When it comes to moving pharmaceuticals, time is of the essence, shipment visibility and temperature monitoring is a necessity as the cold chain must never be broken. A slight change in temperature, even 2 degrees, can cause a pharmaceutical shipment to be rejected.
In 2020, North America’s pharmaceutical market accounted for more than 49% of the world’s pharmaceutical sales. According to Pharmaceutical Research and Manufacturers of America (PRMA), the pharmaceutical sector in the United States contributes $1.3 trillion to the world economy each year and employs nearly 4.5 million Americans contributing to the well-being and health of millions more people.
The pharmaceutical logistics business across the globe generates billions of dollars each year with the United States as the largest single pharmaceutical market in 2021 generating more than 550 billion dollars of revenue. As a shipper of pharmaceutical products, you know the stakes are high. Improperly set refrigerated containers, unexpected delays, theft, and related issues can cause damage or destruction of goods and millions of dollars in losses. Or worse, a compromised shipment could lead to fatal consequences for an end user.
With so much at stake for all involved parties, we would like to explore the world of pharmaceutical transport from the shipper’s perspective. We will detail TydenBrooks’ end-to-end cross border cold chain security, monitoring, and damage prevention solutions to protect the integrity of your shipments.
Protecting Sensitive Pharmaceutical Freight
Proper packaging and handling of pharmaceutical shipments can be the difference between a ruined shipment and happy customers. As medicinal products are exceedingly fragile to transport, should the contents inside be damaged or tampered with in any way, there’s a good chance the products can no longer be used or sold. It’s therefore important to utilize a layered security approach of tamper-evident cold chain security and monitoring solutions to promptly identify and mitigate problems when they occur.
Beginning with damage prevention, TydenBrooks single-use, go/no-go ShockWatch® 2 impact indicators are a cost-effective solution to alert if fragile pharmaceutical products have been dropped during transit or while in storage. The indicator is a field-armable, tamperproof device that turns bright red when an impact beyond a specific threshold has occurred. The TiltWatch® XTR is single-use tip indicator used to monitor goods that must remain upright. Once a shipper applies it to the packaging, the TiltWatch XTR will provide evidence of mishandling if the shipment is tipped. However, the tilt indicator remains unaffected by movement resulting from normal handling conditions.
For an advanced damage monitoring solution, our complete line of connected GPS TydenTrackers utilize device or tags data with advanced analytics and automations to monitor and report changes in light, movement, and shock as it moves through the supply chain. The tracking of each shipment through every stage of the pharmaceutical transport process is achieved with our customizable TrackSecure platform.
Shippers are equipped with real-time visibility and alerts to automatically identify and track the location of their cargo and equipment. These “active” devices can be embedded into the freight including cartons to provide instant visibility at the case level. Both solutions are available for use as a standalone device or in combination with our BLE Tyden Tags creating an expanded sensor network.
While there are a lot of moving parts that go into producing medications, its equally as important to maintain safety and potency through ‘climate control’. The efficacy of pharmaceutical products is reduced by prolonged exposure to high temperature, light, humidity, and moisture. Strict regulations have been put in place by the World Health Organization (WHO) to protect public health on a global scale. The WHO recommends maintaining relative humidity levels around 50 percent. If levels climb above or dips below 50 percent, there can be detrimental effects on the quality, yield and shelf-life of the product.
When products do not maintain the right temperature or humidity, they could become ineffective and even harmful to the patients that receive them. Pharmaceuticals have diverse and individualized properties that must be taken into account with each cross-border shipment. There are substantial risks to patient health from improperly transported pharmaceuticals. Numerous laws and regulations governing pharmaceutical products, from the UN, US Food and Drug Administration, and Drug Enforcement Agency, as well as state and local guidelines have strict regulations of temperature, humidity and in some cases exposure to light and vibration.
These are general rules of thumb for medication, but some drugs have more specific requirements. Insulin used to treat the effects of diabetes needs to be kept between 36 and 46 degrees Fahrenheit, or 2.2 and 7.7 degrees Celsius, when not in use. While in use, it can be stored between 56 and 80 degrees. Should these guidelines fail to be met, insulin will be reduced in quality. This is just one example but there are several different kinds of drugs that must be temperature controlled or they will be rendered ineffective.
By utilizing our single-use WarmMark ascending time-temperature indicators, shippers will be alerted of exposure to unacceptably high temperature conditions and the cumulative amount of time of the exposure. The WarmMark family of temperature indicators provide accurate, irreversible evidence of any above temperature deviation allowing you to make smarter decisions for your cross border pharmaceutical shipments. For an advanced solution, our TydenTrackers provide a sophisticated end-to-end solution. Not only do they monitor light, motion, and shock, but they also monitor temperature, humidity, and moisture, sending alerts in real-time when preset tolerances are breached.
Pharmaceutical Freight Theft Prevention
Manufacturers and shippers of pharmaceuticals know it’s an absolute necessity to have solid theft prevention protocols in place. Not only do cross-border shipments carry a high value, if stolen, they could end up in the wrong hands and have serious consequences for a manufacturer and shippers reputation. Moreover, packaging that clearly states what is inside can be an invitation to potential theft or pilferage. Nondescript packaging with no mention of the product inside will be less appealing.
For anonymity with a layer of tamper-evident security, shippers should utilize our non-branded covert KTC void message security tapes. The KTC offers a design option to look like a normal box tape until it’s removed revealing a security message underneath. Security messages are customizable and can come in multiple languages. Additionally, with temperature sensitive pharmaceutical products, we have the option of irreversible thermochromic inks. Thermochromic inks turn transparent when heat is applied and can also detect temperature history during shipping.
Rounding out a complete theft solution, its necessary to create a physical barrier to ensure your pharma shipments are a difficult or unappealing target. Your best mechanical security seal options are ISO 17712 high security cable or bolt seals which will restrict access to your cargo and must be removed with a cutting or removal tool.
High security ISO cable seals, such as our EZ Loc and EZ Loc Plus, are the ‘gold-standard’ comprised of durable die-cast zinc and our patented ball-bearing locking mechanism that forces the ball down into a locking chamber when the cable seal is locked. Our patented locking mechanism prevents a compression attack, where any attempts to rachet out the cable and reinsert without tamper evidence is mitigated. The over-molded EZ Loc Plus offers additional customized marking options such as, 1D, 2D, and QR barcodes as it comes standard with an encapsulated plastic ABS body. Both EZ Loc versions use a non-preformed security cable that frays when cut to prevent reinsertion and to show evidence of tampering.
Bolts seals, such as our Snaptracker and Intermodal II are designed for cross-border and high-value high-risk container rail and trailer shipments. They are also regularly utilized for international container shipments. All our bolt seals meet or exceed the ISO 17712 standard and require bolt cutters for removal. Marked by high security lasers the ability to customize the bolt seals with 1D, 2D, and QR barcodes allows for unique company identifiers. This ensures their authenticity and chain-of-custody tracking.
Leading the Way, Securing the World
A pharmaceutical supply chain is full of complexities and can be unpredictable. Tracking alone isn’t enough. Today’s cross border shipments require a complete turn-key supply chain monitoring and security system with real-time visibility.
Speak to our team of supply chain security experts with a free no obligation cross border pharmaceutical shipment consultation. Contact us at 1-800-458-7325 (SEAL) or [email protected] and remove the uncertainty.
