Bio-Contamination, Risk Profiling and Proactive Response
This webinar gives an overview of the recently released UK Pharmaceutical and Healthcare Science Society (PHSS) Technical Monograph #20 – Bio-contamination, characterization, control, monitoring and deviation management in controlled / GMP classified areas. The concept of Risk Profiling and Proactive Response (RPPR) to bio-contamination in GMP classified areas, focusing on preventing contamination and not just monitoring for compliance is presented. How trending environmental monitoring data holistically across all supporting areas can detect an increasing risk of a contamination event in Grade A zones is examined. In particular, the value of using real-time airborne viable particle detection as part of holistic monitoring strategy for risk escalation is discussed.
Many organisations are pro-actively exploring Rapid Microbiological Methods (RMMs). Real-time airborne viable particle counting is an RMM that is generating great interest. The potential opportunities of improved product quality and efficiencies, whilst maintaining patient safety are too significant to ignore. Cases where this technology is providing value today in a pharmaceutical manufacturing environment will be presented. Included is a brief discussion of critical performance characteristics of real-time viable particle detectors which should be considered when selecting an instrument to monitor GMP classified areas.
James Drinkwater, Chairman, PHSS
Environmental Bio-contamination control and monitoring: The PHSS – Pharmaceutical and Healthcare Sciences Society are releasing a new technical monograph covering the life cycle of Bio-contamination in controlled environments. The monograph is a first of its type in this field bringing together guidance across: Bio-contamination characterisation and risk profiling, Control; principles and guidance, Monitoring; including perspective on Rapid and Real time Micro Methods (R2MM) together with Deviation management: Investigations and CAPA: Corrective and preventative action.
James will highlight in this pharma webinar the key issues from the monograph relating to new initiatives, new practice and new technologies such as Real time micro monitoring systems that support a proactive response to risk escalation in contaminating critical areas and a holistic approach to trending of environmental monitoring data. The PHSS Bio-contamination monograph 20 has undertaken full regulatory review before publication.
Tim Russell, Product Specialist – Contamination Control, TSI
How Real-Time Airborne Viable Particle Counting delivers value today: everyday examples where real-time airborne viable particle counting technology is providing efficiency savings in a pharmaceutical manufacturing environment will be presented. How data gathered from real-time viable particle detectors in tandem with traditional methods is used to verify environmental air quality will also be shown. And, in what way real-time viable particle detectors are giving new perspectives on microbiological excursion root cause investigations. Tim will conclude this pharma webinar with a brief description of the technology, and discuss critical performance characteristics of real-time viable particle detectors which should be considered when selecting an instrument for your application.
Tim Russell has supplied and maintained optical particle counters for over 27 years. He was one of the founders of Facility Monitoring Systems Ltd., holding various positions until it was acquired by TSI in 2008. He is currently a Product Specialist for pharmaceutical and life science applications in the Contamination Control group at TSI Incorporated.
Supported by TSI
TSI Inc. serves a global market by investigating, identifying and solving measurement problems. As an industry leader in the design and production of precision measurement instruments, TSI partners with research institutions and customers around the world to set the standard for measurements relating to aerosol science, air flow, chemical analysis, indoor air quality, fluid dynamics, biohazard detection, and even scrap metal sorting and plastics identification.
Find out more: www.tsi.com