Filling in the Engineering Gap
One of the most common mistakes in preparing products for the cold chain is using the wrong shipping profile, reports Gary M. Hutchinson, formerly director of global transportation at Amgen. “As a result, companies could be over designing or under designing their packaging systems.” Such a mistake means that companies could be spending far too much on their systems—or protecting their products far too little.
“At Amgen, I had a fantastic team as I managed packaging design, carrier operations, import/export compliance, and quality management system, and more,” he says. “But many mid-tier and start-up companies do not have this expertise on staff.”
|Gary M. Hutchinson|
Hutchinson along with four other cold-chain experts are now setting out to help these companies fill that gap. Modality Solutions LLC will provide engineering/logistics consulting, systems integration, and simulation laboratory services from discovery through distribution. The subject-matter experts include Hutchinson, Paul J. Harber, Daniel J. Littlefield, Brian Wallin, and Donald Wilson. Rafik H. Bishara Ph.D. serves as a technical advisor to Modality Solutions; he is the current Chair of the Pharmaceutical Cold Chain Interest Group (PCCIG), Parenteral Drug Association (PDA).
“We have well over 100 years’ experience between us,” says Hutchinson.
Many of these experts have played a leadership role in several industry-recognized associations (PDA and IQPC) and standards-based organizations (ISTA and ISPE), helping produce a number of guidance documents. But the industry is “light on standards in terms of methodology and testing,” Hutchinson says. “We can help by filling in the engineering, ‘how-to’ role, by devising SOPs and writing protocols and reports to support validation.”
Specific services include:
• Ensure regulatory compliance in highly regulated industries.
• Deliver cold chain management / thermal packaging design / qualification and controlled-environment logistics solutions.
• 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.
Along with its partner company Bioconvergence (Bloomington, IN), Modality Solutions is also making plans to design, calibrate, and validate a GMP-compliant lab. “We plan to run ISTA profiles and offer shock, vibration, and temperature testing,” says Hutchinson. “We also plan to simulate the belly of an airplane, the bed of a truck, and the deck of a ship.”
The company is currently developing its quality system approach to cold-chain management. “Many FDA and PDA guidances put forth a robust approach to maintaining quality in an effective manner,” he says. “We plan to support this approach with our validation and engineering expertise.”
Modality Solutions will be working with pharmaceutical manufacturers as well as suppliers of insulated shippers, data loggers, and larger active systems.
When asked why using a consultancy would be needed when many suppliers offer similar support, Hutchinson explained that “an integrated approach like ours is needed. Vendors support the design, engineering, and validation of their own technology. But a drug manufacturer/packager has many more specific needs, like managing carriers as well as packaging and quality management system support. These manufacturers also have to ask themselves this question when being presented a shipper supplier’s profile: Is it valid for their lanes?”
Using an integrated cold-chain approach “saves time and leads to a more-robust, defendable process,” he adds. “There is strength in having such end-to-end visibility. We write into our contracts performance to specific deliverables. We get paid to deliver results, rather than billing for time and materials.”
The company founders bring extensive industry experience. Harber is a founding member of the PDA Pharmaceutical Cold Chain Interest Group (PCCIG). He also coauthored the PDA Journal of Pharmaceutical Science and Technology Technical Report No. 39 (PDA TR#39) and is the 2008 recipient of the Eli Lilly Engineering Excellence Award.
Hutchinson, in addition to his work for Amgen, has been a member of the PDA PCCIG and frequent speaker at PDA events.
Littlefield is an expert in process improvement, safety, and security with experience in a wide variety of industries. While working for DuPont, he was assigned as a Six Sigma Black Belt, Six Sigma Master Black Belt (MBB) and an expert LEAN Practitioner. Littlefield is a two-time recipient of DuPont’s Engineering Excellence Award.
Wallin co-authored with ISTA the first global standards of insulated shipping container performance (Standard 7E) and testing methodology and lab certification (Standard 20). Wallin received Amgen’s Excellence in Science and Engineering Award for his work in shipper development.
Wilson focuses on primary packaging, having designed, tested, and implemented a nitrogen overlay process, automated vial washing systems, and needle-free syringe technologies. Wilson received Amgen’s Excellence in Science and Engineering Award for his work in shipper development.
To learn more about Modality Solutions visit http://www.modality-solutions.com.