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.
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.
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.
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.
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).
The preparation areas consist of stainless steel countertops with seamless welds, coved corners and radiused edges.
Mechanical Specifications: 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.
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.
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.
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.