Cleanrooms are generally ubiquitous in those facilities making at least 50 CSPs per day. An increasing number of facilities are adding new cleanrooms, with stick built construction remaining the most popular approach followed by modular hardwall cleanrooms. Aging infrastructure is a concern, however, as half of the cleanrooms currently in use are more than 5 years old. Smaller facilities with low compounding volumes (<50 CSPs/day) are more likely to have older cleanrooms or no cleanroom at all. Looking ahead, the next 2 years are projected to be busy as many facilities are currently in the process of designing and installing new cleanrooms to meet USP’s December deadline.
Cleanroom adoptions continue to trend upward and are strongest in those states where <797> compliance is required: 80% of facilities in those states utilize a cleanroom with dedicated HEPA filtration; that number drops to 65% in states where <797> compliance is not required.
Smaller facilities face special challenges in complying with new regulations. A small majority (57%) of facilities compounding 50 or fewer CSPs per day do so in a cleanroom. As such, many of these facilities with smaller compounding volumes will need to rely on outsourced compounders to supply hazardous CSPs.
Half of all cleanrooms in the US are more than 5 years old, and may require updates in order to achieve full USP compliance. Notably, older cleanrooms are more likely to be concentrated in facilities with lower daily compounding volumes.
Among those facilities currently without a cleanroom or operating a cleanroom that is more than 5 years old, 65% are planning a cleanroom installation and just over half of those already have a new cleanroom in development.