Cold Chain Management

Maintaining the Quality of Temperature Sensitive

Bio-Pharmaceutical Products using Advanced Simulation Technology

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Product temperatures are dependent upon pack out configurations and specificshipping routes, resulting in an extensive amount of research and thermal test-ing for each combination of shipment conditions. Testing and validation, followingGood Manufacturing Practices (GMP) guidelines, takes a considerable amount oftime, effort and cost, directly impacting the efficiency and cost effectiveness ofcold chain transport systems.

The use of advanced thermal simulation technology can greatly benefit design,development and testing of cold chain distribution packaging. Simulation facili-tates quick and efficient development of digital thermal models using real envi-ronmental conditions. Thermal modeling contributes significantly towards thereduction of time in design cycles and product release.

Thermal validation and certificationof cold chain shippers is of critical importance for the safe and efficient transport of essential pharmaceutical products.

Shipper Temperatures Air Flow Air Temperatures

Advanced Simulation Technology facilitates• Efficient optimization of design

concepts & revisions

• Evaluate alternative distribution routing profiles

• Qualify designs for specific ambienttemperature profiles

• Reduce the need for iterative physical testing

• Assess impact of temperature excursions during shipment

• Meet or exceed industry quality standards

• Reduced product liability costs“ Today we are designing and testing temperature-sensitive transport shippers virtually

with NX. This has made us faster, more flexible and more effective at helping ourpharmaceutical and biotech customers protect their valuable products throughout the transportation cold chain.”Larry Gordon, President, Cold Chain Technologies

www.mayahtt.com

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MAYA’s predictive software technology can be utilized to design any passive or active shippingconfiguration, as well as simulate its transportation over any route. Simulation provides accuratetemperature predictions quickly and efficiently for any packaging system, therefore allowing op-timization of payload configurations. MAYA’s simulation results have been extensively validatedagainst physical test data for a wide range of packaging options. Accurate prediction of any ex-cursions in product temperatures during a transportation cycle can be easily visualized, resultingin a reduction of testing time and costs.

Complex physics inherent in cold chain shipper design canbe modeled precisely. Transient phenomenons, such asphase change, which have a direct impact on product tem-peratures, are predicted accurately. Powerful 3D flow tech-nology is automatically coupled with thermal simulationto model buoyancy driven flow in shipper air gaps. Envi-ronmental heating effects, such as solar heating, can bemodeled accurately at any global location. Humidity distri-bution and Condensation on surfaces can be calculatedbased on local thermal and flow conditions.

MAYA also provides structural analysis tools used to modelstatic and dynamic response of shippers and packagingsystems. Structural simulation software can be used to ac-curately simulate ISTA standards such as Drop/Impact andRandom Vibration Tests.

Typical pack outs can beeasily modeled usingpowerful meshing tech-niques. Componentssuch as Phase ChangeMaterials (PCMs), gelpacks, product packages,etc. can be representedquickly and accurately.

Accurate transientthermal response ofshipper pack outs canbe obtained for anytime interval.

Phase change charac-teristics of PCMs can bemodeled efficiently.Transient response ofPCMs is automaticallycalculated.

Cold Chain Management

Product Temperature vs. Time plots can be obtained for any givenambient profile. Ambient temperature profiles can be customizedto represent any specific product routing.

MAYA HTT LtdCorporate Headquarters4999, St.Catherine St.West, Suite 400Montreal, Quebec, Canada, H3Z 1T3Phone: 800-343-6292 or +1-514-369-5706Fax: 514-369-4200 info@mayahtt.com

MAYA Simulation Technologies Ltd.Regional OfficeDan Mercier Regional ManagerP.O. Box 1505, Westford, MA 01886, USACell: 978.314.6050 Dsk: 978.392.7955 Fax: 978.392.7998dan.mercier@mayahtt.com

Experimental vs. Simulation Results

Maya is a leading

provider of simulation

software and technical

services for digital

product development.

Through the develop-

ment and deployment

of thermal-fluid

software systems, Maya

assists engineering

teams with design

optimization and

improved process

efficiency that ensure

product integrity. As a

development partner

for Siemens PLM

Solutions, a worldwide

leader in Product Life-

cycle Management

products and services,

Maya solutions are

deployed worldwide

across a wide array

of industries.

Cold Chain Technologies is a global provider of thermal packaging solutions to the pharmaceutical, biotech and healthcare industries. With engineering services, products and distribution throughout North America and Europe, CCT's team leads the industry in delivering innovative solutions for the control of temperature-sensitive shipments.

KoolDesigns™, Cold Chain Technologies’ service offering based on MAYA’s Advanced Thermal simulation technology, accomplishes the complex task of predicting thermal performance of its transit package designs by accurately modeling conduction, convection, phase change, and radiation.

Images courtesy of Cold Chain Technologies.