Experience includes: FDA validatable multi-user/multi-product microbial & cell culture facilities, cell & gene therapy facilities, aseptic filling, clean containment, Class II & Class III medical devices, injection molding, nano-bio cleanrooms and aerospace and optical assembly, integration and test.
Cleanroom Consulting, LLC, specializes in cleanroom design and applications, requirements setting, cGMP cleanroom compliance, contamination control consultation and troubleshooting including Foreign Object Elimination and facilities FMEA's, as well as new cleanroom product introductions.
Recently, Cleanroom Consulting has engaged in project planning and basis of design preparation for a new cell therapy technology, as well as for a large cGMP bulk clinicals cleanroom facility and a leading-edge nano-bio cleanroom, performed a “make vs. buy” analysis comparing construction of a new biologics facility to feasible alternatives such as outsourcing/contract manufacturing, provided aseptic cleanroom design support to a leading A&E firm, worked closely with a noted bioprocess consultant for a university gene therapy facility, advised a biotechnology client on the retrofit and validation of a new aseptic fill suite, delivered early-stage product launch consultation for a new enabling biophotonics technology and served as “expert witness” in cleanroom construction and related products litigation.
Cleanroom Consulting is also providing pre-market studies for companies interested in entering into the cleanroom industry. Cleanroom Consulting is advising companies on acquisition, roll-up, marketing and public relations strategies within the cleanroom industry, providing assessment and valuation opinions for existing cleanroom facilities, and developing environmental assessment audits and contamination control (cleanroom compatibility) roadmaps for wafer fab tool builders, optics and laser device manufacturers, manufacturers of Class II and Class III medical devices, nano-fabrication, web processing, automotive components suppliers, high yield thermal vacuum applications, advanced sensor hardware, CMOS imagers and for cGMP injection molding.