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503B Outsourcing

Your 503B Outsourcing Facility

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

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

Sterile drug compounding involves preparing customized medical formulations to address individual patient needs. We know that your 503B outsourcing facility faces key challenges including guaranteeing medication safety and efficacy, adhering to FDA regulations, and managing suitable environmental conditions. Improper compounding can be hazardous, making compliance with standards like USP <797> and <800> vital. 503B providers must follow FDA regulations, including cGMPs, for outsourcing facilities.

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

Discover our adaptable, USP <797>/<800> compliant Mobile Compounding Pharmacy trailer, designed to address urgent capacity increases or provide temporary solutions during pharmacy renovations. These all-in-one facilities seamlessly serve individual hospitals or entire systems, functioning as swing space or additional capacity support.

Rely on Germfree to ensure an ideal aseptic compounding environment for handling hazardous and non-hazardous materials, delivering a swift, cost-effective pathway to a smooth, tailored pharmacy operation. Additionally, benefit from our exceptional service support, ensuring uninterrupted performance and customer satisfaction.

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 allows hospitals to keep compounding online with a supplemental and often permanent addition to existing operations.

Key applications:
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Modular

Modular Compounding Pharmacies

Introducing our state-of-the-art Modular Compounding Pharmacy cleanroom facility, expertly designed to accommodate a wide range of pharmacy needs. This customizable solution caters to the long term capacity needs of individual hospitals or entire systems, providing the flexibility and efficiency necessary for today’s demanding healthcare environments.

Trust in Germfree to maintain the highest standards in aseptic compounding, ensuring a safe workspace for handling hazardous and non-hazardous materials. With our exceptional service support, experience a seamless, cost-effective approach to creating the optimal pharmacy operation tailored to your requirements.

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:
View product detail
Interior view of a modular cleanroom
Equipment

Equipment for Compounding Operations

A standard and custom equipment line that was the inception of our company 60+ years ago. Continually innovating this equipment has created a leading edge line of primary engineering controls (PEC)’s that boast 100% stainless steel construction, delicate user ergonomics, and hazardous/non-hazardous capabilities. All of Germfree equipment has a decades long service life across our: 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
  • Best-in-class for cleanability and durability

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Stainless steel casework in a lab

100% Stainless Steel Casework

Germfree's stainless steel casework is a premium choice for laboratory and cleanroom facilities that demand high standards of cleanliness and durability.
Stainless steel casework in a lab

Stainless Steel Laboratory Furniture

Germfree's stainless steel casework is a premium choice for laboratory and cleanroom facilities that demand high standards of cleanliness and durability.
Person working at a biosafety cabinet

Vertical Laminar Flow Hood

The BVBI series is Germfree’s advanced line of Vertical Laminar Flow Hoods.

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

Contact us

Looking for something custom?

We have deployed research facilities for shipment by military aircraft, designed equipment to contain the most dangerous agents on the planet, produced facilities to manufacture lifesaving medicines and mobilized hospital compounding during times of regulatory change. Connect with Germfree experts to unlock your scientific potential.

Contact us: Let's unlock your scientific potential together

Complete our contact form and a member of our commercial team will reach out to you within 24 hours.

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Service & support: cs@germfree.com