Mobile Compounding Pharmacies for USP 797 & USP 800 Compliance
The remodeling of an I.V. pharmacy presents a range of potentially difficult or costly challenges. During building renovations it is imperative that compounding operations are not interrupted or otherwise negatively impacted. Insuring the integrity of USP 797 and USP 800 compliance is critical to maintain an environment for safe and aseptic compounding.
Turnkey Rental Pharmacy/Cleanroom for Hospital Facility Renovations
Germfree’s certified USP 797/800 mobile pharmacies are delivered to your facility in coordination with your construction schedule. These turnkey facilities, integrated into a mobile platform, provide the ideal solution for seamlessly maintaining pharmacy services during your renovation. Germfree’s Compounding Pharmacy Rental/Lease Program allows for a smooth transition during all phases of your project.
Germfree’s mobile pharmacies may also play a critical role in continuing USP 797/800 operations during emergencies or after a natural disaster. Our units can be equipped with emergency generators to be sustainable when regular facility power is interrupted. Germfree’s rental pharmacies are also capable of providing surge capacity for adding compounding resources to your existing operations.
Germfree’s Compounding Pharmacies are Designed with 3 Distinct Work Zones:
ISO Class 7/8 Anterooms:
This room serves as an antechamber and as a changing area for personnel to don their Personal Protective Equipment (PPE). The area is equipped with lockers for storing PPE, a hand washing sink and a gowning bench. The anteroom is maintained at positive pressure relative to the outside. Pressure gauges over doors display room pressures, and have alarms to indicate unsafe conditions due to changes in the differential pressures between the rooms.
ISO Class 7 Negative Pressure Buffer Room:
This Hazardous Drug Preparation area is engineered as an ISO 7 environment. The room is equipped with Class II, Type A Biological Safety Cabinets to protect the product and personnel while preparing hazardous drugs. Ample storage space is provided by the custom casework as well as an integrated refrigerator and freezer. The preparation areas consist of stainless steel countertops with seamless welds, coved corners and radiused edges.
ISO Class 7 Positive Pressure Buffer Room:
This Sterile I.V. Preparation room is engineered as an ISO 7 environment and is equipped with Laminar Airflow Workstations to protect the product during aseptic preparations. Ample storage is provided by both the custom casework and the integrated refrigerator and freezer. The preparation areas consist of stainless steel countertops with seamless welds, coved corners and radiused edges.
Office Area: Additionally, the facility includes an entry/office area. The main entrance door is equipped with the proper security for your application.
Advanced Design and Engineering
Germfree Mobile Pharmacies Provide for Maximum Flexibility of Operations and Efficient Workflow. Our units are engineered with enhanced ergonomics for ease of use and maximum user comfort.
Flexibility of Operations: Our mobile pharmacies are designed by a team of I.V. pharmacy experts to provide the optimal aseptic compounding space for work with both hazardous and non-hazardous materials. This allows the facility to be effectively utilized for all USP 797/800 compounding requirements.
Efficient Workflow: Germfree’s compounding I.V. pharmacies are engineered and equipped for the most efficient workflow. The facility is divided into designated work zones. Each zone provides the level of HEPA-filtered air and the equipment required for your current process. Additionally, we strategically place Chemo Hoods, Laminar Flow Workstations, storage and supply areas, gowning benches and staging tables.
Enhanced Ergonomics: Hoods and workstations (primary engineering controls) and all other fixtures are designed for ease of use and maximum operator comfort.
USP 797/USP 800, NIOSH: Germfree’s turnkey Mobile Pharmacy/Cleanrooms meet or exceed the requirements of the USP Chapter 797 Pharmaceutical Compounding-Sterile Preparations and USP 800 Chapter for handling hazardous drugs. Our units comply with NIOSH recommendations for pharmacy practices. The pharmacy is tested to meet the guidelines within CETA CAG-003-2006 Certification Guide for Sterile Compounding Facilities.
Additionally, Germfree’s pharmacies meet the latest cleanroom requirements with low wall return. The units are engineered for precise HVAC, airflow, air pressure, balance strategies, and proper positioning of primary engineering controls within the cleanroom.
Certification and Complete Sterilization of Facility: Germfree provides VHP gas sterilization and verification prior to delivery to your site. Once the Rental/Lease Pharmacy is placed on-site, certification is performed according to all relevant guidelines. This includes specific testing and certification of the cleanroom areas as well as all Biological Safety Cabinets and Clean Air Workstations.
Interior Finishes and Casework
The interior walls are Arcoplast, a high performance composite that provides a seamless interior suitable for frequent wash-downs with sanitizing agents as well as gas decontamination. The floor is seamless vinyl, coved up the walls for ease-of-cleaning.
All work surfaces are seamless stainless steel with casework designed for gas and vapor phase decontamination. Surfaces are coved for easy spill cleanup and sanitization. Edges are rounded and polished to avoid snagging Personal Protection Equipment (PPE).
Mechanical, Electrical, and Plumbing (MEP) Systems and Utilities
Mechanical: A heating, ventilation and air conditioning (HVAC) system is installed in the unit. The HVAC system is engineered to maintain a comfortable working temperature and humidity level in the pharmacy.
Electrical: Connections for utility power and/or auxiliary generator inputs are provided with 50-foot long connection cables. An optional external diesel electrical generator package is available.
Plumbing: The plumbing system includes an on-board fresh water tank and an on-demand electric water pump to provide running water for a sink and eyewash station. The capacity of the laboratory water tank is supplemented by a connection to a water utility tap.
A gray water tank is designed to be gravity drained. The pharmacy cleanroom will arrive completely plumbed, ready for connection to water supply and drain lines.
Communication Ports: Data ports are provided for network instruments, computer workstations and printers. Cables are run in shielded chases to a patch panel in the anteroom. Telephone ports are provided in the anteroom.
Cameras and Monitors: Digital video cameras and a digital video recorder (DVR) provide perimeter security.
Training: Germfree offers on-site installation supervision as well as operator and maintenance training.