Germfree has been providing equipment for compounding sterile IV and hazardous drug preparations to the hospital pharmacy industry since the early 1970’s. Germfree’s HEPA filtered, unidirectional airflow equipment, also called Primary Engineering Controls (PEC), provide an aseptic environment that allows the pharmacist to handle sterile products in a contamination-free environment. As regulations in the hospital pharmacy have evolved, a shift toward placing PECs into ISO 7 Cleanrooms (Secondary Engineering Control (SEC) has occurred. The United States Pharmacopeia (USP) ‘Guidelines for Pharmaceutical Compounding – Sterile Preparations’ (USP 797) and ‘Hazardous Drugs – Handling in a Healthcare Setting’ (USP 800) define the requirements for these SECs and PECs.
Controlled Environments spoke with Jeff Serle, Senior Vice President/Chief Design Engineer of the Mobile Pharmacy Trailer, about the use of the mobile cleanroom facility.
Controlled Environments (CE): What led to the need for this cleanroom facility?
Jeff Serle (JS): Regulations in the hospital and healthcare pharmacy have evolved significantly, especially over the last 12+ years. These regulatory changes have impacted the demand for cleanrooms needed to prepare sterile IV preparations. When hospitals renovate their facilities to augment, add or improve cleanroom space, compounding operations must continue without interruption. Germfree developed the Mobile Pharmacy Trailer (MPT), the first USP 797/USP 800-compliant mobile cleanroom to allow for seamless drug compounding operations during hospital renovations.
CE: Who was involved in designing it?
JS: The MPT Cleanroom facilities were designed by our in-house engineering and design teams, with input from the user community (hospital pharmacists) and the cleanroom testing community, including the Controlled Environment Testing Association (CETA) certifiers. The design was based on the requirements of USP <797> and USP <800>, with an eye on State Board of Pharmacies, who can adopt USP guidelines into law or develop their own guidelines, which may or may not be directly in alignment with the USP guidelines.
CE: What challenges were faced along the way?
JS: We faced a couple of challenges in the development of the MPT. Our engineering team’s biggest challenge was designing the environmental control system that can maintain the demanding indoor air requirements in a hospital pharmacy across the varied climatic conditions experienced in the U.S. From a process side, a key challenge for us was to develop a standard product, the MPT, that would satisfy the regulatory requirements of each state.
The challenge to develop the MPT cleanroom was a natural fit for our design and engineering teams. We utilized our experience in manufacturing high containment mobile laboratories and our background in Primary Engineering Controls (PECs) to create this new type of flexible cleanroom to fulfill a critical need.
CE: Can you comment on the size and cost?
JS: The Hospital Pharmacy Cleanroom is built around a Germfree-specified version of a semi-trailer platform suited for the extensive modifications required to create the critical interior cleanroom environments (zones). The overall trailer is 8.5’ wide x 13.5’ tall x 53’ long (plus an additional 2’ for the redundant Environmental Control Units ECUs). Cost for these units varies based on duration of use or special requirements. The price includes all the equipment required to operate a hospital pharmacy, including the primary containment devices, also manufactured by Germfree.
CE: Who will be utilizing this space?
JS: The space will typically be used by a hospital pharmacy for their compounding sterile operations. The cleanroom can accommodate a hospital pharmacist and three to four technicians during a normal shift and operates 24 hours a day, seven days a week. The units can also solve space constraints or surge capacity demands on a healthcare facility. The MPT is also an option for cancer treatment centers, as well as use for clinical drug trials.
CE: Will this be a temporary or permanent fixture on the campus?
JS: The Hospital Pharmacy Cleanroom Trailer is designed as a temporary cleanroom space, which can be relocated for use at multiple facilities during construction/remodeling or as an emergency relief platform. We maintain a fleet of MPTs that are available for short-term lease. MPTs can also be purchased for longer-term projects or by healthcare systems with multiple locations.
Germfree has developed a specific set of quality control and decontamination procedures that are implemented between each new deployment. The unit is also tested and qualified by a third-party certification professional, typically accredited by the CETA National Board of Testing, prior to use at a new site.
CE: What does the future hold for this technology?
JS: Hospital and healthcare facilities will continue to find applications where the MPT can fill a gap in cleanroom capacity. Practitioners, process engineers and researchers are now able to see that a viable, advanced cleanroom space can be built into a mobile platform. This creates the next-level in rapid deployment and flexibility.
In other sectors, we currently provide similar units used by pharmaceutical manufacturing companies for applications ranging from production of FDA-approved drugs for human use, manufacturing drugs for clinical trials as well as training and evaluation of personnel that operate within these critical environments. As the industry transitions toward emerging biopharmaceutical therapies and small-batch personalized medicine, Germfree’s Mobile BioPharmaceutical Cleanroom Trailers will provide a flexible bioproduction platform. This will help companies dramatically reduce the time to gain regulatory approval for innovative new therapies.