USP Chapter 800 presents many challenges for pharmacies and other health care settings, especially compounding pharmacies.
USP Chapter 800 presents many challenges for pharmacies and other health care settings, especially compounding pharmacies. Let’s review air flow requirements for the hazardous drug (HD) compounding area and “powder hoods” in nonsterile compounding of hazardous preparations as defined by the National Institute for Occupational Safety and Health.
Although the requirements are easy to understand and straightforward, accomplishing the requisite specifications can be challenging and requires meticulous guidance and planning, along with significant expense.
There are 2 air flow areas to be considered (see Section 5.3.1, Table 2, Engineering Controls for Nonsterile HD Compounding, in the USP Chapter <800> guidelines). The first is air flow for the hazardous room known as the Compounding Secondary Engineering Control (C-SEC) room. The second is air flow for “powder hoods” or the Compounding Primary Engineering Control (C-PEC) room (see Appendix 3, “Types of Biological Safety Cabinets,” in the USP Chapter <800> guidelines).
There are 4 primary requirements that must be addressed in the C-SEC room:
The standards regarding the C-SEC room are direct and, in theory, easy to implement. It is important to be familiar with the standards to be able to ascertain whether proposals meet the requirements. However, finding HVAC contractors familiar with their implementation and the appropriate equipment can pose a challenge. Equipment is available that will move air into and out of the room and provide a constant temperature in the room. At least 1 brand of unit that will meet the requirements exchanges a portion of the energy from the exhaust air to the intake air.
There are several considerations regarding the C-PEC room:
It is important that pharmacies fully ascertain and understand the requirements contained in USP Chapter 800 prior to implementation to ensure that changes comply with the accepted standards, resulting in increased safety for patients and personnel. USP Chapter 800 primarily focuses on the safety of personnel. Being familiar with the standards will allow pharmacies to meet the standards but also prevent them from unintentionally exceeding the standards, resulting in unnecessary expense.
Douglas C. Higgins, RPh, FIACP, is the owner of Doug’s Compounding Pharmacy in Paxton, Illinois.