Recognizing the value of environmental monitoring in maintaining a high-quality cleanroom environment, most hospital pharmacies are investing in a best practices approach to EM activities. Incubator use is becoming more prevalent in the pharmacy, requiring additional SOPs and the development of further expertise for the Designated Person.
This year saw a strong commitment to following best practices for surface sample collection, rather than simply meeting the minimum requirements. Surface samples are now collected at least monthly by 70% of all facilities, a 38% increase over last year’s numbers.
The vast majority of facilities have defined action levels in their EM plan, yet fewer facilities have defined alert levels.
Environmental monitoring processes are again becoming a pharmacy-centric activity with fewer facilities relying on outsourced service providers or certifiers given that these tasks now must be completed at a higher frequency. As such, it is imperative that pharmacy maintain the necessary expertise to conduct these processes in-house.
Among those pharmacies conducting their environmental monitoring in-house, an increasing number are utilizing their own incubators rather than relying on the laboratory’s existing equipment. Last year, 51% of pharmacies had their own incubators; this year 59% are taking this approach.
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Thermo Fisher, Health Care Logistics, QI Medical, and Baker are the leading providers of incubators within pharmacy.
Just under 90% of incubators used for environmental monitoring have temperature monitoring in place that is documented daily.
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