In this webinar you will learn:
I. How to ensure your disinfectant validation program is a success
• Learn disinfectant testing methodologies.
• Review “real world” examples of disinfectant efficacy tests.
• Increase awareness of pitfalls encountered during testing.
II. Troubleshooting problems related to disinfectant efficacy testing.
• Problems associated with porosity of substrates
• Neutralizers that are toxic to cells
• Recovery steps that give problematic results
• Discover the steps for success
III. Ensuring a Complete Validation Program
• Hard surface testing vs. suspension testing
• EM data trending
• In Situ Testing
• Meeting FDA, EMEA, and Japanese Commission Expectations
IV. Case Study
• Real world example of how disinfectants are validated
• How data from the laboratory is correlated to the real world
• Common issues that can be related to real world cleanrooms
V. Regulatory guidelines related to disinfectant validation
• USP 31 NF-26 General Chapter <1072>
• New Aseptic Processing guidelines (2004)
• ISO guidance documents (ISO 14698 parts 1-3)
• Other current guidance documents and trends
• Additional efficacy testing methods: CEN testing, AFNOR, DGHM, ASTM, AOAC, and TGA
I
nstructor: Jim Polarine