Given the continued improvements in equipment available for microbiological airborne monitoring, changes in usage/needs at a facility, and cost/availability considerations to name a few, it may be desirable to change from one air sampler to another.
Since it has not been possible to establish a direct correlation between the results of different air samplers due to a variety of technical issues, the question arises as to how to make the switch. Clearly, in an ongoing operation it is imperative to have as little downtime as possible while maintaining adequate monitoring data to ensure product quality. However, data generated with one instrument cannot be directly correlated with data generated by another instrument. Thus, the dilemma: how to continue operations and yet change over to another air sampler.
Product release must not be jeopardized during the transition. This is of particular concern in the pharmaceutical, biotechnology, and medical device industries due to the overriding need to meet regulatory expectations as well as company policies. Therefore, an adequate plan must be developed to ensure that sufficient data exist to support product manufacture while generating new data with a new air sampler. This can be accomplished by instituting parallel monitoring with both the old and new air samplers for a specified period of time. Developing a protocol prior to the changeover is key to ensuring that all considerations are addressed. This protocol should include, at a minimum, the following:
• Installation Qualification (IQ) and Operational Qualification (OQ) of each new instrument
• a plan for gathering data with the new instrument over the entire area surrounding the process being monitored, as well as at routine monitoring locations currently in use
• criteria for deciding when adequate data are available to monitor with the new instrument only and to support the continued use of routine monitoring locations
After executing the pre-approved protocol and reviewing the data generated with respect to the stated acceptance criteria, a final plan can be instituted for eliminating routine monitoring using the old instrument and continuing monitoring with only the new instrument.
Although a change of microbiological air sampler is less than straight forward, it can be readily accomplished and, if carried out appropriately with adequate documentation, will allow production operations to continue while generating the data necessary to support the new monitoring program.
James F. Quebbeman is currently Senior Auditor in the Corporate Quality Assurance Department at Pfizer and, until recently, was Senior Manager, Worldwide GMP Compliance at Parke-Davis Pharmaceutical Research, a Division of Warner-Lambert Company. He holds degrees in Cellular Biology, Physiology, and Microbiology. His experience includes laboratory operations for research, clinical, manufacturing, contract testing applications, and both development/clinical trial materials manufacturing and commercial operations for pharmaceuticals and biotechnology products. In prior positions, he was a consultant in technical and regulatory compliance issues, including design, validation, operation and testing of environmentally controlled facilities, and validation of critical systems and process equipment for pharmaceutical, biotechnology, and biomedical applications in the U.S. and Europe. James F. Quebbeman, M.S., M.A.
From Bioscience World, Autumn 2001
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