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.

Monday, May 6, 2024


Molecular AMC/SMC
1:15 - 3:05 p.m.
Chair: Victor Chia, Balazs NanoAnalysis

Airborne molecular contamination (AMC) is a significant contributor to the loss of yield in semiconductor processes and affects many other industries, including pharmaceutical, optical, medical, aerospace and defense. The impact of AMC becomes prominent when AMC forms surface molecular contamination (SMC) on critical components and production surfaces. This session invites contributions to how AMC is formed, and how we can control, monitor, and reduce AMC and SMC. Join this session to meet colleagues who encounter the same challenges as you and expand your contamination control network.  

Presentations:

  • Environmental Air Monitoring of PFAS Contamination by Thermal Desorption Gas Chromatography Mass Spectrometry — Allen Chan, Balazs NanoAnalysis
  • Airflow Visualization: Using Smoke to Make Things Clearer — Norm Goldschmidt, Genesis
  • Common Pitfalls from Construction to Operation for New Generation AMC Cleanrooms — Steve Wolfe, Microtest
  • Surface Molecular Contamination (SMC) Particles: 20 Nanometer/.02 Micron Particle Collection on Surfaces — Victor Chia, Balazs NanoAnalysis and and David Browne, Pentagon Technologies 


Comprehensive Strategies for Sterile Compounding of Hazardous Drugs: Garbing, Decontamination and Residue Management
3:25 - 5:15 p.m.
Chair: Michael Myers, Contec

Presentations:

  • Taking Action Against Hazardous Drug Residues: Reduce, Recognize, and Remediate - Dr. Mark Wiencek, Contec
  • USP Chapter 800: Special Considerations for Garbing and HD Decontamination - Michael Myers, Contec


Tuesday, May 7, 2024

Special Topics in Contamination Control
9:30 - 11:20 a.m.

Chair: Jim Polarine, STERIS

Presentations:

  • Use of Cavitation and Acoustic Streaming in Surface Cleaning — Dr. R. Nagarajan
  • Aseptic Processing – A Standards Update — Gordon Ely, LexaMed, LLC
  • Mitigating A.I. Data Center Failures from "Free-Air" Cooling Contamination — Jason Roth, SET3


The Future of Contamination Control
1 - 2:50 p.m.
Chair: Jim Polarine, STERIS

Cleanrooms, clean zones, and controlled environments practice contamination control principles that have been established over the last 60+ years. As we move forward,  what are the challenges we will be facing? What are the current and new trends and the paths to achieve these goals? How can we achieve our quality goals on a consistent basis? These presentations will examine the major clean industries and will focus on the future paths and requirements for consistent product quality and achieving the customer’s goals. 

Presentations:

  • A Roadmap to the Future of Contamination Control - Anne Marie Dixon-Heathman, Cleanroom Management Associates
  • The Use of AI in Environmental Monitoring - Mark Hallworth, Particle Measuring Systems
  • The Application of Robotics - Anne Marie Dixon-Heathman, Cleanroom Management Associates
     


Cleanroom Particle Classification, Monitoring and Sampling Techniques
3:10 - 5 p.m.
Chair: Hasim Solmaz, Lighthouse Worldwide Solutions

Particle count in a cleanroom is the only method to classify your cleanroom as per the ISO14644 standards. For proper operations and continuous compliance, environmental monitoring is essential. Both classification and monitoring require proper particle sampling design to avoid potential errors and losses. This session will cover cleanroom classification, cleanroom particle monitoring, and particle sampling techniques as required in the new ISO/TR 14644-21:2023.

Presentations:

  • Digitalization of the Environmental Monitoring Program: Leveraging CCS, Pharma 4.0, and the Smart Particle Counters — Jason Kelly, Lighthouse Worldwide Solutions
  • Detecting Aerosol Events Caused by Nanoparticles — Mike Turnure, TSI
  • The Rationale of Two-Point Calibration for Aerosol Photometers — Meng Hu, ATI


Wednesday, May 8, 2024

Demystifying GMP Annex 1: Best Practices and Regulatory Updates
8 - 9:50 a.m.
Chair: Dave Nobile, Contec

This session is a deep dive into the critical guidelines outlined in the EU GMP (Good Manufacturing Practice) Annex 1, focusing on sterile medicinal products. Our experts will provide valuable insights into the latest revisions and regulatory updates, sharing best practices for compliance. Whether you're a pharmaceutical professional, regulator, or quality control expert, this session offers a comprehensive understanding of the essential requirements, contamination control strategies, and quality standards necessary to maintain sterility and safety in pharmaceutical manufacturing. Join us to stay at the forefront of GMP compliance and ensure the highest quality of sterile products.

