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. 

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

Monday, October 5, 2020

9:30 - 11:10 a.m. Central Time
Contamination Control in Cleanrooms
Chair: Jim Polarine, STERIS

This session will cover how contamination in cleanrooms can affect control and product sterility in cleanroom operations.  Common sources of cleanroom contamination can come from raw materials, poor gowning practices, operator behavior, aging facilities, and items brought into the cleanroom.  This session will cover case studies in contamination control in pharmaceutical, biotech, and medical device cleanrooms.  Risk assessments and CAPA investigations will be covered that relate directly to improving contamination control programs. Procedures will be covered to proactively prevent future product sterility failures and large-scale contamination events. This seminar will benefit non-sterile and sterile manufacturers.

  • Contamination Control Strategies: Facts and Sciences to Consider — Jim Polarine, STERIS
  • Particulate Matter in Medicinal Products — Ziva Abraham, Microrite
  • Contamination Risk Factors for Sterile Cleanroom Apparel — Dalia Taylor and Daniel Peter Hammel, DuPont
  • Disinfectant Residues and their Implication to End Users — Grant Lindh, Ecolab

11:20 a.m. - 1:00 p.m. Central Time
Design and Construction of Critical Environments
Chair: Ahmad Soueid, HDR Architecture, Inc.

  • Addressing Noise Concerns in Cleanroom Environments — Alex Odom, ACENTECH
  • Common Wisdom in Vibration and Acoustic Mitigation: True or False? — Byron Davis, Vibrasure and Ken Filar, HDR Architecture, Inc.
  • Monitoring for Nanoparticles — Kelvyn Henderson, TSI
  • Merging Clean and Secure Spaces — Brad Hodges and Stephen Garvey, SMRT Architects and Engineers

1:45 - 3:25 p.m. Central Time
Particle Measuring
Chair: Morgan Polen, Microrite

  • Using Laser Induced Fluorescence to Monitor Airborne Viable Contamination — Michael Dingle, TSI
  • Particle Counter Calibration Standards and Specifications — Bill Shade, Microrite
  • Development and Qualification of a Novel Particulate Fall-out Monitor to Monitor Contamination During Rocket Launches — Karen Holland, XCAM, Ltd.
  • Active Air Sampling Technology & ISO 14698 — Jason Kelly, Lighthouse Worldwide Solutions

3:35 - 5:15 p.m. Central Time
Contamination Control in the Cannabis Market
Chair: Jim Polarine, STERIS

The idea of contamination control in the Cannabis market may seem unimportant since when cannabis is grown properly with organic fertilizers, no pesticides, and dried in a clean environment, it is generally safe for consumption. Cannabis is, after all, not cultivated in a microbial free environment. The issue is when companies expand into large-scale manufacturing operations, it’s imperative to control and test for potentially harmful organisms and pesticides to ensure a Quality product. Social pressures for safe, quality, efficacious, consistent cannabis is placing a growing demand for lab tests to ensure the safety not only of medicinal marijuana, but recreational cannabis as well. In this rapidly developing market, regulations specific for this segment have been lagging behind until recently when both in Canada and the US, strict guidelines have been imposed on the industry to ensure the final product does not contain significant levels of harmful substances. This session will cover how contamination in the cannabis market can affect control and product quality.  Common sources of contamination can come from raw materials, poor gowning practices, operator behavior, rapidly expanding facilities or not fit for size and purpose, and items brought into the facility.  This session will cover the history of the cannabis market, contamination control in the cannabis cultivation and extraction processes, and ways to improve control and production in the cannabis market.

  • Cannabis: Keeping it Clean — Beth Kroeger-Fahnestock, STERIS
  • Cannabis Plant Diseases — Ziva Abraham, Microrite
  • TRUE CFM Implementation and Results in Fan Filter Units — Howard Abramowitz, AirCare Automation Inc.


