

The nanotechnology program as IEST leverages the society’s well established and preeminent industry role in the areas of contamination control; design, test, and evaluation; and product reliability. IEST has taken many positive steps in addressing the challenges and considerations in planning facilities requiring critical environments by providing a focus on the IEST-RP-NANO program.  IEST-RP-NANO200 and NANO205 focused on planning and guidelines for Design, Construction, and Start-up as well as safety by applying prevention through design principles to nanotechnology facilities.  The soon to be released IEST-RP-NANO201 and NANO202 will focus on Measuring and Reporting Vibrations in Advanced Technology Facilities and Testing Aerosol-Nanomaterial Containment Devices.  

One of the objectives of the IEST-RP-NANO program is to develop Recommended Practices for categories of contamination best characterized as “energy contaminants” — specifically, vibration, acoustics, temperature stability, and electromagnetic effects, added to the already existing RP’s associated with electrostatic discharge (ESD), particulate contaminants and molecular contaminants. Energy contaminants affecting critical environments in advanced research and development facilities provide many challenges to facilities designers, builders and operators alike.  Due to the diversity of these contaminants and how they affect facilities dealing with emerging technologies, the industry lacks consensus regarding format, signal processing and units associated with assessment of these contaminants.  This conference session focuses on critical environments and how industry leaders solve these challenges.  

Presentations:

• Evolution of Energy-Contaminant Criteria: Convergence or Divergence? - Hal Amick and Steven Lank, Colin Gordon Associates
• Translating Statistical Data from Vibration Surveys: Subtleties and Opportunities - Byron Davis, Vibrasure
• Critical Environments for Quantum Research: Stability is Key - Jack Paul, HDR Architecture
• Exploring Absolute Motion: Special Sensitivities in Quantum Research and a Very Long Laser Aiming System - Byron Davis, Vibrasure

Contamination Control in the Cannabis Industry
3:10 - 5 p.m. Central Time
Chair: Dijana Hadziselimovic, STERIS

Presentations:

• Best Practices for Ensuring Patient & Consumer Safety in Cannabis and Hemp Manufacturing: A Novel Approach for Cleaning and Disinfection - Dijana Hadziselimovic, STERIS
• Designing Processes to Mitigate Microbial Risk in Commercial Cannabis Manufacturing Facilities - Paul Lopolito, STERIS

Wednesday, May 10, 2023

Environmental Monitoring: Viable and Non-Viable Particulate Contamination, Except Nanoparticles
8 - 9:50 a.m. Central Time
Chair: Hasim Solmaz,Lighthouse Worldwide Solutions

Presentations:

• Advances in Cleanroom Environmental Monitoring and Control - Howard Abramowitz, Aircare Automation and Heath Throneberry, AJ Manufacturing
• A Clinical Application of Cleanroom Testing Principles to the Hospital Operating Room During Orthopedic Total Joint Replacements - Dr. John Harp, Baptist Health-Fort Smith, Orthopedics Clinic
• Bio-Fluorescent Particle Counting Technology: Applications of a Modern Microbial Method in Controlled Environments - Allison Scott, MicronView

Contamination Control in Controlled Environments
10:10 a.m. - 12 p.m. Central Time
Chair: Dave Nobile, Contec

• Applications of Process Intensification Factor and Cost Impact Factor in Optimizing Ultrasonic/Megasonic Cleaning Processes - Dr. Ramamurthy Nagarajan, IIT Madras
• History of Cleanroom Standards Development - Bud Frith, Consultant
• Cautionary Considerations for Tack Cloth and AMS3819 - John Lyman, J Lyman Industries, Inc.

• An Analysis of the Structure and Testing Methods of a Cleanroom Garment System Compliant with IEST-RP-CC052 - Tom Watkins, Transforming Technologies

Thursday, May 11, 2023

GMP Annex 1
8 - 9:50 a.m. Central Time
Chair: Jim Polarine, STERIS

Annex I was updated and finalized this year in August. This session will focus on several key aspects of Annex I which include developing a Contamination Control Strategy, Environmental Monitoring, Bioburden and Particle control in cleanrooms, RABS, and Isolators. One of the key focuses of Annex I is to remove operators from the aseptic area by utilizing RABS and isolator technologies. The new Annex I is a concerted effort to move the industry forward in contamination control, rapid methods, environmental monitoring, cleaning and disinfection as well as newer technologies for isolating and preventing contamination during aseptic production. There are several new updated sections of Annex I which cleanroom facilities will need to become complaint with by August 2023.

Presentations:

• EU GMP Annex 1 Changes and Impact to Sterilization of Product Contact Equipment - Renee Buthe, STERIS
• A Roadmap to a Successful Contamination Control Strategy (CCS):  Covering Annex I Updates and FDA Warning Letters and 483’s - Jim Polarine, STERIS
• Regulatory Audit Perspective of Cleanroom Disinfectant Qualification - Madison Hoal and Donald Singer, Ecolab Life Sciences

Cleanroom Microbiology
10:10 a.m. - 12 p.m. Central Time
Presenter: Ziva Abraham, Microrite

Microbiological control in medical products and medical products cleanrooms is a regulatory requirement to protect patients from harm. Understanding types of microbes, their sources, their methods of ingress, transport and proliferation within the cleanrooms and the challenges in disinfection and their clinical implications are some of the few ways to ensure microbiological contamination control.

Special Topics and Trends in the Industry
1 - 2:50 p.m.
Chair: Jim Polarine, STERIS

This session will focus on supply chain management, supply chain disruptions, the effects of the pandemic on labor shortages in the cleanroom industry, and business continuity. Contamination control and validation topics will also be included in this session. The special topics session will include presentations and topics that are cutting edge and not included in the other sessions this year at ESTECH.

Presentations:

• Integrating Cleanrooms with Roll-to-Roll Manufacturing: A Case Study - Donald Davis, KDI Technical Services
• Decontaminating HEPA Housings and Ductwork with Chlorine Dioxide Gas - Kevin Lorcheim, ClorDiSys Solutions, Inc

The New USP Chapter 797 
3:10 - 5 p.m. Central Time
Chair: Michael Myers, Contec

Presentations:

• Defining New Categories and BUDs - Mary Nazal, Critical Compounding Resources
• Cleaning and Disinfection - Michael Myers, Contec
• Hand Hygiene and Garbing/GFS Personnel Training - Mary Nazal, Critical Compounding Resources and Michael Myers, Contec
• Movement of Materials into the PEC and SEC - Michael Myers, Contec

To submit an abstract for one of the above topics, please click here.