Presentations:

  • Annex 1: Contamination Control Strategy for Material Transfer in the Aseptic Area: Best Practice for Packaging and Surface Disinfection — Renee Buthe, STERIS
  • Interpreting Cleaning and Disinfection Requirements for Annex 1 — Neil Simpson, Contec


Taming the Mold: Fungal Spore Contamination Control in Cleanrooms
10:10 a.m. - 12 p.m.

Chair: Ziva Abraham, Microrite

This session sheds light on the often difficult but critical aspect of contamination control: fungal spores in cleanrooms. Fungal contamination can compromise product quality and safety, making it essential for professionals across industries to understand the unique challenges posed by these tiny invaders. Our expert presenters will discuss effective strategies, monitoring techniques, and preventive measures for controlling fungal spore contamination in cleanroom environments. By attending, you will gain insights into safeguarding your cleanroom operations and learn best practices to ensure that your controlled environment remains a bastion of sterility and precision.

Presentations:
  • Fungal Spore Case Studies in Cleanrooms — Jim Polarine, STERIS
  • Challenges in Identifying Mold — Ziva Abraham, Microrite
 
Design and Energy Conservation for Advanced Facilities and Cleanrooms
3 - 4:50 p.m.
Chair: Ahmad Soueid, HDR Architecture, Inc.
 
This enlightening session delves into the art and science of cleanroom design, offering a comprehensive overview, from cutting-edge technologies to the latest regulatory requirements, attendees will gain understanding of the considerations that influence cleanroom architecture. Experienced experts will share their insights and real-world examples, allowing you to explore the critical factors impacting cleanroom design, including airflow, filtration, materials, and contamination control. Whether you are a seasoned professional or a newcomer to the field, this session provides the knowledge and inspiration to combine good cleanroom design with responsible and practical sustainability.

Presentations:
  • Reducing Fan Energy Consumption in Controlling Airborne Contamination, Transmission and Migration: Inspirations from New 14644 Cleanroom Standards — Wei Sun, Engsysco
  • Choosing the Right Clean Class and Saving Money — Matthew Fickett, HDR Architecture
  • Consideration for Prefabricated Cleanroom Solutions — Dennis Powers, G-Con


Thursday, May 9, 2024


Navigating Emerging Markets in Contamination Control
8 - 9:50 a.m.
Chair: Dijana Hadziselimovic, STERIS

This engaging session explores the dynamic landscape of contamination control within emerging markets. As industries continue to grow and globalize, so do the challenges associated with maintaining stringent cleanliness and safety standards. Participants will gain valuable insights into the unique factors that affect contamination control in emerging markets, such as regulatory variations and changes, supply chain complexities, and evolving technologies. Whether you're an industry professional or a researcher, this session will equip you with the knowledge and tools needed to take advantage of emerging markets while safeguarding product quality and safety.

Presentations:

  • Material Decontamination Considerations for Advanced Therapy Medicinal Products (ATMP) — Brian Bosso, STERIS
  • Innovative Digital Particulate Contamination Detection for Real-Time Characterization of Surface Cleanliness per IEST-STD-CC1246 — Emily Lynch and Clement Marmorat, Blue Origin
  • cGMP Meets THC: Implementing Established Best Practices for Optimized Cannabis Contamination Control — Jason Hadley, FILTR/Lighthouse Worldwide Solutions


Panel Discussion: Portable Cleanrooms, Modular Cleanrooms, and Design-Build Cleanrooms
10:10 a.m. - 12 p.m.

Hear from a panel of industry experts as they discuss the pitfalls and considerations of portable cleanrooms, modular cleanrooms, and design-build cleanrooms.

Panelists:

  • Dennis Powers, G-con
  • Ward Patton, Simplex

Presentations:

  • Lessons Learned from the Construction of a Portable Cleanroom for NASA OSIRIS-REX Mission Deintegration — Jeff McQuillan, Jacobs Technology

 

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