Does USP <797> require construction of a sophisticated cleanroom?
No. The short answer is that <797> requires sterile mixing in a properly maintained laminar airflow hood (ISO Class 5 – also known as Federal Standard Class 100, or a maximum of 100 particles per cubic foot) situated in a relatively clean room (ISO Class 7 – also known as Federal Standard Class 10,000). In other words, sterile compounding must take place in a controlled area that meets a defined level of cleanliness under dynamic conditions. For most pharmacies, this is neither a difficult, nor unreasonable expectation.
