Purolite, one of the world’s leading manufacturers of ion-exchange resins, has announced that a new, 96 m3, state-of the art clean room is now operational at its manufacturing facility in Romania.
The clean room is equipped for pharmaceutical applications and conforms to all required specifications for Class D microbial limits within cGMP guidelines. It also meets local environmental, safety and health requirements.
This facility is specifically designed for production of Purolite’s APIs, excipients and other specialty resin technologies used in Pharmaceutical and Life Sciences product development and manufacturing.
Product transfer and handling within the clean room is fully automated, and will require minimal human intervention in the manufacturing process. Operations undertaken within the MiniClean room include wet screening, in-column purification and vacuum drying, utilising state-of-the-art automated equipment. The facility also includes a designated changing room and packaging area.
“We are very excited to have this new facility available for Life Sciences, Pharmaceutical and specialty products,” notes Arvind Verulkar of Purolite’s cGMP Romanian facility. “This facility will enable us to respond very quickly to customer requests, and even further enhance our quality control processes.”
Purolite Romania now has a total of four clean rooms in operation.