Skip to main content

Regeneron cGMP Mobile Gowning Cleanroom

Regeneron cGMP Mobile Gowning Cleanroom

Regeneron Pharmaceuticals


Mobile cGMP gowning cleanroom

cGMP sterile fill operator gown certification training

Rensselaer, NY

Mobile gowning cleanroom, built to meet ISO 7 requirements

Regeneron Pharmaceuticals turned to Germfree's team of experts for a mobile cGMP gowning cleanroom that met ISO 7 design parameters and supported gowning training and aseptic qualification.
Project features

Size: 53′ trailer

Layout configurations: Custom

Facilities/Equipment: Class II BSC

Features: ISO 7 Cleanroom with BSC, lockers, case work

The challenge

According to cGMP regulations, all operators working in Grade A or B cleanrooms must be trained and certified in proper gowning procedures. The training should cover the correct techniques for donning and doffing gowns, hoods, gloves, and any other necessary personal protective equipment (PPE). Additionally, the training should cover environmental monitoring requirements, such as air sampling and surface monitoring, and emphasize the importance of maintaining a clean and sterile environment.

Having a dedicated space for gowning training and certification has several benefits, including standardizing the process across all operators, providing a controlled environment for environmental monitoring, and segregating the gowning and certification process from other manufacturing activities.

Germfree was given the opportunity to provide a turnkey mobile gowning cleanroom solution to perform gowning certifications outside of a pharmaceutical production facility.

The answer

Germfree Laboratories, Inc. expertly addressed the technical challenges of creating a mobile cGMP cleanroom. The design integrated unique features such as interlocking doors and a custom, interlocked pass box, thereby meeting ISO 7 parameters and ensuring exceptional cleanliness standards.

The room, designated for gowning training and process technique qualification, was outfitted with a Germfree-manufactured Class II biological safety cabinet (BSC). This cabinet ensures a secure environment for handling sensitive biological materials.

To provide a flexible and efficient cleanroom solution, Germfree designed and installed a mobile cGMP cleanroom on a 53′ tractor trailer chassis, tailoring it to the company’s specific needs.

In June 2016, this mobile cGMP cleanroom was successfully delivered to Regeneron Pharmaceuticals in Rensselaer, NY.

This facility was built on using Germfree’s proven mobile cGMP cleanroom platform, click here to learn more about our cGMP cleanrooms.


Learn more about our proven process and quality for successful projects

Learn more

You might also be interested in

Mobile BSL 2 Walkthrough

Compact and Rapidly Deployable: Germfree’s 24′ Mobile BSL-2 Laboratory

Join our Sales Engineer, Sean Bartholomew, and Mechanical Engineer, Krishna Aravinthan, as they discuss the technologies and advantages of Germfree's compact, rapidly deployable 24' Mobile BSL-2 Laboratory Solution.
Mobile BSL 3 Walkthrough

Mobile BSL-3 Laboratory Walkthrough: An Engineering Perspective

Join our Engineering Lead, Randy Sorrentino, as he takes you on a quick tour of one of Germfree's Mobile BSL-3 Laboratories before it is delivered to the Midwest United States.
Mobile trailer walkthrough

Germfree’s bioGO® Mobile cGMP Cleanroom Product Walkthrough

Jeff Serle, Germfree's COO, reveals the future of mobile biopharma innovation with an in depth product walkthrough. Germfree's bioGO® Mobile cGMP Cleanroom is in its final construction state before a…

Contact us: Let's unlock your scientific potential together

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

White email icon on a green diamond

Service & support: