cold chain safety

How to Ensure Cold Chain Product Safety

cold chain safetyBy David Parker The vaccine cold chain has one overarching purpose: to maintain product quality from the time of manufacture to the point of delivery to the end consumer. To maintain viability, cold products such as vaccines must be stored and transported within recommended temperature ranges, and this can be a challenge. According to the IQVIA Institute for Human Data Science, the biopharma industry loses $35 billion each year due to temperature-control failures across their supply chains.  The World Health Organization categorizes these failures as follows:
  • 25% of vaccines reach their final destination degraded due to incorrect shipping
  • 20% of temperature-sensitive products are damaged during transport due to broken cold chains. (In a recent Cloudleaf survey, 23% of respondents claimed to lose anywhere from $1 million - $50 million annually in medical inventory spoilage due to cold chain failures.)
  • 5% of pharmaceutical sales are marked as scrap
  • 30% of scrapped pharmaceuticals attributed to logistics issues alone
  • The average costs of root cause analysis for each excursion can range from $3,000 to $10,000
  • The average pharmaceutical organization spends only 6% of its revenue on logistics
Primary Cold Chain Challenges Ensuring an effective distribution process for cold chain products such as the COVID-19 vaccine requires:
  1. Proper product storage and packaging insulation to avoid temperature excursions
  2. Seamless cold chain transit 
  3. Accurate shipping
  4. Reliable storage solutions at the point of care
  5. The ability to deal with unexpected delays, such as severe weather
  6. Detailed documentation so that drivers, shippers and logistics companies can collaborate
  7. High regulatory compliance rates
To accomplish all of the above, two main challenges need to be addressed: lack of visibility into the cold chain, and temperature excursions. Examples of supply chain visibility gaps include no live monitoring through a manufacturing facility, lack of tracking as product flows inside a distribution center, or passive or no product condition tracking at the pallet level as products move and are in-transit. The lack of visibility into an organization’s supply chain can lead to inaccurate predictions, poor planning, delayed decision making, higher risks and loss of business. Vaccines, in particular, require careful temperature control from creation to administration to remain effective. A vaccine’s cold chain begins with the cold storage unit at the manufacturing plant and ends at vaccine administration. Every step of handling and storage must be carefully temperature controlled.  In terms of the COVID-19 vaccine, Pfizer, Moderna and AstraZeneca vaccines have different storage requirements in terms of temperature because of the ways they're structured. The Pfizer vaccine has to be kept at a frigid -70 °C, while the AstraZeneca and Moderna vaccines can be stored slightly warmer. One of the challenges with transporting COVID-19 vaccines is that temperatures may fluctuate inside a trailer, damaging the pharmaceuticals. Another avenue where temperature excursions can occur is when pharma products are loaded/unloaded onto transport. Solving Cold Chain Challenges with End-to-End Visibility The solution to these problems lies in giving businesses real-time data access to their goods, both in the warehouse and in transit. According to an IBM global C-suite study, 84% of chief supply chain officers stated that lack of visibility across the supply chain was the biggest challenge they face. Frank Jones, a recognized global leader in supply chain, agrees that supply chain visibility is crucial. “Visibility... allows you to predict and make rapid changes based on changes that are happening in your product flow. In times where the market change drives different needs, it allows you to have quick responses from your previous plan. You’re always running to a plan,” states Jones. This is especially true for cold chain companies. Since temperature, humidity, light and vibration excursions can happen anywhere along the supply chain, pharma companies would greatly benefit from end-to-end visibility. Higher visibility leads to better decision making that makes operations more efficient, resulting in higher profitability. With end-to-end visibility, companies can capture product-level data, not just information about the truck or container the product is on, which is an incomplete picture. Having visibility into factors around the condition, timing and location of your cold chain products help create a real-time view into what’s happening at every point along the supply chain. Fortunately, there are innovative solutions on the market that can optimize and streamline cold chain logistics. A digital visibility platform like Cloudleaf provides complete visibility into the location of perishable products and responds in real time by providing alerts about location and temperature excursions. The Cloudleaf cold chain solution provides continuous visibility into material loss/damage, real-time location tracking and condition monitoring (temperature, light, humidity, tilt and vibration). Cloudleaf’s predictive capabilities, product tracking and alerts enable preventive action and the safe delivery of medicine and critical supplies. Sensors can potentially be placed on every asset within a supply chain, creating visibility and providing insights that can significantly reduce temperature excursions and other inefficiencies. Cloudleaf takes that product-level knowledge and integrates it with other contextual data, bringing formerly siloed information together for a real-time view of what’s happening on the ground as pharmaceutical goods move along their journey through the supply chain. By addressing gaps in cold chain visibility, pharmaceutical companies gain more control of their supply chain and can mitigate issues before they cause significant loss. The transformational shift from reactive problem solving to anticipating and preventing cold chain issues will drive value across an organization’s entire supply chain.