Tuesday, October 6, 2020

11:20 a.m. - 1:00 p.m. Central Time
Surface Cleaning and Cleanliness Measurement
Chair: Dr. Nagarajan

Process industries for the manufacture of precision products and assemblies are facing increased exposure to contamination-related failures as underlying technologies advance. Defining the acceptable cleanliness levels of components, facilities and work surfaces is becoming a critical need. Implementing methods to monitor contamination to required levels and installing cleaning processes to achieve these are  major challenges by these industries. "How Clean is Clean?" is a question that continues to engage Contamination Control professionals. This Session will contain presentations on techniques for surface cleaning, as well as for cleanliness measurement. 

Cleaning techniques can encompass methods that are dry & wet; aqueous & non-aqueous; gentle & aggressive; immersive & non-immersive; automated & manual; parts-focused & equipment/ facilities-focused; etc. Measurement methods can include: direct & extractive; particulate/ organic/ ionic/ viables; in-situ/offline; quantitative/ qualitative; accelerated/ functional; etc. The interplay between surface cleaning methods and cleanliness measurement methods will also be highlighted in this session, so that cost-effective decisions may be made on both aspects.

  • Spore Log Reduction Using Ultrasonic and Megasonic Frequencies — Dr. Nagarajan
  • Surface Cleanliness, Specification and Monitoring — Koos Agricola

1:45 - 3:25 p.m. Central Time
Anti-483 Forum: How to Avoid an FDA Early Warning Letter Panel Discussion
Chair: Greg Heiland, Valutek

Description coming soon.


Wednesday, October 7, 2020

1:45 - 3:25 p.m. Central Time
Mold Contamination Challenges Deep Dive
Presenter: Ziva Abraham, Microrite

All industries face mold contamination issues, be it medical products, hospitals, aerospace, paint, etc.  Without understanding the nature of mold, their myriad of reproduction methods, their fascinating way of communication and survival strategies, remediating mold contamination is a futile exercise.

This two hour session will address:

  • Reasons behind current challenges
  • Understanding mold classes and sporulation patterns and how easy to kill mold can switch its proliferation method where the spores are impossible to eradicate.
  • Understanding Disinfection and Disinfectant Qualification as it relates to Mold
  • How disinfectant label claims can be misleading at times
  • Understand why investigating and managing mold contamination can be difficult without proper knowledge of mold and controlled environments
  • Discussion on false positive mold results- causes and solutions
  • Use the knowledge of teleomorphs and anamorphs to understand clinical relevance of the mold isolates

3:35 - 5:15 p.m. Central Time
Why There is No Such Thing as an ISO Class 5 Wiper: Wiper Selection and the New RP004.4 Explained
Chair: Dave Nobile, Contec

This session will detail the changes made from RP004.3 to RP004.4 and discuss the rationale and anticipated benefits/effects of the method changes. Particular emphasis will be placed on discussion of the newly added guidance for wiper selection, its limitations, and how end users should use the guidance in selecting wipers appropriate for their applications.


Thursday, October 8, 2020

9:30 a.m. - 11:10 a.m. Central Time
Contamination Control in Medical Devices
Chair: Doug Harbrecht, Sterility Assurance LLC

  • Biocontamination Control for Medical Devices — Doug Harbrecht, Sterility Assurance, LLC
  • Endotoxin Contamination Control for Medical Devices — Jason Hoffbeck
  • Particulate Contamination Control for Medical Devices — Doug Harbrecht, Sterility Assurance, LLC
  • Portable Tabletop Clean Air Device: Creating ISO Class 1 Level Workspace Within 2 Minutes — Koji Miyasaka, Kanomax

11:20 a.m. - 1:00 p.m. Central Time
Contamination Control in Compounding Pharmacies and Aseptic Isolators
Chair: Greg Heiland, Valutek

In the ever-changing regulatory world for compounding pharmacies, it can be difficult to understand how to achieve compliance. There are so many aspects that it may seem daunting to make sure your facility and practices are continually improving and beating expectations. This session will enlighten you on best practices and engineering controls that will produce quality product.

  • Aseptic Training Plans: Challenges and Solutions for Compounding Pharmacies and 503B Facilities — Joseph McCall, ADMA Biologics
  • VHP Application Overview and Best Practices — John Klostermyer, STERIS
  • Cleaning in Sterile Compounding Environments - USP Chapter <797> and Practical Considerations — Michael Myers and Mark Wiencek, Contec


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