Digital supply chain solutions for visibility, quality, and compliance.
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Cold chain management, Pharmaceuticals
A: Billions of dollars’ worth of temperature-sensitive pharmaceutical products are stored and shipped every year. More types and numbers of drugs are sensitive to temperature than ever due to therapeutic developments and the greater volume of products shipping every year. The term “cold chain” for uninterrupted refrigeration has given way to “temperature-controlled.” The spectrum ranges from ambient, or controlled room temperature (15/20°C to 25°C), to refrigerated (2°C to 8°C), to cryogenic (below 0°C to as low as –150°C).
Generally, the earlier pharmaceuticals are in the supply chain, the greater the control there is, and the less investment is made to ensure proper storage, handling, and distribution. The deeper you go into the supply chain, the less control generally is exhibited and the less investment is made to ensure proper storage, handling, and distribution. The consequences of lack of control and measurements taken to ensure proper storage, handling and distribution can be potentially life-threatening.
Without the right monitoring program in place, the number of pharmaceutical products harmed by incorrect timing and temperature can be difficult to pinpoint. Temperature management for drugs is based on adhering to the product’s label claim during distribution and storage. A label’s claim is determined by the pharmaceutical manufacturer. The stability data for a product then sets the maximum amount of time out of boundaries allowed for maximizing product integrity and efficacy.
By the time products reach the wholesalers, pallets are broken up and products are combined with other products whose label claims may differ. Temperature monitoring for quality and integrity purposes may be a challenge at this point.
Pharmaceutical enterprises can and should take a holistic approach to their supply chain logistics. This starts with a defined logistics team and clearly defined standard operating procedures that are rooted in thorough risk assessments in order to take action, all before a product enters the market. Real-time temperature monitoring technology enables these designated stakeholders to pinpoint environmental conditions, monitor temperature and time, and strengthen product integrity.
While real-time technology can be used to continuously monitor the supply chain and even to educate temperature-controlled logistics management on its importance for efficacy to the patient, its benefits can be seen during the validation process as well. If a transport validation is done incompletely, poorly, or not at all, it can result in high risk for temperature excursions that affect the products and can be potentially harmful to patients.
Stability studies investigate product characteristics for extended periods to determine shelf life and required environmental conditions, including temperature. Storage and transport studies look at the speed at which the product moves and the environmental conditions it will encounter throughout the journey.
Pharmaceuticals with temperature-sensitive and shelf-life concerns deserve the most experienced, extensive, and expedient attention. However, that does not ensure their quality and safety unless they are packaged correctly.
Across the supply chain, packaging safeguards pharmaceutical products from external influences and foreign materials. During the shelf life of a product, the packaging helps ensure that claims made on a product’s label can be ascertained through a variety of environmental conditions. To ensure that pharmaceutical packaging is functioning as required, validation needs to be planned and executed before a pharmaceutical product is available in the marketplace, and it must be continuously monitored during the full lifecycle of a product.
Shipping route and packaging validation generally are designed to ensure that risk in the supply chain is sufficiently mitigated and pharmaceutical products are safe for consumption. Temperature monitoring is critical even at this point to ensure that packaging is working as required and that product labeling is accurate. A real-time monitoring and visibility solution can connect time, temperature, and location data in real-time and provides more granular insights into what happens during a product’s journey.
Every year, more pharmaceuticals are traveling throughout the supply chain via air, road, rail, and sea. Each handoff point poses different risks. Exchanges and drop-offs may require many modes of transportation and points of communication. Bad weather can cause delays, as, too, can hangar and dock delays, with shipments waiting in a plane or ship that is too cold or in sunlight that is too hot.
Communication and transparency are key when cargo is transported between multiple stakeholders across the supply chain. A collaborative approach is necessary. This helps clarify expectations from the outset, and minimize risks and challenges for all types of freight within the supply chain. It also results in stakeholders having a greater understanding of the concerns of pharmaceutical companies and better understanding the complexities that occur throughout the pharma logistics chain.
Utilizing the right technology to monitor and connect stakeholders through a single source of supply chain truth, including manufacturers, freight forwarders, and logistics providers can help all participants to improve their operations, drive efficiency, and mitigate risk.
The last thing any stakeholder wants is a package delivered after the expiration date, or a crate with frozen gel packs that had slipped off of a product in transit, raising the risk of over-heating. Worse is when a product has reached its destination and no one has noticed these issues.
Monitoring the temperature, location, and timing of shipments along the supply chain ensures compliance as much as it detects weaknesses and errors. With real-time technology, these issues are known as soon as they happen and before they escalate into something more severe.
Perhaps an intervention is needed at that time. For instance, reroute the shipment, reposition shifted packaging, or readjust temperatures. Today’s sophisticated monitoring programs assess distribution as a process—over time and in real-time—helping to distinguish between unexpected events and predictable trends. The collected data can be used to inform needed changes, improve quality control, meet regulatory requirements, and reduce costs.
Controlant’s real-time Cold Chain as a Service (ChaaS)® solution recently was used to validate the year-round packaging and lanes for a global pharmaceutical enterprise’s launch product in the UK and Nordic regions. This included access to Controlant’s real-time temperature loggers and its cloud-enabled software platform, where shipment data could be viewed and reported on in real-time. In total, 150 shipments were monitored over a two-week period during the wintertime and 2 weeks during summertime for seasonal variations.
During the trial, Controlant’s real-time supply chain solution captured time, temperature, and location information regarding the trial shipments and automatically delivered data to Controlant’s cloud-enabled software platform. Information regarding a single shipment as well as all supply chain shipments could be viewed on-demand.
In the case of a temperature deviation, an alert was sent immediately to the software dashboard as well as to designated stakeholders via email and SMS so that proactive corrective action could be taken to prevent a temperature excursion and product wastage.
Critical shipment data was available in real-time throughout the shipment. Shipment data for the entire winter and summer trial was available through the Controlant software platform immediately upon delivery of the final shipment for each season. Available supply chain data included product temperature throughout the shipment, lead time, markets, and packaging types (boxes) used.
Ada Palmadottir is Business Development Director at Controlant. With more than 20 years of experience in pharmacy, management, and technology, Ada has extensive international experience in sales, operations, and marketing, specifically in the areas of product, vertical alliance sales, and partnerships related to pharmaceutical products. She is a licensed and experienced pharmacist and earned a Master of Pharmacy from the University of Iceland and a Master of Business Administration from the Norwegian School of Management in Oslo. Ada has been working with Controlant for the last eight years.
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