2022 PMF Fall Forum: MICROBIAL RISK ASSESSMENT - Identifying and Controlling Risk

PMF is very excited to announce the first in-person PMF Fall Forum since 2019. This year’s PMF Fall Forum: MICROBIAL RISK ASSESSMENT - Identifying and Controlling Risk is a timely topic that will be of broad interest to the Pharmaceutical and related industries. Leading industry experts will present and discuss topics related to various aspects of microbial risk assessment.

Microbial Risk Assessment (MRA) has taken center stage for the evaluation of facility design, manufacturing processes, investigations, product and environmental monitoring, microbial testing strategies and frequencies, field-alerts and product recall decisions, and more.  What has been commonplace in the food industry for decades has come of age in the Pharmaceutical, Biotechnology, and Biologics industries. Industry professionals are being asked to perform MRA throughout the product lifecycle. Product development, regulatory submissions, facility and process design, environmental monitoring procedures, microbial testing strategies, and patient safety assessments, are all impacted.

This year’s PMF will take a holistic look at the concepts of Microbial Risk Assessment with meaningful topics from front-line professionals who have implemented MRA and will approach the topic from various view-points as defined below. The presentations will additionally focus on identifying and controlling microbial risks. We are privileged to have well-recognized Subject Matter Experts share their knowledge and “war stories” with tackling the challenges associated with microbial risks and control strategies.

“Microbial Risk Assessment – Identifying and Controlling Risks” will provide an excellent opportunity for participants to acquire the knowledge and learn the skills necessary for managing these challenges.

MAIN TOPICS

• Objectionable Organism Risk Assessment 
• Fundamentals of Disinfectant Efficacy Testing
• Risk Assessment in Developing an EM Program
• Case Study of a Purified Water System - Reducing Risk by Identifying Intermittent Microbial Disturbance
• Contamination Control – Blurring the Dichotomy of Sterile and Non-sterile Manufacturing. How Risk Assessment Guides us to the Critical Point(s) for Product/ Patient Safety
• USP 60-62, the Methods, What We're Looking for and Why They're in Place
• Risk Assessments and War Stories for Microbial Control

WHO SHOULD ATTEND?

As microbial risk assessment is a multi-departmental exercise, this forum will have broad appeal and applicability.

• Microbiology laboratory supervisors, microbiologists, environmental monitoring technicians  responsible for testing and release of Pharmaceutical, Biologic, and Biotechnology products and microbiology laboratory and QC Microbiology GMP operations
• Regulatory and Quality compliance personnel responsible for auditing and ensuring GMP compliance and product quality, and those involved in patient safety assessments, field alert reports, and product recall decisions
• Manufacturing, Engineering, and Validation personnel responsible for facility design, water systems, process validation, trouble shooting and investigations
• Training department professionals responsible for the training and qualification of department staff who are tasked with performing risk assessments
• Chief Medical Officers who perform health hazard assessments
• Any other individual who may assist in microbial risk assessments

 

Speakers

Robert Guardino, Moderator 

Founder & Principal Microbiologist, MicroGuard Consulting LLC. President / CEO of MicroGuard Devices, LLC

Mr. Guardino is the founder and principal microbiology consultant of MicroGuard Consulting, LLC, and President / CEO of MicroGuard Devices, LLC. Mr. Guardino has served as an international consultant on four continents over the past nine years. Mr. Guardino earned a Master of Science Degree in Clinical Microbiology. His career in Microbiology over the past four decades spanned several industries including Clinical Microbiology, Rapid Microbial Diagnostics / Medical Devices, and Pharmaceutical Microbiology. His Quality System / GMP Regulations experience spans over 30 years. Areas of expertise include microbial contamination and control in pharmaceutical manufacturing, aseptic processing and sterility assurance, microbiological method suitability and testing requirements, disinfectant qualification, pharmaceutical water systems and environmental validation, and compounding pharmacy regulations and microbiology-related requirements. He has presented seminars and workshops domestically and internationally on pharmaceutical microbiology and related topics.

Donald Singer

Senior Microbiology Technical Consultant, North America, Ecolab 

Donald C. Singer is Senior Microbiology Technical Consultant, North America, for Ecolab, and a Fellow in the American Society for Quality.  He was formerly a GSK Senior Fellow.  Don has been Chair of the USP General Chapters - Microbiology Committee of Experts and a member since 2000.  He is a Certified GMP Professional, Certified Six Sigma Green Belt, Certified Specialist Microbiologist and is a member of the European Pharmacopeia Group 1 Microbiology Committee. Don is also an adjunct professor in the Biopharmaceutical Quality graduate program at the University of Maryland Baltimore County.  He has been an author of the PDA Technical Reports for Contamination Control Strategy, Challenges in Pharmaceutical Package Integrity and Exclusion of Objectionable Microorganisms.  Don’s career spans over 40 years of research and quality control. 

Presentation Title: Contamination Control – Blurring the Dichotomy of Sterile and Non-sterile Manufacturing. How risk assessment guides us to the critical point(s) for product / patient safety

Abstract:

• Holistic approach to contamination control supports the pharmaceutical microbiologist
• Value of both USP <1115> and <1211> for an integrated approach
• Microbiological control in cell therapy manufacture teaches us about balance for patient safety 

Randy Hutt 

Principal Consultant, MicroDoc LLC

Dr. Randy Hutt has 40 years of experience in the Pharmaceutical and Biological industries, management in pharmaceutical companies such as American Regent, Inc. (formerly called Luitpold Pharmaceuticals, Inc.), Wyeth-Lederle, Burroughs Wellcome, and Schering Plough.  Currently, Dr. Hutt has functioned as a Consultant since February 2021. Previously, Dr. Hutt was Associate Director of Sterility Assurance and Microbiology, which included the laboratory and environmental monitoring at Luitpold, and has over 20 years of QA/QC experience including that at other companies.  In addition, she has 10 years of aseptic production management experience and several years of consulting, both in the US and internationally, performing pharmaceutical microbiological Investigations, cGMP audits, and training on how to perform audits. She has given presentations on Microbial Investigations to the Parenteral Drug Association (PDA), the Pharmaceutical Microbiology Forum (PMF) and the Institute of Validation Technology (IVT).  Her Ph.D. is in Microbiology, specializing in viruses, particularly Herpes viruses, from the Hershey Medical Center (part of Penn. State University). 

Presentation Title: Risk Assessments and War Stories for Microbial Control

Timothy Cser

Technology Specialist, MilliporeSigma

Tim Cser is a Senior Technology Specialist with MilliporeSigma.  Tim graduated in 1997 from Cal Poly, San Luis Obispo with a degree in Microbiology with an emphasis on Industrial Microbiology.  Tim started his career with Clorox working on antimicrobial effectiveness studies.  He continued his career at Biolog where he gained 7 years of experience with microbial identifications.  For the last 16 years he’s worked at MilliporeSigma in a variety of roles involving Pharmaceutical/Biotech QC Microbiology. 

Presentation Title: USP 60-62, the Methods, What We're Looking for and Why They're in Place

Anthony Grilli

Focus Laboratories

Tony holds a graduate degree in microbiology from Rutgers University.  For over 25 years, Tony has managed several contract laboratory organizations to regulatory and financial success.  Mr. Grilli has advised clients on matters of regulatory compliance, technical method validation, and microbial remediation.   He has hosted and conducted audits, authored protocols, designed laboratories, developed laboratory quality systems, remediated 483 observations, and developed Lean Sigma laboratory processes.  He has published in peer reviewed journals and has presented at seminars.  He is active in several organizations, including President Elect of the Metro Chapter of Parenteral Drug Association (PDA), Controlled Environment Testing Association (CETA) and American Standard Test Methods (ASTM).

Presentation Title:

Anthony Bevilacqua

Principal Scientist at Mettler-Toledo Thornton 

Dr. Anthony Bevilacqua is a Principal Scientist at Mettler-Toledo Thornton.  He earned a doctorate in Analytical and Physical Chemistry from Tufts University.  He has been at Thornton since 1994, leading the instrumentation development for Thornton in several areas of R&D including improved high temperature conductivity measurements, the impact of CO2 on pure water, use of ultrapure water (UPW) as a conductivity solution standard, development of digital sensors, and the expansion of real-time analytical parameters (conductivity, TOC, microbial detection, ozone, sodium, and silica) for measurement and control of high purity water systems, including pharmaceutical water systems. He has been a chair and member of multiple USP Expert Committees, currently with the Chemical Analysis Committee and specializing in standards related to sterile and non-sterile pharmaceutical waters.

Presentation Title: Case Study of a Purified Water System - Reducing Risk by Identifying Intermittent Microbial Disturbances

Abstract:Today, it is common to release water (Purified Water and Water for Injection) continuously for its chemical attributes (TOC and conductivity). However, this same water would be released at risk for its microbial attributes due to the time required to grow and enumerate microbial colonies. As an example, during the monitoring of the microbial attributes of a water system by traditional growth-based methods, we observed inconsistent results from week-to-week. Instead of increasing the frequency of the traditional sampling to more samples per week, we employed an at-line, real-time, fluorescence-based microbial detection technology. These periodic test failures, which later turned out to be purification process failures, were occurring every 24-30 hours and traditional growth-based microbial detection methods could not detect these process failures. By examining continuous data, we correlated the auto-fluorescent count to a tank-filling process, then correlated the tank-filling process to an exhaustion of mixed-bed ion-exchange resin. By measuring continuously (every second), we observed periodic and serious purification failures, we corrected those failures, we generated consistent and compliant water quality, and we have a predictive tool to identify maintenance needs of limiting processes, i.e., processes that get consumed over time such as carbon bed and ion-exchange resin.