The unit – to be showcased at Interphex in New York next week – is a 16 meter stand-alone cGMP facility offering ISO grades and biological safety levels up to BSL-3 which spokesman Craig Landy told us is designed to “help manufactures fill the gaps in their processing needs with a rapid deployment model.”
He continued: “The rapid deployment of the Germfree mobile platform reduces the time required for manufacturing start-up significantly over traditional brick and mortar facilities. This complements the need for rapid drug development which ultimately reduces cost.”
Such cleanrooms are ideal for “manufacturers whose processes are small scale, require flexibility, require single process segregation from an existing facility or have facilities under renovation,” Landy added.
“The units can be relocated and expanded when manufacturing needs increase in scale or contract, which is a common industry challenge during pharmaceutical development. [Furthermore] the platform complements disposable technologies that replace or diminish significant utility needs required for production equipment cleaning and water systems.”
While there are no specific rules for mobile production facilities, Landy told us the trailers can fully comply with the regulations for brick and mortar facilities.
“All materials used for construction are pharmaceutical grade and all surfaces including walls, ceilings, doors and workstations are designed for traditional cleanroom cleaning agents including vapor hydrogen peroxide (VHP).”
However, while Germfree works with its clients to ensure processing, material transfer and personnel workflow requirements and regulations are met, Landy said: “Manufactures may need to update regulatory establishment applications or the content of CMC sections of regulatory applications where process changes or critical process equipment are integrated.”