Balancing Project Costs, Logistics with Updates to USP 797/800 Standards for Sterile Compounding Environments

One of the biggest challenges facing compounding pharmacies and medical facilities nationwide is the Dec. 1 deadline for complying with the structural and operational changes set forth by The United States Pharmacopeia’s updated USP 797 Pharmaceutical Compounding – Sterile Preparations and revised USP 800 General Chapter standards. The good news is there are proven, cost-reduction and time-saving solutions available to commercial architects and specification professionals faced with balancing the project costs and logistics with USP’s updated standards mandating enhanced engineering and procedural controls to protect operators and environments when packaging, handling and compounding hazardous substances.

Due to the health concerns of exposure to hazardous drugs such, as compounded pharmaceuticals, USP has mandated strict standards for the placement and utilization of an ADA-compliant hand-washing sink with an integral eyewash station in facilities conducting sterile compounding, such as in hospital pharmacies, inpatient treatment centers, institutional and government facilities. Selecting and configuring the hand-wash/eyewash sink precisely to fit the layout and dimensions of the positive anteroom adjacent to HD compounding areas as required under USP’s standards is a meticulous and time-consuming process.  For example, USP 797, which provides protection for sterile compounding activities and their environments from contamination, calls for precise placement of an eyewashing station within the positive anteroom sink. Per the USP standard, a sink must be available for hand-washing and an eyewash station and/or other emergency or safety precautions that meet applicable laws and regulations must be readily available. These are required on a national level in pharmacies where certain pharmaceutical compounds are produced.

ADA-compliant wall-mount hand-washing sink with swing down eyewash and sensor faucet.

Another important issue is the location of hand-washing sinks in pharmaceutical compounding operations. According to American Society of Health-System Pharmacists, in facilities with cleanroom suites, the sink used for hand hygiene may be placed either inside or outside of the anteroom. If the sink is located outside of the anteroom, it must be located in a clean space to minimize the risk of bringing contaminants into the anteroom. Sinks are permitted outside of the anteroom to offer more flexibility to the cleanroom design and help minimize the risk of contamination from water sources to the classified areas. In facilities preparing HDs in a cleanroom suite, General Chapter 800, which provides protection for healthcare workers, patients and environments against hazardous drug compounds, requires the sink to be placed in the anteroom at least 1 meter away from the entrance of the HD buffer room to avoid contamination migration into the negative pressure HD buffer room. There are no conflicts for the sink placement in 797/800 because facilities compounding sterile HDs must meet the requirements in both.

Furthermore, USP 797 specifies when hand-washing should occur in the gowning procedure. This requires a line of demarcation within the anteroom, separating the anteroom into clean and dirty areas across which shoe covers must be donned with hand-washing and further gowning on the clean side. Many designs place the sink on the “dirty” side of the line of demarcation to keep the sink the required 1 meter from the HD buffer room door, but this does not allow for the proper gowning procedures. If this is the case, the compounding pharmacy, research or medical facility may need to expand the size of their anteroom to have enough room to relocate the sink so proper gowning procedures can be followed.

The clock is ticking for thousands of healthcare businesses and research organizations nationwide as they invest in comprehensive renovations or the construction of new facilities specifically designed for conducting sterile compounding in the future. Is your facility ready?

Photo courtesy of Just Manufacturing.

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Posted August 12, 2019

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