Innovative Solutions... Delivered

Thermal Package Design and Testing

PHASE I - Needs Assessment

We communicate our capabilities, and assess your situation using a detailed needs assessment form. We collect information on your payload, container, shipping method, and acceptable temperature ranges and excursions. When necessary, we can assist you in evaluating and/or compiling ambient temperature profiles. Based on your requirements, we prepare a detailed budget estimate for your approval.

PHASE II - Thermal Solutions

Design- Using our extensive knowledge of thermodynamics, software modeling programs, and our proprietary database of successful designs, we develop optimal thermal solutions for your temperature- or thermo-sensitive products. We analyze your total cold chain requirements - distribution, logistics and economics.

• We consider overall costs, and the cost-effectiveness of the insulating material (based on its R-value), refrigerants, ease of pack-out, overall size and weight of system, materials of construction, and type of shipment.
• We use our testing chambers to refine and improve our designs. By thermally mapping your prototype's payload area, our cold chain equipment will identify high and low temperature points. If necessary, we alter the prototypes and quickly converge on an optimized design.
• To build full-scale prototypes, we access the vast manufacturing resources of our affiliated company, Cold Chain Technologies. It has a long and successful history of producing a complete array of packaging products. Its product line now includes Koolit® refrigerants, KoolTemp™ insulated containers, and KoolWatch™ electronic temperature indicators.

Pre-Qualification Testing- Using the final prototype or your packaging system, we conduct a pre-qualification cold chain assessment test in our environmental chambers. Our data acquisition units, the GE Kaye Validator 2000, generate test results that trace to NIST standards within ±0.3°C. This critically exacting system is the core of our test's accuracy and reliability. A successful pre-qualification test assures us that the package design will pass the Phase III Final Qualification. Upon completion, we provide you with a pre-qualification testing report (hard copy and CD) containing:

• a graphical summary of results,
• detailed 3D diagrams that display pack-out components,
• thermocouple locations, and
• critical design data, including weights, dimensions, components used, and conditioning.

PHASE III - Final Qualification/Validation

The Final Qualification, also called validation, is a detailed study, often done in triplicate (n=3), that demonstrates the reproducibility of Phase II Pre-Qualification Testing. Final Qualification results may be used to comply with internal and external audits. The strict protocol - written by us or jointly with you, and signed by both parties - documents all aspects of the study. We conduct extensive advance preparations, and follow exacting standards to cGMP guidelines.

Upon completion, you will receive a formal report (hard copy and CD) that contains 3D drawings of your package, a bill of materials needed for your efficient cold chain solution, summaries and written explanations, and clearly labeled graphs and tables of certification and Kaye DAU data. The report includes:

• testing details and conditions
• acceptance criteria
• thermocouple probe positioning
• data and graphical analyses
• schematic diagrams
• written description of test results
• photographs
• non-conformance, if applicable
• relevant SOPs
• certification documentation

PHASE IV - Customer Support

Our commitment to you goes beyond the final report. Arrangements can be made for follow-up support by email, phone, or at your site. We're available to:

• review and interpret your data and findings,
• develop internal operational SOPs,
• coordinate procurement and scheduling of materials,
• interpret ISTA requirements and ASTM, FDA, USDA, and HACCP guidelines,
• update you on our new products and research and development, and
• provide you with on-going support with your cold chain distribution.