Once the cleanroom is constructed, SOPs established, and personnel are trained, environmental monitoring serves as the linchpin to ensuring the ongoing safety of CSP production. With effective environmental monitoring, practice drift can be identified before it becomes a threat to patient safety. As such, it is concerning that environmental monitoring is not universally implemented. Low volume compounding does not imply a reason to avoid these requirements. Facilities reporting low levels of USP compliance are the least likely to conduct consistent environmental monitoring, which raises serious concerns.
The number of facilities with an environmental monitoring plan in place remained flat this year at 79% overall. Compounding volume has a notable effect on this metric, as facilities producing fewer than 50 CSPs per day are significantly less likely to have a plan in place.
While most facilities without a plan in place expect to implement one within the next 2 years, it is quite concerning that one-third of facilities without a plan are not looking to establish formal environmental monitoring.
QI Medical continues to lead this market segment, along with BD and Hardy Diagnostics.
A variety of tools are utilized for environmental monitoring, with plates being the most popular. Just over half of facilities are conducting their own air sampling tests, while many facilities rely on their certifier to complete these tests during their biannual visits.
Environmental monitoring equipment delivers strong satisfaction; 99% of users are satisfied with their chosen products.
Two-thirds of facilities continue to conduct their environmental monitoring in-house; 46% of those facilities utilize laboratory incubators to process the samples, while 45% have invested in incubators for the pharmacy.
Satisfaction with environmental monitoring processes correlates to <797> compliance. Facilities with low compliance to <797> are less satisfied with their environmental monitoring processes.