Hospital Pharmacy Implements New Approach to
Uninterrupted Sterile Drug Compounding
US Healthcare Facility First to Use Certified Mobile USP 797 Cleanroom
During Major Hospital Pharmacy Renovation
RALEIGH, NC, Updated: September 29th, 2015 — Duke Raleigh Hospital recently became the first healthcare facility to utilize a certified USP 797 mobile cleanroom to assure uninterrupted pharmacy services. The advanced pharmacy unit, created by Germfree Labs, allowed the hospital to maintain separate, on-site sterile drug compounding operations during a major renovation project.
During building renovations it is imperative that IV compounding operations are not interrupted or otherwise negatively impacted. Full compliance with all regulations is critical to ensure an environment for safe and aseptic compounding of pharmaceuticals. Duke Raleigh worked with Germfree, the Florida manufacturer of the turnkey mobile USP 797 pharmacy-cleanroom. The fully equipped unit was engineered to provide the advanced functionality and ample capacity required for a hospital compounding operation.
“The mobile pharmacy was the perfect platform to continue all operations on-site,” according to Gene Woodall, Duke Raleigh’s Director of Pharmacy. “We were able to deliver vital sterile compounded preparations without interruption while maintaining our extensive quality assurance protocols and rigorous standards for product sterility. Concurrently, renovations to improve our main facility commenced with absolutely no impact on compounding services.”
The remodeling of a hospital pharmacy presents a range of difficult challenges to maintaining sterile drug compounding operations. “Traditional approaches are cumbersome and costly,” according to Sal Golfo, General Manager of Germfree’s Pharmacy Division. Some facilities are forced to renovate one section at a time, extending and complicating the project. Other hospitals resort to outsourcing their compounding, which adds cost and impedes workflow.
“Our challenge was to design and deliver a complete mobile pharmacy that would be immediately operational. It was imperative that the unit provide a comfortable workspace equipped to facilitate all sterile or hazardous drug services conducted in a traditional building,” said Golfo. The mobile pharmacy has distinct, controlled work zones engineered as ISO 7 environments. The Hazardous Drug Preparation Room operates under negative pressure and is equipped with Class II Biological Safety Cabinets. The Sterile IV Preparation Room operates under positive pressure and is equipped with Laminar Flow Workstations.
“During the initial planning of our renovation project, we knew we needed an innovative plan to maintain the output levels and quality standards required for our sterile compounding services,” said Gene Woodall. “Germfree’s mobile pharmacy provided an advanced, comprehensive unit with all the resources we needed to provide seamless sterile compounding during the renovations at Duke Raleigh Hospital.”
About Duke Raleigh Hospital
Duke Raleigh Hospital, a part of the world-renowned Duke University Health System, is a 186-bed acute-care facility in Raleigh, North Carolina with services including a cancer center, orthopaedic center, diabetes center, wound healing center, 24-hour emergency department, intensive and critical care, cardiovascular center, cardiac and pulmonary rehab, wellness services and community education. The hospital’s affiliation with one of the country’s best health systems provides patients with access to the most advanced technology and leading-edge medicine available. For more information visit: www.dukeraleighhospital.org
Germfree was established in 1962 by Jerome Landy, M.D., Ph.D, a physician and researcher. Dr. Landy originally started the company to create the biological safety equipment he needed for his research. Today, Germfree’s Pharmacy Division manufactures a wide range of safety equipment for the hospital pharmacy. Additionally the company has developed many new biocontainment technologies. Germfree is an industry leader in the manufacture of mobile life science laboratories as well mobile compounding pharmacy cleanrooms. For more information visit: www.germfree.com
Previous Press Release
New Facility to Detect and Respond to Outbreaks of Infectious Disease
Advanced Disease Surveillance: Regional Lab Will Boost Global Biological Security
PORT OF SPAIN, Trinidad and Tobago, MAY 20, 2014 — A new biological containment laboratory has been officially handed over by the Government of Canada to the Caribbean Public Health Agency (CARPHA). The Biosafety Level 3 facility is the first of its kind for the Caribbean region. Manufactured by Germfree, the facility was provided by Canada to CARPHA in cooperation with the Pan-American Health Organization(PAHO)/World Health Organization (WHO). The lab will provide new capabilities to rapidly detect and respond to outbreaks of disease, whether naturally occurring or deliberately caused.
“In our modern age, where global travel is routine and disease knows no boundaries, a well-equipped, safe and secure biological laboratory is an essential tool in the fight against infectious disease.” said His Excellency Mr. Gérard Latulippe, High Commissioner for Canada to Trinidad & Tobago, at the recent laboratory handover event. “As underscored by ongoing outbreaks of diseases such as the Chikungunya here in the Caribbean, as well as Ebola in West Africa, and the Middle East Respiratory Syndrome (MERS) in the Middle East, isolated disease threats can very quickly become regional or global menaces, presenting serious threats to the health, safety and security of the people of the world.”
The biocontainment facility is an initiative of the Biological Security program of Canada’s Global Partnership Program (GPP), which “works to prevent terrorists and states of concern from acquiring or developing biological weapons and related materials, equipment, and technology.” GPP’s initiatives include programs to: “Detect and report deliberately caused disease by strengthening regional and sub-regional disease surveillance and detection networks, supporting the gathering of epidemic intelligence and broadening international disease reporting networks”.
“When Germfree was approached by Canada’s Global Partnership Program, we were excited to collaborate on this important international project. We worked closely with Canada’s experts in biocontainment engineering and biosecurity.” said Jeff Serle, General Manager of Germfree, US manufacturer of the lab. “GPP challenged us to be creative and innovative in our approach. Energy savings, maintainability and sustainability were key goals for the CARPHA lab.”
“Currently there are several public health events of international concern.” said Dr. Yitades Gebre, Advisor on Family Health and Disease Management, PAHO/WHO. Dr. Gebre referred to reported outbreaks such as Chikungunya virus in the Caribbean, Ebola in West Africa and MERS Coronavirus in the Middle East when speaking at the laboratory handover. “In this regard, having proper laboratory support and services is paramount.”
Developing the ‘Health-Security Interface’: Threats to global health security can emerge as natural epidemics or deliberate biological attacks. The new biocontainment facility provides the capabilities required for both areas of concern. “A strong global partnership is required at the ‘health-security interface’, that broad area that exists between natural and deliberate disease.” says Mr. Latulippe. “The tools, infrastructure and capacities required to accomplish both health and security objectives are the same.” Noting the global impact of regional labs, The High Commissioner added, “No country or region, irrespective of its size or location, is immune to these challenges.”
The biocontainment lab is set up to rapidly identify samples suspected for a diverse range of diseases – including Yellow fever, West Nile virus, Rabies, Hantavirus, Anthrax, drug resistant MTB and emerging infectious diseases with epidemic potential. Advanced containment systems allow personnel to handle other biological-risk agents and materials of unknown origin. Regional biocontainment laboratories play a critical international role. According to Dr. C. James Hospedales, Executive Director of CARPHA, “This is a strategic public health resource for the Americas and the world.”
For additional information please contact: Craig Landy – [email protected]
+1 386-265-4300 Direct: +1 312-238-9785 +1 386-316-2799
Additional remarks and media resources for this news release are available here