Monitoring the chain


A pharmaceutical product in transit may be handled as many as 15 times before final delivery, creating multiple opportunities for mishandling or exposure to conditions beyond the packaging threshold. Multiple cost-effective solutions are available to predict, prevent and detect hidden damage caused by temperature, impact or humidity. Data recorders, electronic monitors and chemical indicators are used to record excursions or to reduce risk exposure.

While a product is in transit, it may be handled as many as 15 times before it is delivered to its final destination

No matter how good the supply chain planning, the unexpected can always happen. Kevin Kohleriter, vice-president of product management and marketing at ShockWatch Corporation, reviews some of the advances in technology used in predicting cold chain incidents.

Between product safety and protection, packaging cost and preservation, it should come as no surprise that pharmaceutical packaging professionals must consider a vast number of design, validation and supervision criteria to maintain product quality. And although multiple products and services are available for evaluation, success in the cold chain comes down to knowing how to deliver a product with temperature controls adapted to shipping and warehousing circumstances; for example:

  • What type of containers and carriers to use
  • What refrigeration or humidity control equipment is required (if any)
  • What environmental conditions are to be expected at each location along the distribution chain
  • The length and time of the distribution route

While it may be well known that transportation and warehousing conditions are essential to the chain of custody, how can a company know when and where an incident has happened? Did a door get left open on a refrigerated truck? At what point during the delivery of the crates to the dock did the product get left outside in 34C temperatures? Who was the carrier at the time of the incident and has this happened before with this carrier?

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