Contamination Control/NANO Conference Sessions

 

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

Sessions are subject to change and will be updated as presentations are finalized and added to the program line-up.

Tuesday, May 1, 2018

8:00 - 10:00 a.m.
Air Flow Visualization Techniques and Technology: How to Avoid Common Mistakes and Misunderstandings Related to Smoke Studies Deep Dive Session
Chair: Morgan Polen, Microrite
This presentation will discuss the various methods and techniques of air flow visualization as well as provide examples of improperly tested facilities including FDA 483 Observations and warning letters related to airflow visualization.

10:15 a.m. - 12:15 p.m.
Environmental Monitoring in Cleanrooms and other Controlled Environments

  • Environmental Monitoring Data - Improving Insight and Avoiding Missteps -- Joseph McCall, STERIS Corporation
  • Environmental Monitoring: Using Laser Induced Fluorescence to Monitor Airborne Viable
    Contamination in Real-time -- Mike Dingle, TSI, Inc.
  • Common Pitfalls in Developing an EM Program Without Understanding Product Requirements -- Ziva Abraham, Microrite


1:15 - 3:15 p.m.
Contamination Control in Cleanrooms and Other Controlled Environments
Chair: Anne Marie Dixon, Cleanroom Management Associates, Inc.

  • Contamination Control Case Studies -- Jim Polarine, STERIS Corporation
  • Cleaning Verification through use of UV-Visible Material Application -- Kyle Mulder, Technical Safety Services, Inc.
  • Avoiding Cross Contamination with Vectors and Extraneous Contamination of Cell Therapy Products; Risk Assessment from Facility to Design to Product Release -- Ziva Abraham, Microrite

3:30 - 5:30 p.m.
Risk Assessments in the Cleanroom Industry
Chair: Jim Polarine, STERIS Corporation
Risk assessments are a routine and necessary part of cleanroom operations. Risk assessments are part of CAPA investigations, disinfectant validation programs, and environmental monitoring programs. They are a very valuable tool to reduce and control costs and determine possible root causes in CAPA investigations. Overall risk assessments allow cleanroom operations to operate in a better state of overall control.

  • Risk Assessments: Contamination Control Case Studies -- Jim Polarine, STERIS
  • Risk Assessment as Part of the Draft Annex 1 Documented Contamination Control Strategy -- Ziva Abraham, Microrite
  • Once Upon a Time… The Fantasy of Risk! -- Anne Marie Dixon, Cleanroom Management Associates, Inc.


Wednesday, May 2, 2018

8:00 - 10:00 a.m.
Selecting Cleanroom Consumables: Operator Comfort vs. Cleanliness?
Chair: Greg Heiland, Valutek

Who is the ultimate “customer” in your critical environment: the technician, or the downstream owner of the product that you are manufacturing? The presentation will share “how to” assess your current glove and wiper usage, and determine, per IEST guidance, the most appropriate glove and wiper substrate material, and post-processing. Also included will be information on specifying ESD and cleanroom seating..
  • Demystifying the Process of Specifying Technical Seating for Clean Room and ESD
    Environments -- Daryl Hensley, Biofit Engineered Products
  • Form. Function, and Comfort in the Cleanroom -- Barb Kanegsberg, BFK Solutions LLC
  • Panel Discussion

10:15 a.m. - 11:45 a.m.
Contamination Control for Aerospace Challenging Applications
Chair: Roger Diener, Consultant
Co-Chair: Taguhi Arakelian, Jet Propulsion Laboratory
The critical needs for contamination control in the aerospace industry are as varied as is the broad spectrum of the missions that will be flown or launched. It is critical that contamination be controlled to the lowest possible levels during component and vehicle assembly and preparation to avoid equipment or mission failure. Failures may include anything that will negatively affect vehicle functionality or instrumentation performance, or anything that will allow viable or non-viable organisms to contaminate experimental chambers or be allowed to proliferate or spread beyond the confines of the vehicle in extra-terrestrial missions. Such contamination control challenges ranging from material selection to garment protocols to stringent organic and biological control requirements may determine the success or failure of each costly and unique mission. This session will highlight some certain contamination control challenges that require special solutions, more critical than that of traditional cleanroom applications.

 

  • The Evolution of Woven Cleanroom Wipers for Critical Aerospace Mission Applications -- Brad Lyon, Texwipe
  • The Evolution of Cleanroom Garments for Critical Aerospace Mission Application -- Steve Glosson, Precision Fabrics Group
  • Finding and Addressing Hidden Sources of Contamination in your Consumables -- Michael Gottfredson, UltraTape


3:15 - 5:15 p.m.
Nanotechnology in the 21st Century
Chair: Ahmad Soueid, HDR Architecture
  • Design Impacts for Cryo-EM Facilities in Nanotechnology Research -- Jack Paul, HDR Architecture
  • Effective Passive Shielding With High Performance ACS Mitigation -- Lou Vitale, VitaTech Engineering
  • Implementation of Modern Controls and Commissioning for Nanotechnology Cleanrooms -- Jon Craig Rossrucker, Abbie Gregg
  • Incorporating Statistical Methods into Analyses of Walker-Induced Floor Vibrations -- Byron Davis, Vibrasure


Thursday, May 3, 2018

8:00 - 10:00 a.m.
Novel Technologies and Techniques for Measuring Particles in Challenging Environments
Chair: Morgan Polen, Microrite

  • Novel Technologies for Particle Size Analysis and Particle Identification -- Yitzhak Vanek, Persys Engineering
  • Macro Particles in Cleanrooms -- Morgan Polen, Microrite

10:15 a.m. - 12:15 p.m.
Current Trends in Air Filtration Technology
Chair: Les Goldsmith, Envirco

  • A Study on the Mechanism of Aerosol Penetration Through the Pinhole of HEPA Filters -- M. A. Mohd Nor, Shibaura Institute of Technology
  • Performance Evaluation of the Air Curtain to Intercept the Heat Convection -- Ryo Nagatsuka, AIRTECH JAPAN, LTD.
  • Smart EC Motorized Impellers Provide Higher Level Information for Cleanroom Monitoring and Management -- Howard Abramowitz, AirCare Automation Inc. 
  • The Use of PTFE Filtration and its Proper Application -- Matthew Crouch, Camfil USA, Inc. (North America)

1:15 - 3:15 p.m.
USP 797/800 Projects: A Team Approach
Chair: Jason Dollarhide -- Hodess Cleanroom Construction

  • How does a Team Approach Help Achieve USP 797 & 800 Compliance? -- Jason Dollarhide, Hodess Cleanroom Construction
  • Advantages of Modular vs. Stick Built Construction -- Bill Roy, Plascore Modular Systems
  • Cleaning and Protocol Best Practices and Challenges -- Erika Hodess, Protocol Management Systems
  • Requirements For A Successful Certification -- Brian Marquis, PharmaCerts

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