This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviours.

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. The role of Media fills will also be explained; along with details on how to successfully perform a media fill. 

Why Should You Attend:

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
• Principles of microbiology and microorganism recovery in relation to cleanroom environmental monitoring
• Understand the gowning requirements associated with different cleanroom classifications
• Explain the basic principles of aseptic processing, including:

               o Cleanliness classifications
               o Process differences between aseptically produced and terminally sterilized product
               o Relation of manufacturing and handling procedures to sources of product contamination
               o The differences between cleaning, disinfection and sanitization
               o Proper cleaning/disinfectant technique
               o Elements of a robust environmental program and why EM is important
               o The purpose of media fills, and elements critical to their success
               o 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

Course Outline:

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

Topic 4:  Aseptic Validation

             · The purpose of media fills, and elements critical to their success

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Lab managers,
• Regulatory personnel,
• Quality control analysts and
• QA professionals,
• Engineering /Technical Operations
• Manufacturing operators,
• Sterility assurance professionals
• Validation
• All personnel who work for pharmaceutical manufacturing and contract manufacturing organizations where aseptic processing and technique are required