The Cleanroom Solution
The Germfree Portable Shielded Isolator provides the ultimate in both product and operator protection. The shielded isolator functions as a “glovebox” using negative pressure to meet NIOSH recommendations while complying with USP<797> and <825> regulations for use outside a cleanroom.
HEPA filtered unidirectional (laminar) air bathes the work area to protect the product from contamination and removes any particulate generated by sample manipulation. The operator is provided a complete shielded barrier from materials being manipulated in the work area. The Germfree Shielded Isolator meets or exceeds ISO 14644-1, ISO Class 5 (Class 100) air quality. Each shielded isolator undergoes rigorous physical testing to assure the unit meets performance requirements as validated. It is required that independent certification be performed before use.
What is a Barrier Laminar Flow Isolator?
According to the Food and Drug Administration, a barrier isolator is “a decontaminated unit supplied with HEPA filtered air that provides uncompromised continuous isolation of its interior from the external environment, including surrounding cleanroom air and personnel.”
By installing a certified barrier isolator, one can obtain cleanroom conditions within a contained workspace. Barrier isolators provide an ISO Class 5 (Class 100) environment for product preparation, with work occurring inside a closed, pressurized environment accessible only via sealed gloves that reach into the work area.
A Shielded Glovebox is not a certified barrier isolator. By choosing a certified barrier isolator, the requirement for an ISO Class 8 environment is eliminated. The Germfree Isolator is an excellent example of a well-designed shielded barrier Laminar Flow Isolator, meeting all standards and more.
Current Good Manufacturing Practice--Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act. (2020, January).