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.
These systems support cost effective manufacturing every day with applications ranging from single use transfers to multi-use flexible enclosures.
"The ISO Class 7 Clean Room 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 with 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.
About ILC Dover
Since 1947, ILC Dover has provided engineered solutions to complex customer problems, serving the aerospace, personal protection and pharmaceutical industries. Known for production of space suits for NASA, ILC is a world leader in the use of high-performance flexible materials, allowing for unique solutions to meet customer needs. ILC's innovative products have been used on the moon, on Mars and around the globe.
ILC Dover