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503B Outsourcing

Application

Your 503B Outsourcing Facility

Pioneering safe, large-scale compounded medications for advanced healthcare needs

Pharmacist in LFGI

Germfree understands the unique challenges associated with 503B sterile drug compounding

Running a 503B outsourcing facility means compounding sterile drugs at scale, safely, and under FDA scrutiny, all at once. Get any piece of that wrong, efficacy, environmental control, USP <797>/<800> compliance, and the risk isn’t just a failed audit, it’s a hazard to the patient at the other end. Every outsourcing facility answers to FDA cGMP requirements, and the facility itself has to be built to make meeting them the default, not the exception.

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503B Outsourcing Facility and Equipment Solutions to Meet Your Needs

Select from a variety of facility options and equipment. If these do not meet your needs, reach out and learn more about our custom solutions.

Mobile

Mobile Compounding Pharmacies

Germfree’s Mobile Compounding Pharmacy is a USP <797>/<800> compliant trailer built to solve a capacity problem fast, an urgent increase in volume, or a pharmacy renovation that can’t take the whole operation offline. It functions as swing space for a single hospital or an entire health system, backed by the same service support behind every Germfree platform, so the aseptic compounding environment stays exactly what it needs to be for as long as it’s running.

Learn more about our mobile facilities
  • Germfree has deployed more than 100 mobile pharmacy cleanroom facilities globally since 2015
  • Compliant to USP<797>/<800> , CETA CAG-003-2006, ISO Class 7/8 Rooms
  • Rapid deployment, minimizing downtime
  • Biosafety Cabinets, Laminar Flow Hoods, Storage, Gowning Benches, and 100% Stainless Steel Casework can be included
  • 24/7 hour service support and maintenance for optimal cleanroom performance
  • Available for sale or lease

Mobile Compounding Pharmacies

Germfree’s Mobile USP 797/800 Compounding Pharmacy keeps compounding online as a supplemental, often permanent, addition to existing operations.

Key applications:
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Modular

Modular Compounding Pharmacies

Germfree’s Modular Compounding Pharmacy is a prefabricated cleanroom platform built for the long-term capacity needs of a single hospital or an entire health system, with the layout flexibility to fit the workflow rather than the other way around. It handles hazardous and non-hazardous materials in the same aseptic compounding environment, backed by the same service support that keeps every Germfree platform running at spec.

Learn more about our modular facilities
  • Compliant to cGMP, USP<797>/<800> , CETA CAG-003-2006, ISO 14644
  • Designed for particulate control with compliance to cGMPs and ISO 14644 room classifications ISO 5, 7&8
  • Rapid deployment, minimizing downtime
  • Versatile layout options, optimizing workflows
  • High-quality construction reduces the potential for contamination
  • Integrated Biosafety Cabinets, Laminar Flow Hoods, Storage, Gowning Benches, and 100% Stainless Steel Casework
  • 24/7 hour service support and maintenance for optimal equipment performance

Modular Compounding Pharmacies

Germfree’s Modular Compounding Pharmacy is a USP <797>/<800> compliant, non-hazardous and hazardous drug compounding facility inside our modular platform.

Key applications:
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Interior view of a modular cleanroom
Equipment

Equipment for Compounding Operations

Germfree built its first piece of equipment more than 60 years ago, and six decades of continuous refinement built the PEC line we make today: 100% stainless steel construction, ergonomics designed around daily use, and the flexibility to handle both hazardous and non-hazardous materials. That refinement shows up as a decades-long service life across Laminar Flow Workstations, Biological Safety Cabinets (BSC), Compounding Aseptic Isolators (CAI), Compounding Aseptic Containment Isolators (CACI), Powder Hoods, and Material Pass-Throughs.

Learn more about our equipment
  • Standard Biosafety Cabinets and Laminar Flow Hoods ship fast
  • Restrictive access barrier and pharmaceutical isolator technology available
  • NSF/ANSI49 options available
  • 24/7 hour service support and maintenance for optimal equipment performance
  • 304L and 316L stainless steel construction
  • Durable and easy to clean, backed by a service life spanning decades
Smarthoodâ„¢

Smarthoodâ„¢

Smarthoodâ„¢ is our innovative solution that integrates essential peripherals like touchscreen PCs, cameras, scales, and printers directly into a clean, clutter-free hood, enhancing aseptic technique and streamlining your workflow.
Stainless steel casework in a lab
Stainless Steel Laboratory Furniture

Stainless Steel Laboratory Furniture

Germfree's 100% stainless steel laboratory furniture resists corrosion, rust, and bacterial growth, custom designed for your lab or cleanroom.
Person working at a biosafety cabinet
Vertical Laminar Flow Hood

Vertical Laminar Flow Hood

Germfree's USP 797-compliant Vertical Laminar Flow Hood filters 99.99% of particulates at 0.3 micron, in a 100% stainless steel, sterile workstation.

Frequently Asked Questions

What is a 503B outsourcing facility?

A 503B outsourcing facility is an FDA-registered site that compounds sterile drugs at scale under cGMP regulations, rather than one-at-a-time for an individual patient. 503B facilities must follow FDA cGMP requirements, unlike 503A compounding pharmacies, which operate under different regulatory standards.

What’s the difference between a mobile and a modular compounding pharmacy?

A Mobile Compounding Pharmacy is a trailer-based, USP <797>/<800> compliant facility built for urgent capacity increases or as temporary swing space during pharmacy renovations. A Modular Compounding Pharmacy is a prefabricated cleanroom facility designed for longer-term capacity needs across an individual hospital or an entire health system.

What compliance standards do Germfree’s compounding facilities meet?

Germfree’s mobile and modular compounding pharmacies are built to USP <797>/<800>, CETA CAG-003-2006, and applicable cGMP and ISO cleanroom classification standards (ISO 5, 7, and 8 rooms, depending on configuration).

What applications do Germfree’s 503B outsourcing solutions support?

Germfree’s mobile and modular compounding platforms support 503B Outsourcing, Hospital Compounding, Radiopharmaceuticals, and Hazardous Drugs applications.

What equipment is used in Germfree’s compounding facilities?

Compounding operations are supported by Germfree’s primary engineering controls (PECs), including Biosafety Cabinets, Laminar Flow Hoods, Compounding Aseptic Isolators (CAI), Compounding Aseptic Containment Isolators (CACI), Powder Hoods, and Material Pass-Throughs, built with 304L/316L stainless steel construction.

Can Germfree’s compounding facilities handle both hazardous and non-hazardous drugs?

Yes. Germfree’s mobile and modular compounding pharmacies are designed to handle both hazardous and non-hazardous materials within the same aseptic compounding environment.

Talk to us about your 503B outsourcing facility or equipment needs

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When your mission calls for something custom, we deliver.

Some environments can’t take a catalog answer: the one-of-a-kind containment lab, the facility that has to survive shipment by military aircraft, the compounding pharmacy that has to stand up overnight. Tell us the constraints, we’ll build around them.

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