Summary
The role of Vapour Phase Hydrogen peroxide VHP/vH2O2 as a process of bio-decontamination of controlled spaces in pharmaceutical applications has been well established in the pharmaceutical industry for many years. The published references to inactivation of many different microbial contaminants (individual isolates) and viruses, is broad, indicating the broad-spectrum efficacy of this sporicidal agent.
With such an established bio-decontamination method why then did the MHRA publish a Blog on ‘Fragility of VHP’? The key question to consider is whether the process itself is fragile, or if the process knowledge is insufficient. If the science and process are better understood the inherent complexities can be managed and the strengths of VHP/vH2O2 bio-decontamination realised with acceptance by all regulatory authorities.
This Master class will cover the science, mode of action, process application and inherent variabilities that need managing to assure successful and robust VHP/vH2O2 bio-decontamination cycles.
Who should attend?
Aseptic Process Engineers; Sterility Assurance Specialists; Quality Assurance (QA) and Quality Control (QC) Professionals; Regulatory Affairs Specialists and Auditors; Material Science and Technology (MS&T) Process Developers; Process Development Scientists; Microbiologists; Validation Engineers; Environmental Monitoring Specialists; Sterilization Specialists; Cleanroom Operators; Manufacturing Engineers; Technical Operations Managers; Biotech Engineers; Facility Managers in Pharmaceutical Manufacturing; Those involved in ATMP manufacturing where VHP/vH2O2 has the application of environmental viral clearance as part of viral containment strategies; People providing Quality oversight and who are Regulator/auditor facing; Those working with Isolators, Closed-RABS, or Cleanrooms
Learning Objectives
- Increase your knowledge on the science behind VHP/vH2O2 bio-decontamination process
- Understand process inherent variability in this Bi-Phasic process (gas and deposition phases)
- Understand the challenges in cycle development and qualification with biological indicators (BIs) and how to manage them
- Learn about the implementation of EIs (Enzymatic Indicators) alongside BIs
- Gain insights into optimizing bio-decontamination cycles for different environments and equipment types, including Isolators, RABS, and Cleanrooms
- Understand regulatory expectations and how to achieve compliance with global standards for bio-decontamination processes
Key Topics
- Science and Definitions, VHP mode of Action, Efficacy Challenge Testing
- Biological and Chemical Indicators
- Science: Gaseous Bio-Decontamination via VHP/vH2O2
- Bio-compatibility of VHP/vH2O2 with Biological Products and Supporting Analytical Impact Studies
- Gassing Cycle Development Methodology
- Performance Qualification of VHP Cycles and Re-qualification Requirements
- VHP Cycle Re-qualification Methodology and Root Cause Investigations in Cycle Failures
Our online training experience includes
- Our client zone – a single source for all training materials as well as pre and post-training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Revisit recorded sessions for 7 days
- Training in digital format
- Digital and LinkedIn certificates
Trainers
VHP/vH2O2 Bio-Decontamination Master Class
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
