A sterile product is one that is free from all living organisms, whether in a vegetative or spore state. This is an absolute condition, something cannot be partially or nearly sterile, the presence of a single viable organism represents a failure of the product, and the systems (environment, equipment, and procedures as well as operators) used to produce it. Asepsis, that state in which all aseptically filled sterile products are manufactured, cannot be established as “sterile.” Aseptic processing is the most demanding of manufacturing processes. It requires precise attention to operator training and behavior, process validation, production process documentation, plant and equipment maintenance and change control management.

This two-day course presents the technical essentials that govern aseptic processing and provides practical approaches for attendees to troubleshoot and manage their aseptic operations. this program curriculum is designed to address aseptic filling common to pharmaceutical and biotech products with emphasizes industrial microbiology, various types of sterilization, and facility design fundamentals in the context of regulatory compliance, Good Manufacturing Practice, and FDA/international current thinking.

This conference provides valuable take home knowledge and networking opportunities for the aseptic processing and sterile environment professional.

This two-day comprehensive course with interactive case studies & workshop covers a wide range of topics including:

Regulatory requirements and reality
Sterility testing and current industry issues
Key strategies to manage aseptic operations
Sterility sampling program
Compendial requirements for media and incubation
Interpreting sterility test results
Sterilization Principles
Common methods of sterilization; Terminal sterilization, Steam sterilization, Autoclaves, Dry heat and radiation, Chemical/EtO, and Lyophilization
Establishing sterilization process cycles
Alternative methods of aseptic processing
Sterilizer qualification and validation
Investigating sterility failures
Trending of sterility tests results
Common causes for sterility failures
Designing and starting-up a GMP clinical filling Facility for potent material processing
Case studies:

Aseptic Container- Closure systems
Conducting a media fill failure investigation
Interactive workshop:

Aseptic processing equipment:
Project management for Design, Procurement, Acceptance Testing and Qualification