We will work with you to build into your existing space or create a new space, and take advantage of every possible feature, while adeptly handling any unique circumstance. Give us a call at 800-815-2726, fill out the USP 797 cleanroom worksheet or use the contact form for help with your cleanroom.
The United States Pharmacopeia (USP) requires pharmacists perform compounding operations in strictly mandated cleanroom conditions.
The USP 797 code spells out the requirements and procedures for standard compounding sterile preparations (CSPs). The USP 797 outline includes proper laminar flow, operation techniques, air and room cleanliness, and workstation placements. The USP 800 dictates further requirements for cleanrooms dealing with hazardous drugs or materials that require extra levels of safety and cleanliness. Additionally, individual governmental boards (such as state boards) can add to or elaborate upon the specificity and range of these regulations. .
Meeting the needs of these regulations within both the confines of physical space and budgeted dollars, can make creating a USP compliant cleanroom a challenging endeavor. Lasco Services offers over two decades of experience and a creative approach to tackle these challenges. Whether you need a gap analysis, complete design, full construction and/or cleanroom certification, we can help with the full spectrum of products and services.
USP 800, published in February of 2016, addresses the protection of health care workers, including pharmacists, from exposure to hazardous drugs. The hazardous drugs are not just the oncology drugs currently compounded in the “chemo” rooms of contemporary USP 797 pharmacies, but all those deemed so by NIOSH (National Institute for Occupational Safety and Health). Health care facilities have until July 1, 2018 to be in compliance with USP 800.