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CLEANROOM CONSULTING
Get it right the FIRST time!!!
Cleanroom Consulting, LLC, specializes in cleanroom design and applications, cGMP cleanroom compliance, contamination control consultation, cleanroom and contamination control audits, and 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, manufacturers of Class II and Class III medical devices and for cGMP injection molders.
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Cleanroom Consulting, LLC, specializes in:
- Contamination Control and cGMP Audits
- New Cleanroom Product Introductions
- Project Planning & Basis of Design
- Cleanroom Conceptual Designs
- Cleanroom Applications Engineering
- Process Isolation & Mini-Environments
- Cleanroom Troubleshooting and corrective actions
- Construction Claims Arbitration
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We offer hands-on industry experience -
Contact us for an initial assessment today!
Read the latest article on BioPharmaceutical Facility Design!
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Experience includes FDA validatable multi-user/multi-product microbial & cell culture facilities, cell & gene therapy facilities, aseptic filling, clean containment & implantable devices.
Request a copy of our Cleanroom Planner!
E-mail: info @ cleanroom-consulting.com
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