Class 7 cleanroom used to support product manufacturing for biopharm industry
ILC Dover, the designer and manufacturer of NASA's space suits and a wide range of engineered film and fabric products, has received certification for its ISO Class 7 cleanroom.
Testing of the cleanroom was performed in accordance with ISO Standard 14644 and IEST RP-CC006.3. This facility will enhance ILC Dover's ability to support the global pharmaceutical industry with disposable systems engineered to contain powder transfers from cGMP to nanogram levels.
‘The ISO Class 7 cleanroom will allow us to expand our powder transfer offerings and better serve our biopharm customers,’ said Chris Rombach, Biopharm Products Manager for ILC Dover. ‘ILC has a long history of supporting the powder containment and handling needs of the pharmaceutical industry and this added capability will further enhance our ability to deliver customer focused, cost effective solutions to the biopharmaceutical market.’
The first product line to be produced in the newly certified cleanroom is the EZ BioPac – a powder transfer system to support media and buffer preparation.
Made from ArmorFlex, the EZ BioPac is proven to reduce contamination that typically occurs during filling a powder transfer bag or, more importantly, when it is discharged to the reactor or mix tank.