longer-term projects or by healthcare systems with
Germfree has developed a specific set of quality control and decontamination procedures that are implemented between each new deployment. The unit is
also tested and qualified by a third-party certification professional, typically accredited by the CETA
National Board of Testing, prior to use at a new site.
CE: What does the future hold for this technology?
JS: Hospital and healthcare facilities will continue
to find applications where the MPT can fill a gap in
cleanroom capacity. Practitioners, process engineers
and researchers are now able to see that a viable,
advanced cleanroom space can be built into a mobile
platform. This creates the next-level in rapid deployment and flexibility.
In other sectors, we currently provide similar units
used by pharmaceutical manufacturing
companies for applications ranging from
production of FDA-approved drugs
for human use, manufacturing drugs
for clinical trials as well as training and
evaluation of personnel that operate
within these critical environments. As
the industry transitions toward emerging
biopharmaceutical therapies and small-batch personalized medicine, Germfree’s
Mobile BioPharmaceutical Cleanroom
Trailers will provide a flexible bioproduc-tion platform. This will help companies
dramatically reduce the time to gain
regulatory approval for innovative new
Germfree has been providing equipment
for compounding sterile IV and hazardous
drug preparations to the hospital pharmacy
industry since the early 1970’s. Germfree’s
HEPA filtered, unidirectional airflow
equipment, also called Primary Engineering
Controls (PEC), provide an aseptic environment that allows the pharmacist to handle
sterile products in a contamination-free
environment. As regulations in the hospital
pharmacy have evolved, a shift toward placing PECs into ISO 7 Cleanrooms (Secondary
Engineering Control (SEC) has occurred.
‘Guidelines for Pharmaceutical Compounding – Sterile
Preparations’ (USP 797) and ‘Hazardous Drugs –
Handling in a Healthcare Setting’ (USP 800) define the
requirements for these SECs and PECs.