• Review the Current Regulatory requirements for aseptic processing
• Learn the major areas of focus during regulatory inspections.
• Discuss most common deficiencies cited by the FDA

• Purpose of sterility testing and current industry issues
• Steps for establishing a sterility sampling program
• Common causes for sterility failures; equipment, procedures, and personnel
• Compendial requirements for media and incubation
• Interpreting sterility test results
• Product disposition issues: when is retesting justified?

• Review the basics of Sterilization Principles, such as D-values, Fₒ, sterility assurance levels (SAL) and regulatory requirements for sterilization.
• Discuss Common methods of sterilization; Terminal sterilization, Steam sterilization, Autoclaves, Dry heat, Chemical/EtO, and the advantages and differences between them.
• Review common deficiencies cited by inspectors regarding sterilization processes.

• High temperature
• Gas/vapor
• Radiation
• Mechanical
• Chemical

Sterility assurance monitoring tools and practices

• Chemical indicators
• Biological indicators

• Sterility Testing
• Compendial requirements
• Limitations of the method
• Interpretation of results
• Elements of investigation: Quality and Manufacturing sites
• Facilities/Equipment
• Personnel/Training
• Unusual events
• Assessing impact
• Corrective and preventive actions
• Consequences

• Review the requirements for Establishing sterilization process cycles
• Understand the basics of Sterilizer qualifications and review the information required in validation protocols (IQ/OQ and PQ)
• Review the typical information expected in sterilization procedures and the areas of focus during an audit.

• The importance of trending results of sterility tests
• Laboratory failure investigations
• Using Corrective and Preventative Action Plans (CAPAs)
• Conducting manufacturing OOS investigations
• Common deficiencies associated with OOS investigations
• Items to implement for avoiding and/or preparing for a failure

• Guidance documents
• Media fill study design
• Worst case conditions
• Interventions
• Discrepancy Systems
• Policies
• Roles and responsibilities
• Documentation
• Investigation
• Facility: cleaning and monitoring
• Equipment: sanitization and sterilization
• Personnel: training and qualification
• Interpretation of data
• Corrective and preventive actions

Interactive Exercise: The group will analyze data from a failed media fill, develop an investigation plan, and propose corrective actions.

This presentation will outline the considerations when selecting equipment and suppliers for aseptic processing process equipment for aseptic vial filling / lyophilization & inspection and aseptic syringe filling & inspection.

• The importance of correctly defining aseptic filling process capacity requirements accurately
  • Understanding product characteristics & how subtle product characteristics can fundamentally affect the selection of equipment
  • The effect of aseptic filling equipment selection on component preparation
  • The effect of aseptic filling equipment complexity and speed on reliability
  • How the approach to the design and implementation of aseptic process equipment can affect unit cost
• Selecting the equipment vendors
  • The competitive bid process
• Integrating equipment design considerations with equipment validation considerations
• Selecting the processing environment for an aseptic process
  • Traditional clean room
  • RABS
  • Barrier isolation technology
• Selecting filling technology
  • Positive displacement
  • Time pressure filling
  • Peristaltic filling
• Common design considerations for all aseptic processing equipment
• Specific design considerations for aseptic vial filling / lyophilization equipment
  • Vial washing
  • Vial depyrogenation
  • Vial filling
  • Lyophilizer loading systems
  • Lyophilizers
  • Vial capping
  • Equipment layout issues
• Specific design considerations for aseptic syringe filling equipment
  • Syringe component handling / transfer
  • Syringe filling
  • Equipment layout issues
• Selecting vial & syringe inspection equipment
• Documentation
  • What are important documents
  • Who is best suited to generating documents (the supplier or the customer)

This presentation will outline the key steps associated with the design, procurement, acceptance testing and qualification of aseptic processing equipment undertaken within a modified GAMP structure, and how this methodology is used to help minimize the technical challenges, cost and schedule overruns typically associated with implementing complex aseptic manufacturing processes. This presentation will address the following:

• The GMP Project Management Philosophy
  • What are the drivers for GMP project management
• What Is The Value Of GMP Project Management?
• The Objectives Of GMP Project Management
  • Management of equipment technical risk
  • Maintenance of the project budget & schedule
  • Ensuring total control of the equipment from equipment procurement to hand over to operations
  • Meeting regulatory expectations
• The GMP Project Management Approach
  • Summary of the key project steps from defining capacity requirements to hand over to operations
  • What are the key project documents and where do the URS / FS / HDS / SDS fit in
  • How to prepare the equipment procurement documentation
  • How to manage the Vendor, the technical issues, cost issues and the integration of the equipment into the facility
  • Factory acceptance testing preparation & execution
  • Transition to validation from engineering using site acceptance testing
  • Validation
• Typical Project Pitfalls
  • Typical project pitfalls will be discussed, and how these pits falls can be avoided using GMP project management