It is well understood that sterility of an aseptic product cannot be determined by direct assessment of the finished product. Therefore, microbiological safety of the product can only be achieved by careful assessment of the hazards and control measures in place to provide the confidence that the items are safe for the patient and fit for use.

Historically aseptic processes have relied heavily on monitoring of the environment, air, surfaces, and personnel to verify the success of the process. However, modern aseptic processes require a more holistic assessment of all the protective measures in place within the process and the complex interaction between these control measures, this approach is fully covered within this course.

We guarantee that on completion of this course, with the knowledge gained, you will look at aseptic processing from a new perspective. 

Honeyman is renowned for industry-leading GMP knowledge-transfer, lectures, consultancy, and courses delivered face-to-face. Our virtual training now helps you 'keep your space' and stay at the top of your game. 

Who should attend this course?

This course is suitable for all members of staff working with aseptic processes in sterile product manufacturing operations, including:

• QP’s and Quality
• Operational Managers
• Operations Personnel
• Technical and Engineering
• Validation

Course Objectives

• To understand the fundamental mechanisms of contamination transfer from source to product and the protective measures in place to prevent product contamination.
• To have the opportunity to work with risk management techniques like HACCP and RMC through practical workshops
• To understand the technology associated with cleanrooms and aseptic processes and understand the key control measures and they impact the sterility assurance of the product
• To introduce new thinking for validation and risk assessment of the process
• To understand the cGMP regulations and guidelines for aseptic processing and to engage in discussions regarding industry changes and best practice. 

Course Content

• The course programme includes:
• Risk Assessment in Aseptic Processing
  • HACCP and RMC Techniques 
• Pharmaceutical Microbiology
• Environmental Monitoring
  • Viable, Non-viable particles
• Bioburden Control & Sterility Assurance
• Methods of Sterilisation:
  • Moist Heat (Porous loads, SIP)
  • Filtration style
  • Dry Heat
• Methods of Decontamination - VHP
• Clean Utilities - WFI
• Cleanroom Design and Operation
• HEPA Filters 
• RABS & Isolator Technology 
• People as a Source of Contamination
• Effective Contamination control
• Aseptic Validation
• Process Simulation Tests 
• Aseptic Processing Guidelines and Regulations
• Regulatory Trends and Interpretations 

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