Regeneron cGMP Mobile Gowning Cleanroom
Press Release from Germfree Laboratories Inc
Mobile gowning cleanroom, built to meet ISO 7 requirements
Regeneron Pharmaceuticals turned to Germfree's team of experts for a mobile cGMP 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 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,
