The Microbial Factor of Non-Sterile Cleaning Validation

This webinar will focus on the microbiological element of non-sterile manufacturing cleaning validation and the need to design a robust cleaning routine. It will address the different pharmacopoeia regulations and current regulatory trends. It will also cover the theory in setting the baseline profile and limits along with determination of routine testing.

Why Should You Attend:

All non-sterile pharmaceutical products require some level of microbial control and bioburden testing. A satisfactory cleaning validation must ensure the best chances of consistent satisfactory environmental control.

• What exactly is needed to set the guideline for a non-sterile manufacturing environmental monitoring program?
• What are the actions your company must consider in controlling a non-sterile environment?
• Is your cleaning validation sufficient to support the sanitation schedule of the manufacturing environment?
• Are there any actions that can be taken to prove there is no negative product impact due to environmental conditions?

If you are looking for the answers to the above questions you will certainly benefit from attending this webinar.

This presentation will review:

• What is significant as microbial contamination and what is historically acceptable bioburden
• The microbiological principles of cleaning validation in a non-sterile environment
• The test methods available, including disinfectant qualification
• Environmental monitoring, investigations and trending environmental data

Learning Objectives:

Upon completing this webinar, participants will be able to:

• Determine how to set a baseline microbial profile
• Determine the historical trends and the action/alert limits for non-sterile production
• Understand which test methods are more effective for use for each situation
• Determine what a significant event is and what the product impact would be for the recovery of isolates of concern.

Areas Covered in the Webinar:

• Defining what exactly is considered contamination of non-sterile pharmaceuticals
• Routes of ingress of contamination
• Focuses of protection from contamination
• Review of cleaning and disinfection
• Microbiological expectations for cleaning validation
• Requirements of the regulatory agencies
• Establishing effective environmental monitoring systems
• Testing procedures
• Investigations

Who Will Benefit:

This webinar will provide valuable information to all companies that are in need of creating a cleaning validation program for non-sterile manufacture of pharmaceuticals or the improvement, remediation of existing programs.

• QA/QC personnel
• Validation specialists
• Manufacturing personnel involved in validations
• Environmental monitoring specialists

Instructor Profile:

Steve Yeger, is owner and President of Steven Yeger Consulting, a consulting firm based in the United States with that has serviced pharmaceutical clients worldwide. Prior to starting his Consulting career, Steve worked for Wallace Laboratories, Inc. as the group leader of medical diagnostics-infectious diseases, Bristol-Myers Squibb bacteriology, managed the Microbiology department at PACO pharmaceutical (a CMO) and managed quality operations for antibiotic manufacturers and clinical supplies. Steve holds a Bachelor of Science degree in Microbiology from the Ohio State University and has over thirty years of experience in the medical diagnostics, medical devices and pharmaceutical industries.