Modular USP 797 & 800 Compliant Facilities Installed on your Site
The Fast and Reliable Solution for New Compounding Capacity
We offer a comprehensive range of cleanroom facilities for sterile and hazardous drug operations. Configurations are available for integration with existing buildings, free-standing pharmacies and full 503B compounding centers. Our single-source solution provides a complete pharmacy with all standard equipment. Germfree handles all aspects of your new cleanroom — delivered and made operational in a truncated timeline.
Wide Variety of Configurations and Sizes Available ⎯ from Free-standing Compounding Facilities to Modules Integrated with your Existing Building
Germfree Modular allows you seamlessly add capabilities and capacity while maintaining your current operations. This averts site disruptions and unpredictable variables common to renovations and brick and mortar construction.
We are a recognized leader in the manufacture of pharmacy equipment and our advanced engineering and leading edge modular fabrication technology allows us to provide a fully compliant pharmacy cleanroom. Our transportable pharmacies meet the rigorous standards for USP 797/800 compliance and are deployed across all regions of the US. This combined experience allows Germfree to offer this unique solution for immediately adding compounding capacity.
Distinct Work Zones for Sterile and Hazardous Drug Compounding
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, which are vented to the outside, to protect the product and personnel while preparing hazardous drugs.
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.
ISO Class 7 / 8 Anterooms: These rooms serve as antechambers and as changing areas for personnel to don their Personal Protective Equipment (PPE).
Additional Spaces May Include: Negative pressure storage areas for hazardous drugs, supply storage, restrooms, break rooms, and other areas as necessary to create a complete facility.
Reduced Timeline: Our project timelines are unaffected by inclement weather or unforeseen construction issues. Additionally, site work can be completed simultaneously with modular facility manufacturing, substantially reducing time to occupancy.
Reduced Risk: Germfree Modular facilities are engineered and manufactured at our modern production facility by our experienced team. All work is completed in a controlled factory environment where each modular facility is assembled to a fully operational state and subjected to a Factory Acceptance Test (FAT). The FAT process guarantees the full functionality of complex mechanical/HVAC components prior to delivery and mitigates the risk of onsite complications.
Reduced Cost: Traditional cost estimates often tail to include many “soft costs” associated with traditional building construction. That is why architecture, engineering and equipment integration are all included in our pricing. More importantly, Germfree Modular eliminates the cost associated with having an active construction site interfering with your operations. By shortening the timeline, allowing for faster occupancy and reducing the risk inherent to any traditional building or renovation endeavor, Germfree Modular provides many advantages over conventional methods.
Facility Compliance for USP 800
USP 800 introduces new standards for handling hazardous drugs, adding to USP 797 sterile compounding guidelines. The chapter describes comprehensive changes to infrastructure and engineering controls. The most significant challenges are centered on build-outs for separate positive and negative pressure buffer areas.
USP 800 Venting Requirements
Consistent and reliable cleanroom functionality demands superior construction and advanced engineering controls. Negative pressure buffer rooms for hazardous drugs must be exhausted to the outdoors. External venting adds a layer of complexity to maintaining a properly balanced cleanroom under dynamic conditions.
Germfree’s Modular Pharmacies resolve many challenges of a USP 800 build-out: