Perkins&Will recently completed the renovation and expansion of a cGMP pharmacy at the National Institutes of Health Clinical Center in Bethesda, Maryland, which will support the medical center’s treatments that give new hope for patients and families fighting cancer and other diseases. The 15,000-square-foot pharmacy increases capacity and streamlines processes to meet inpatient and outpatient needs, marrying complex technology and building systems with human-centered design tailored around patients and staff needs.
The pharmacy supplies intravenous pharmaceuticals and biopharmaceutical products (including investigational new drugs) for patient care and research at the clinical center. To support this effort, a permanent intravenous admixture unit capable of supplying these needs is required within the NIH campus.
The new intravenous admixture unit facility has two main areas – the aseptic production facility and non-APF pharmacy. The APF area is divided into five main working spaces with applicable support facilities including gowning rooms, air locks, pass-throughs, drug storage, etc.
A total of 12 compounding rooms are provided constituting controlled aseptic environments in which the concentration of airborne particles is reduced by HEPA filtration, air locks, positive pressure ventilation and easily cleanable and decontaminated surfaces. A prefabricated wall and ceiling panels system with integrated windows for visual transparency and touchless operation doors has been utilized, allowing for maximum cleanability and durability.
Six of these clean room suites are designed to meet USP 797 standards for the compounding of pharmaceuticals with a focus on the protection of sterile compounds and environments from contamination while the balance is designed to meet USP 800 standards including two biosafety lab, level 2 suites, to ensure protection of healthcare workers and patients from exposure to hazardous drugs and microbes. The pharmacy also includes substance storage areas, prescription staging areas, outpatient dispensing, inpatient unit dose dispensing, tube stations, cart filling station, restrooms and storage areas consisting of controlled room temperature, refrigerated and minus -20C/-80C frozen storage.
The P-IVAU facility implements strategies in compliance with Chapter 13, Aseptic Production Facilities within the 2016 NIH Design Requirements Manual, as well as generally accepted pharmacy design principles, including best pharmacy and admixture practices.
