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7 Logistics Questions to Answer When Updating Your Practices

Some seemingly costly cold chain updates can save millions in products losses, transportation costs and more. On the heels of award-winning and sustainable improvements, Cardinal Health and Sonoco ThermoSafe discuss the opportunities and concepts to consider.

Though robust cold chain infrastructure and product protection are critical, it can be difficult to get major changes off the ground, particularly when your organization has been using the same methods for years. “Cold chain packaging will NOT add value to a pharmaceutical shipment,” said Frank Butch, Director of Engineeringat Sonoco ThermoSafe, during his talk at the Healthcare Packaging & Processing Conference co-located with PACK EXPO East in Philadelphia. “Cold chain packaging will preserve the value.”

When new packaging or protocols appear to be more expensive at face value, they can be hard to justify to those holding the purse strings. The first priority must always be product safety, quality and regulatory compliance, but there can be financial advantages to cold chain updates as well. Chris J. Anderson, Director of Quality Systems at Cardinal Health, also talked strategy at the Healthcare Packaging & Processing Conference, including what worked when Cardinal implemented their own award-winning cold chain improvements with efforts from Sonoco ThermoSafe. The two experts brought up many important considerations:

  1. Which standards or criteria will you comply with?

With only a few industry standards as guidance for packaging such as ASTM 3103 and ISTA Standard 20, you must decide which tests you’ll run and your acceptance criteria. Which probing locations and testing conditions will you use, particularly if you have distribution channels in different climates? “Finding a hard and fast rule will be very tough for the organization,” said Butch. Anderson added that only five states use words for temperature-controlled shipping, and they are typically vague, so there is no clear regulatory language to follow.

There’s a difference between acceptance criteria from 2 to 8°C versus 1.6 to 8.4°C, and

moving the criteria from 8.0°C to 7.5°C doesn’t necessarily make the design better for your product and situation.

And just as a swimming pool changes temperature slowly compared to a small cup of coffee, a bulk product shipment will change more slowly than a single pre-filled syringe; it’s important to select an appropriate load representation for your product and look at product placement. If the product is far from refrigerants (such as in a large packout) and close to an uncovered wall, environmental heat will affect it more quickly. Data loggers are very sophisticated, but an air temperature measurement near a syringe or small product will offer you a more accurate picture of the total product than a single measurement near a bulk API shipment.

Butch also reminded attendees to keep in mind that some pharma products may include ancillary syringes, CDs and other educational materials.

  1. Along these lines, what is an appropriate temperature profile?

The temperature profile should match the shipping lane, so only testing to the harshest condition may not be cost-effective. “More extreme profiles aren’t always better, they’re just tougher,” noted Butch. “If you only ship to Alaska once per year, you’re better off designing a specific Alaska shipment and driving the cost down for standard U.S. shipments.”

In the debate between universal packouts versus seasonal, seasonal will always be less expensive, but that option does increase your risk. Then there are decision points: if your company uses a winter packout from January to April, what will you do on a 70° day in mid-March? Can your operations procedure be flexible enough to say that you’ll use a summer packout on a 70° winter day?

On the flipside, Butch explained the need for clearly defined procedures. If an employee adds an extra gel pack on a hot day, but the packout was already designed for that temperature, the extra pack may freeze the product. “Everybody’s trying to do the right thing. [Employees] shouldn't have to be making judgement calls along the way,” he said. The proper procedure for a given condition “should be built into the design and operations.”

  1. What does an excursion mean to your organization?

It may seem obvious, but in order to identify and mitigate excursions properly, you must have clear definitions upfront. You don’t want to leave excursions up to interpretation when issues come up.

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