Steve Winyard

Portfolio Strategies – Life Sciences
Inmark


3:15 PM Controlled Room Temperature (CRT) Transportation: Packaging, Reverse Logistics, Validation and Risk Assessments

The storage and distribution of controlled room temperature (CRT) life science products is a costly and complex process, and requires attention at every level from packaging to logistics, monitoring to data. As we enter an age of biologically based medicines, the need to monitor and control temperature sensitivity is increasing. Regulators are also putting more focus on how CRT products are being shipped and transported. Alongside this, increasing scrutiny from the regulators is driving manufacturers to invest in CRT solutions and acquire the right talent to ensure quality and compliance. The industry must monitor and gain access to real-time data while CRT products are in transit, increase in the use of data loggers, devices and sensing technology shows the industry is moving towards more monitoring. The goals of our workshop is to discuss the trends, issues and successes operating within the CRT arena

What you will learn:
  • Strategies to decide between reusable vs single-use containers for CRT transportation
  • How to assess durability & temperature stability
  • Ways to calculate the price tag attached to reverse logistics
  • Different approaches to validation and risk assessments