Medical Construction & Design

NOV-DEC 2017

Medical Construction & Design (MCD) is the industry's leading source for news and information and reaches all disciplines involved in the healthcare construction and design process.

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20 Medical Construction & Design | NOV EMBER / DECEMBER 2017 | MCDM AG.COM Healthcare HVAC Spotlight Handling hazardous drugs puts healthcare workers in close contact with chemicals associated with serious health risks. Without proper precau- tions, clinicians who work with hazardous drugs are at increased risk of infertility, spontaneous abortions, con- genital malformations, cancer and immune disorders. Until recently, the na- tional standards that regulate the design and operation of compounding pharmacies have not discriminated between hazardous drugs and non- hazardous drugs. This changes in July 2018, when pharmacies in the United States will need to comply with USP 800, the United States Pharmacopeial Convention's new guidelines on the handling of hazardous drugs in healthcare settings. In essence, USP will have a signifi - cant impact on the HVAC needs of compounding pharmacies. USP 800 at a glance USP 800 builds on two stan- dards, USP 795 and USP 797, adding a crucial distinction be- tween hazardous and non-haz- ardous drugs. Under the new guidelines, hazardous drugs must be unpacked, stored and prepared separately from non- hazardous drugs. It requires: > A separate, non-positive space for unpacking hazard- ous drugs from their shipping containers > A dedicated, externally ven- tilated negative-pressure space for preparing hazardous drugs > A separate, externally venti- lated negative-pressure space for storage of hazardous drugs Each of these spaces has diff erent requirements for the degree of pressurization, the number of air changes per hour, the equipment required and the pressurization of adjacent rooms, which will be detailed below. The previously mandated separation of sterile and non- sterile drug-compounding areas will need to be maintained, but modifi ed to accommodate new air-handling requirements. Detail 1: Unpacking space USP 800's requirements for unpacking spaces are rela- tively simple. No air change rate or pressure diff erential is specifi ed, meaning it can be done in a pressure-neutral or negative space. Because pharmacies are typically designed at a positive pressurization, a new space for unpacking will likely have to be found. (Note: unpack- ing in the negative-pressure hazardous-drug buff er room is not an option because of po- tential contamination of sterile surfaces). Detail 2: Compounding room Under USP 800, hazardous- drug compounding must take place in a containment primary engineering control (C-PEC), or hood, located in a dedicated secondary engineering control (SEC) room, or buff er room that is externally ventilated, physically separated from other areas and maintained at a negative pressure between .01 and .03 inches of water, and at least 12 ACH and up to 30 ACH for sterile process- ing requirements. The buff er room requires access through a pressure-positive, ISO Class 7 anteroom, for sterile com- pounding. Under USP 797, most com- pounding pharmacies process hazardous drugs and non-haz- ardous drugs in the same room. For those facilities, compliance with USP 800 will require adding a negative buff er room for sterile hazardous-drug compounding. Although sterile and non-sterile hazardous-drug processing can occur in the same buff er room, USP 800 requires that the PEC used for non-sterile compounding not aff ect the ISO rating of the room. Because of the chal- lenges associated with this it is recommended that they are prepared separately. Facilities that process both sterile HDs and sterile non- hazardous drugs will need two BY KIM COWMAN Getting ready for USP 800 New national standard for handling hazardous drugs will aff ect the infrastructure needs of compounding pharmacies Photo: Gary Van Wyk/Dreamstime

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