#bio-contamination

Whether it is a new laboratory research facility or renovation of an existing facility, a sound commissioning process is vital to start-up success.  The commissioning process ensures that the facility and equipment within the facility are ready for occupancy and use.  Additionally, it ensures compliance with federal, state and local requirements.  Part of this process includes a post-construction biodecontamination of the facility to ensure the safe integration of workers and animals into the new space.  There are many factors that go into choosing the best method of biodecontamination.

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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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