Regulatory Filing Support
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
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.
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.