2020 - Aseptic Processing Overview and Validation

Cleanroom classifications and the techniques for proper cleaning and disinfection are presented; along with a high-level overview of microbiology in regards to cleanroom environmental monitoring and the associated impact to product and patient health and safety. This course will also review the guidance provided in USP <1116> to ensure compliance with regulatory expectations are met.
Learning Objectives:
At the completion of this course, attendees will be able to:
Explain the difference between Aseptic and Bulk processing
Understand facility and personnel requirements necessary to maintain microbial control
Explain basic principles of microbiology and microorganism recovery in relation to cleanroom environmental monitoring (EM) and impact to product
Understand the gowning requirements associated with different cleanroom classifications
Explain basic principles of aseptic processing, including:
Cleanliness classifications
Process differences between aseptically produced and terminally sterilized product
Relation of manufacturing and handling procedures to sources of product contamination
The differences between cleaning, disinfection and sanitization
Proper cleaning / disinfectant technique
Elements of a robust environmental program and why EM is important
The purpose of media fills, and elements critical to their success
The role of isolator technology
Identify behaviors that are or are not appropriate when working in controlled areas, and why
Identify ways that they can impact/improve site-specific EM and aseptic behavior issues
Areas Covered in the Webinar:
Topic 1: Basic Micro Review
The role of environmental monitoring
Types & sources of microorganisms
The impact of microorganisms on product and patient health and safety
Topic 2: Review Aseptic Processing Basics
Cleanliness classifications
Process differences between aseptically produced and terminally sterilized product
Relation of manufacturing and handling procedures to sources of product contamination
The differences between and the purposes of cleaning, disinfection and sanitization
Proper cleaning techniques
The role of isolator technology
Topic 3: Review Clean Area Behaviors
Personnel gowning requirements
Good clean area behaviors/practices
Practices to avoid – and why
Review site-specific EM/aseptic behavior observations/risks & ask attendees to brainstorm ways to change/improve/eliminate these behaviors & risks
Topic 4: Aseptic Validation
The purpose of media fills, and elements critical to their success