USP-Compliant Outpatient Center Renovation Part II

September 2017 - Vol.14 No. 9 - Page #18
Category: Cleanroom Design & Consulting

A pharmacy build or renovation is an exciting opportunity to create a USP-compliant compounding environment that will serve the hospital’s needs for years to come. With USP <800>’s enforcement date of July 1, 2018 less than 1 year away, building a new cleanroom or renovating existing pharmacies will be a significant focus of many health systems in the coming months.

The Valley Health System in northern New Jersey renovated its outpatient center pharmacy and designed and built a compliant cleanroom in late 2016. The goals of the renovation were to ensure the safety of its compounded sterile preparations (CSPs), become USP <797> and <800> compliant, increase the pharmacy’s size, improve efficiency and workflow, and create a collaborative work environment.

This process is detailed in the July 2017 Pharmacy Purchasing & Products article, Pharmacy Renovation: USP-Compliant Outpatient Center. While the July article focused on the renovation of the central pharmacy, anteroom, negative-pressure cleanroom, and the facility’s CSTD use, this article focuses on the implementation of medical-grade refrigeration, wireless temperature monitoring, communication tools, room pressure monitoring, and renovation of the nonhazardous sterile compounding cleanroom.

Medical-Grade Refrigerators with Wireless Temperature Monitoring

To ensure the integrity of costly oncology medications requiring refrigeration, these drugs are stored exclusively in medical-grade refrigerators monitored with a continuous wireless temperature monitoring (WTM) system. The number of refrigerators required was determined using past experience, with an eye toward ensuring sufficient capacity for anticipated future growth.

Communication Tools

Room Pressure Measurement

Non-HD Sterile Compounding Cleanroom
Click here to view PHOTOS 6-8

Ronald J. Krych, RPh, MPA, is the director of pharmacy at The Valley Hospital in Ridgewood, New Jersey.

Carlo Lupano, RPh, MBA, CCP, FASHP, is the pharmacy manager for ambulatory services at The Valley Hospital in Ridgewood, New Jersey.


  • Consultant: Eric Kastango, Clinical IQ, LLC
  • Casework: R.C. Smith/MMI Systems
  • CSTDS: ICU Medical, Inc
  • BSCs: The Baker Company
  • Cleanroom Controls: Designed by Rodney B. Strohl, Associate AIA, r4 Architects
  • Intercom: Aiphone Corporation
  • Medical-Grade Refrigerators: Follett LLC
  • Wireless Temperature Monitoring System: Primex Wireless, Inc
  • Documentation Software: Pharmacy OneSource's Simplifi 797
  • Pharmaceutical Waste Management Services: Stericycle, Inc


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