Regulatory Filing Support

Transport Simulation

Transplant Simulation Laboratory

Our Advantage Transport Simulation Laboratory™ enables the study of transport stresses on your drug product during the development process. Your product is exposed to not only temperature and humidity hazards, but also pressure, shock, and vibration. Regulatory expectations are driving leading companies to incorporate transport testing into both their development and stability programs.

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5 Testing Hazards

  • Temperature
  • Humidity
  • Pressure
  • Shock
  • Vibration

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Examples of Risks by Category

Biologics and Vaccines

Shock and vibration events, in conjunction with temperature have been shown to generate sub-visible particles and inactivate vaccines.

Diagnostics

Reliable results from diagnostics assume the stability of the indicator and are highly susceptible to damage from multiple hazards in the supply chain.

Solid Oral Formulations

While usually thought of as the most physically stable of all pharmaceutical preparations, uncoated tablets can lose pharmaceutical elegance.

Combination Medical Devices

While a combination medical device are convenience, the transport can threaten the integrity of your device and render it defective.

A Few Of Our Regulatory Filing Support Case Studies

A Few Of Our Regulatory Filing Support Case Studies

Questions?
Schedule your free one-hour, no obligation consult.

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  • Insulated box liner
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  • Molded EPS cooler

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