On-site, On-demand, On-time & In-Control of Your Clinical Trials
Compounding facilities that meet USP 797/800 standards are generally limited to dedicated sites in traditional buildings. Germfree’s mobile units provide a new range of solutions for managing drug trials. Biopharmaceutical companies, CRO’s, CMO’s, and CDMO’s are discovering many advantages to administering trials within close proximity to the clinical investigation sites. This is particularly relevant for dispensing compounded sterile preparations, newer biologicals, and advanced therapy medicinal products (ATMP’s). Germfree’s Mobile Cleanrooms can help you manage biopharmaceutical studies across multiple sites and mitigate logistical challenges.
Germfree’s bioGO® Mobile Cleanrooms Serve a Range of Uses and Applications, Including:
- Compounded Sterile Preparations (CSPs)
- Cell and Gene Therapy
- Cytotoxic preparations and other oncology protocols
- Vaccines and other biologicals
- Unique transdermal therapies that are mixed on-site including neurotoxins
- Drug trials that must be conducted in close proximity to the impacted geographic area
- University-based studies
- Ease of coordination with Key Opinion Leaders (KOL) and clinical investigators
- Phase II studies in multiple countries and remote regions
- Seamless operation during renovations of fixed facilities including hospital pharmacies and CROs
- Germfree’s bioGO® Adaptive Mobile Cleanrooms deliver maximum flexibility for Biopharmaceutical companies, CRO’s, CMO’s, and CDMO’s. Clinical drug trials can be run with complete quality assurance anywhere they are needed. Germfree’s innovative solutions boost overall performance and help accelerate Time-to-Market
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).
Germfree’s Rental Compounding Cleanrooms 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 A2 Biological Safety Cabinets to protect the product and personnel while preparing hazardous drugs. The custom casework, as well as an integrated refrigerator and freezer, provide ample storage space. 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.
The facility includes an entry/office area. The main entrance door is equipped with the proper security for your application.
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.
Connections for shore power are provided. There is also the option to run the unit with an on-board diesel electrical generator.
The plumbing system includes an on-board fresh water tank and an on-demand electric water pump to for the 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.
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 located in the anteroom.
Cameras and Monitors:
Digital video cameras and a digital video recorder (DVR) are provided for perimeter security.
Germfree offers on-site installation supervision as well as training for personnel and maintenance.
Germfree’s Mobile Pharmacies offer maximum flexibility of operations and efficient workflow. Mobile facilities are engineered with enhanced ergonomics for ease of use and maximum user comfort.
Flexibility of Operations: Germfree’s bioGO® Mobile Pharmacies are designed by a team of I.V. pharmacy and cleanroom 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.
Germfree’s Compounding I.V. Pharmacy/Cleanrooms are engineered and equipped for the most efficient workflow. Each mobile 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.
Hoods and workstations and all other fixtures are designed for ease of use and maximum user comfort.
USP 797/USP 800, NIOSH and FDA cGMP Requirements:
Germfree’s turnkey Mobile Pharmacy/Cleanrooms meet or exceed the requirements of the USP General Chapter <797> Pharmaceutical Compounding – Sterile Preparations and USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings. 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 cleanrooms meet the latest requirements with low wall return. The units are engineered for precise HVAC, airflow, air pressure, balance strategies, and proper positioning of all biosafety cabinets and laminar flow hoods.
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.