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:
- Integrated external exhaust system may eliminate the need for retrofit projects, which are sometimes not feasible
- Separate module ensures segregation of hazardous drugs from other buildings
- Germfree’s pre-engineered, tested and proven approach assures all operational requirements are met on day one