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 2, 2022


Roundtable Discussion: Comparing GMP Annex 1 with Other Essential Standards
9:30 a.m. - 11:00 a.m. Central Time
Chair: Dave Nobile, Contec

This roundtable discussion will compare the GMP Annex 1 with FDA guidance, USP guidance, and ISO 13408-1.


Airflow/Air Quality
11:20 a.m. - 12:50 p.m. Central Time
Chair: Morgan Polen, Microrite

Presentations

  • Sampling Procedures, Sample Tubing, Distance, tube diameter, and Bending effect on Cleanroom Monitoring and Classification with Particle Counters - Hasim Solmaz, Lighthouse Worldwide Solutions
  • AVS in Sterile Compounding Pharmacies - Kyle Mulder, TSS
  • Smoke Studies for Pharma Looking at the Guidance - Scott Drummand, Johnson & Johnson


Contamination Control in Cleanrooms
1:45 - 3:15 p.m. Central Time
Chair: Jay Postlewaite, Texwipe

Presentations

  • Striving for Complete Data Automation in a Cleanroom: Cleanroom Hardware that Allows Big Data and IoT Applications to Flourish - Bryon Hayes and Michael Lohmeyer, Grantek
  • The Importance of Cleanliness of Cleanroom Surfaces in Environmental Monitoring and Contamination Control - Koos Agricola, Brookhuis Applied Data Intelligence
  • Annex 1 Update: The Start of a Revolution in Environmental Monitoring - Michael Dingle, TSI
  • Case Study Panel - Morgan Polen, Microrite and Jim Polarine, STERIS


Tuesday, May 3, 2022

Particle Analysis and Control
10:15 - 11:45 a.m. Central Time
Chair: TBD

Presentations

  • Contamination Control Strategy: Digitalizing Particle Cleanroom Monitoring - Jason Kelly, LIghthouse Worldwide Solutions
  • Novel Technologies for Particle Size Analysis and Particle Identification - Yitzhak Vanek, Persys Engineering


Hard to Kill Stuff: Radiation and Disinfectant Resistance in Microorganisms
1:30 - 3:00 p.m. Central Time
Chair: Ziva Abraham, Microrite

This presentation aims to review the strategies by which microorganisms thrive in extreme radiation environments, extreme temperatures, in contaminated environments, at varying pH and salt levels. Beyond radiation resistance, the mechanisms microorganisms utilize to circumvent biocidal activities will also be discussed. Due to the limited research of such radio tolerant and disinfection resistant microorganisms, the major challenges that lie ahead will  also be  examined.


Wednesday, May 4, 2022


Pass Thru Decontamination in Cleanroom Operations
11:00 a.m. - 12:30 p.m. Central Time
Chair: Jim Polarine, STERIS

The process of bringing items such as bags, equipment, tools, carts, and intervention equipment into the cleanroom is the second most common source of contamination in cleanroom operations.   Pass Thru decon is an important and critical part of an effective contamination control strategy as outlines in the new draft Anne I.  This session will focus on strategies and methods to bring items into the cleanroom by applying effective decontamination methods to control and limit bioburden from entering the cleanroom and the aseptic processing area. Disinfection, decontamination, and cleaning are all measures that can control spores, fungi, and bacteria from entering the cleanroom operation. A key to a successful contamination control program is having an effective pass thru decontamination procedure into the cleanrooms, RABS, and BSCs.

Presentations

  • Sterile Hold Time Testing for Autoclaved Items Used within Parenteral Drug Manufacturing - Renee Buthe, STERIS
  • A Roadmap to Developing an Effective Bioburden Control Process in Pass Thru Applications - Jim Polarine, STERIS
  • Disinfecting Problematic Microbes - Dan Klein, STERIS


Contamination Control in Microelectronics
2 - 3:30 p.m. Central Time
Chair: Victor Chia, Balazs

Presentations

  • Mitigating Chemical Migration in a Semiconductor FAB: A Case Study - George Lei, Fluid Dynamics Solutions, Inc.
  • UHP Gas Component Testing for Microcontamination - Dan Cowles, Balazs NanoAnalysis
  • Metrologies for Process Tool Component Cleanliness - Victor Chia, Balazs NanoAnalysis

 

Thursday, May 5, 2022
 

Contamination Control in the Cannabis Industry
9:45 - 11:15 a.m. Central Time
Chair: Beth Kroeger-Fahnestock, STERIS

Presentations
Cleaning Validation and Contamination Control for Cannabis Cultivators and Manufacturers, Best Practices for Ensuring Patient & Consumer Safety - Beth Kroeger-Fahnestock, STERIS


Gene and Cell Therapy
11:30 a.m. - 1:00 p.m. Central Time
Chair: Joseph McCall, ADMA Biologics

Presentations

  • Cleaning Validation and Critical Cleaning of Cell and Gene Therapy Processes - Paul Lopolito, STERIS
  • Comparison of Biological Safety Cabinet Japanese Standard JIS K 3800 and American Standard NSF/ANSI 49 - Takumi Masubuchi, AIRTECH JAPAN, LTD.
  • The Importance of High-quality Foundational Aseptic Training for Emerging Biotechnologies - Benjamin Wilkin, Xilis


Sterile Compounding
1:30 - 3:00 p.m. Central Time
Chair: Michael Myer, Contec

Presentations

  • How to Maintain a Non-hazardous Sterile Compounding Pharmacy: The ABC’s of Cleaning and Disinfecting - Michael Myers, Contec
  • Protecting People in Pharmaceutical Applications: USP <800> and Hazardous Drug Handling - Dalia Taylor and Daniel Hammel, DuPont

 

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

 

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