Cold chain experts launch
Modality Solutions LLC
Jan 26, 2012 10:40 AM
Five cold chain subject-matter experts have partnered to launch Modality Solutions LLC. Paul J Harber, Gary M Hutchinson, Daniel J Littlefield, Brian Wallin, and Donald Wilson identified a demand for expertise in highly regulated industries, such as the biopharmaceutical, health, nutrition, and wellness business sectors.
This privately held company delivers integrated cold chain management systems that define, minimize, or possibly eliminate transportation environmental hazards in the supply chain. Modality Solutions provides engineering/logistics consulting, systems integration, and simulation laboratory services from discovery through distribution.
The firm is positioned to:
•Ensure regulatory compliance in highly regulated industries.
•Deliver cold chain management/thermal packaging design/qualification and controlled-environment logistics systems.
•Conduct transport simulation testing with five environmental hazards: temperature, humidity, shock, vibration, and pressure.
•Decrease development cycle times for a faster route-to-market.
•Develop transport validation strategies to support global regulatory applications.
Harber is a founding member of the Parenteral Drug Association (PDA)/Pharmaceutical Cold Chain Interest Group (PCCIG). He co-wrote the PDA Journal of Pharmaceutical Science and Technology Technical Report Number 39 (PDA TR#39).
Hutchinson, former director of global transportation at Amgen, has designed logistics networks and systems for biologics and solid oral dosages—including cold chain logistics networks, import/export compliance, and transport validation.
Littlefield is an expert in process improvement, safety, and security with experience in a variety of industries. During his tenure at DuPont, he was assigned as a Six Sigma Black Belt, Six Sigma Master Black Belt (MBB) and an expert LEAN Practitioner.
Wallin co-wrote with ISTA the first global standards of insulated shipping container performance (Standard 7E) and testing methodology and lab certification (Standard 20).
Wilson designed, tested, and implemented a nitrogen overlay process, automated vial washing systems, needle-free syringe technologies, and container closure integrity testing.
In addition, Rafik H Bishara serves as a technical advisor to Modality Solutions. He is the chairman of the PDA/PCCIG.
To learn more, visit www.modality-solutions.com.
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