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

Cleanroom classifications and the techniques for proper cleaning and disinfection are presented, along with a high-level overview of microbiology regarding cleanroom environmental monitoring and the associated impact on product and patient health and safety. 

This course will also review the guidance provided in USP <1116> to ensure compliance with regulatory expectations is met.

Why should you attend:-

After 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 about cleanroom environmental monitoring (EM) and its impact on product.
• Understand the gowning requirements associated with different cleanroom classifications.

Explain the basic principles of aseptic processing, including:-

• Cleanliness classifications
• Proper Engineering controls
• 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: -

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 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

Who will Attend:

Operations employees who are required to enter controlled environments as part of their job function – include some or all of the employees in the following departments:

• Production
• QC Micro
• Engineering & Validation
• Facilities / Maintenance
• Quality Assurance