Location: London, United Kingdom
Our team will be speaking at Pharmaceutical Microbiology UK! This two day event brings industry experts together to discuss regulatory expectations on biocontamination control and monitoring in aseptic manufacturing. Discussions will also cover the impacts of the Annex 1 Revision as it relates to pharmaceutical microbiology and common myths of contamination control.
Don’t miss our technical expert, Jim Polarine as he discusses these highlighted topics!
Day 1 | 11:25
Panel Discussion: The Impact of the Annex 1 Revision on Pharmaceutical Microbiology
With Jim Polarine and other industry experts
This panel will discuss the following:
- Which RMM technologies are being used without regulatory conflict on microbiological sampling results - is industry ready for integration of digital platforms?
- The removal of contamination risk from operators through use of gloveless cells and robotics in filling platforms
- What does the unity of environmental classification, qualification and process monitoring mean to EM programs and data management of total particulate and microbiological samples?
- How do we manage risks associated with aseptic manufacturing of toxic and biologically hazardous products such as EM sample contamination, product cross contamination and personnel exposure?
- Assessing the disinfection rotation section on the use of multiple disinfectants to prevent the development of resistant strains
- Revisiting the potential latent risk of VBNC and stressed microbial contamination in sterile product manufacturing
Day 2 | 9:45
Common Myths and Urban Legends in the Pharmaceutical Industry Related to Contamination Control
With Jim Polarine
This session will discuss:
- Disinfectant Quantity - the misconception that more disinfecting agent is always better for sanitization of surfaces
- Microbiological Resistance - The misconception that microorganisms will develop resistance over time to the use of disinfectants
- Disinfection Rotation - the misconception that disinfection rotation is required to prevent microbiological resistance
- Effectiveness of Isopropyl Alcohol - The misconception that 70% Isopropyl Alcohol (IPA) is effective for control of fungal and bacterial spores