#risk mitigate

With the product lifecycle moving so fast, many organizations may ask the question, "How can we effectively measure quality?" The answer is risk management. Learn the elements of risk management and how they help to identify, prevent, and mitigate risk throughout an organization.

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Pharmaceutical manufacturers often rely upon two reasons to justify the purchase of used equipment for their operations: lower prices and faster delivery. These reasons are not a secret; used pharmaceutical process and packaging equipment can usually be purchased at prices that are 50% to 80% cheaper than new equipment. The equipment is typically available immediately, cutting lead-time for delivery by months. Even with this simple value proposition — save time and money with used equipment — many pharmaceutical manufacturers have never considered used equipment or simply refuse to consider used equipment as an option.

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This white paper considers environmental monitoring and contamination control strategies using the benchmark hydrogen peroxide vapor (HPV) gaseous bio-decontamination process. Using best practice and the latest technology, significant efficiency savings can be identified at different process stages. Bio-contamination control, monitoring, and improving assurance

Bio-contamination control and monitoring Quality Risk Management (QRM) needs to consider the inefficiencies in microbiological monitoring. The forthcoming revisions to the ISO14698 standard on bio-contamination in cleanrooms and controlled areas and the USP<1116> microbiological control and monitoring of aseptic processing environment chapter, will place more emphasis on ‘contamination rates’. Without qualification, conventional bio-decontamination processes, typically called sanitization, require significant environmental monitoring to measure the impact on bio-contamination control. Such processes and monitoring strategies, using ‘Alert’ and ‘Action’ levels, are now under review. These reviews are challenging the efficiency to control and detect bio-contamination for contamination risk reduction.

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