Product Spotlight: Misterium Cleanroom from Grifols USA


February 2018 - Vol. 15 No. 2 - Page #22

Kingman Regional Medical Center (KRMC) is a 235-bed hospital that provides acute and ambulatory services in northwest Arizona. As a nonprofit community and teaching hospital, KRMC strives to provide the region with excellent clinical care and patient service. The pharmacy department has grown considerably in recent years to support the needs of the hospital and community.

Over the past year, the pharmacy staff has expanded by 25% across both ambulatory and inpatient acute care services. The growth has been driven in part by the pharmacy-run Disease Management Clinic. This ambulatory, provider-based clinic is run by pharmacists operating through a collaborative practice agreement with KRMC providers. Its mission is to identify and assist patients who require special attention to meet their care plan compliance and avert the risk of readmissions. In addition, KRMC undertook the construction of a new oncology outpatient infusion center and dispensing satellite. Given this broad expansion, pharmacy leadership’s goal is to recruit and retain highly talented pharmacists and technicians; adopting quality automation and equipment is essential to meeting this goal.

Selecting a Cleanroom Solution

As part of creating a new outpatient infusion center, a cleanroom renovation was necessary to build a compliant space to handle both hazardous and nonhazardous compounded sterile preparations (CSPs). From a regulatory perspective, we were committed to meeting the requirements of our state board and accreditor, which meant complying with USP <795>, <797>, and <800>. During the planning process, we considered lines of sight, workflow, materials management, and ease of cleaning. It became clear that the proper environment was the linchpin for establishing an exceptional cleanroom. Once correct engineering controls are established, staff training, certification, environmental monitoring, cleaning, and technology-based workflows can be implemented to support safe and efficient CSP compounding.

To address these needs, we researched Grifols’ Misterium modular cleanroom and PhocusRx workflow management system. It became evident that both of these products would benefit our compounding program. In selecting a vendor, it is important to choose a company that provides exceptional customer service as well as strong business outcomes. Grifols has a longstanding reputation for both, which prompted further evaluation of their cleanroom products.

Product selection at KRMC takes into account the product or service’s price, implementation timeline, and its relevance to operations. These factors are reviewed, approved, and accounted for in the operational budget. The installation of a new cleanroom was part of a budgeted department renovation.

In addition to maintaining the integrity of the space, the modular design of the Misterium cleanroom system allows for maximum flexibility in post-project modification. Should the pharmacy department need to relocate within the hospital facility, the Misterium cleanroom can be transported and re-established in a new working environment. The quality of the materials used to manufacture the Misterium cleanroom is another beneficial feature; the walls, floors, and ceiling are durable, and the system is easy to clean.

The sterile product workflow in the new cleanroom is driven by Phocus Rx, a noninvasive workflow management system. The technology allows for remote validation and documentation of sterile compounding processes. Image capture improves quality control, ensuring proper compounding by technicians and thorough validation by pharmacists. Phocus Rx is capable of interfacing with a variety of other technologies to support efficient workflow; integration with the electronic health record (EHR) is particularly helpful.

Looking Ahead

The process of installing the cleanroom and bringing the workflow management system online was well executed with support from Grifols. Future workflow will be even more streamlined; presently, when a label dispenses, it is scanned and then uploaded into the Phocus Rx working queue. Our plan is to utilize the Phocus Rx interface with our EHR, thus bypassing the scanning step. As such, verified orders will automatically enter the Phocus Rx queue, allowing technicians to instantly begin preparation.

During KRMC’s first cleanroom project with Grifols, our pharmacy team recommended that a foot pedal be added to assist with sterile product image capture and processing. KRMC is currently undertaking a second cleanroom project with Grifols, and we are pleased to see that the foot pedal option is now available. This demonstrates the vendor’s dedication to improving their product, as well as their focus on the end users’ experience.

An exceptional compounding operation that complies with USP standards cannot exist without first establishing the appropriate environment. Misterium and Phocus Rx deliver a highly functional, compliant environment that is easy to maintain and serves as the foundation of our compounding operation.


Jason Harsanye, PharmD, MBA, is the pharmacy operations manager at Kingman Regional Medical Center in Kingman, Arizona. He received his doctor of pharmacy degree from the University of Findlay in Findlay, Ohio, and his MBA from Cleveland State University. Jason’s professional interests include strategic planning and operations management, new business development, project management, Lean Six Sigma, finance and accounting, and supply chain management.

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