At Hartley Medical, we strive to maintain the optimal environment for compounding sterile drugs. Long before the United States Pharmacopeia (USP) Chapter 797’s guidelines for sterile compounding were introduced, we initiated an effective environmental monitoring program that incorporates advanced technology.

It is important to understand value of Hartley Medical’s equipment associated with exceeding USP 797 regulations for the elimination of bacteria and inanimate microbial or inanimate particles for appropriate sterile compounding. USP 797 requires that pharmacies compound sterile products within a Class 100 environment. Classification 100 is an old standard of the Federal 209-E, stating air classifications of Class 1 through 1,000,000, calibrations and defining air cleanliness. Therefore, a Class 100 Laminar Air Flow Workbench (LAFW / IV Hoods) is defined as providing air quality with no more than a hundred 0.5 micron-size particles to be contained within a cubic foot of air. The ISO 9000 Publication has now revised those past standards, defining the new classification of ISO with a number between 1 and 10. The ISO standards stipulate that Class 100 filtration devices represent an ISO classification of 5. With regard to ISO 5 classification, the concentration of air particles cannot exceed 3,520 per cubic meter. The two standards are differentiated through conversion of particle content to the metric system.

At Hartley Medical, we utilize Class 10 IV hoods that deliver a filtration of no more than 10 particles per cubic foot. The average compounding pharmacy is utilizing Class 100 LAFW/IV Hoods. Our greater filtration capacity provides an optimum environment for sterile compounding and exceeds federal standards.

In addition, our IV hoods are tested for microbial and non-viable air particles. USP 797 states that sterile compounding pharmacies will certify the IV hoods every six months. However, at Hartley Medical we certify our IV hoods every 120 days to closely monitor their function and detect any problems in filtration sooner. For microbial testing we employ a Bioscience SAS 100 Air Sampler. This device will draw 1,000 liters of air across a growth medium plate, detecting the microbial load that could exist in the IV hood area.

At Hartley Medical, we are ahead of both federal and state guidelines affecting sterile compounding. Please review the Polyanalgesic Consensus Conference publication discussing pharmacy compounding and compare its standards with those of Hartley Medical.