5 Tips to Minimizing Risk in Your Cold Chain Packaging

As pharmaceuticals have become more and more regulated, companies have had the need to build or evaluate their cold chain processes and packaging to comply with those regulations. The challenge with those regulations is that although they may provide guidance, they may not be optimized for your region of the country, for the type of carriers you use, or the sustainability standards that are demanded by consumers and governments alike. So, how do you navigate through these issues while still keeping your eye on profits and patient safety? Below are 5 tips to ensuring your packaging and processes meet the needs of your company, your customers and your compliance standards:

1) Cold chain integrity. Where is your weakest link?

You can dot every "i" and cross every "t", but unless you know where your gaps are, you are vulnerable. Medications get left in the sun, unexpected weather changes cause failures in equipment, temperatures can fluctuate from region to region. so how do you find that weak link and do you have the resources and time to resolve the issues? Document your risk priorities for every "touch point" in your process do determine precedence. Just like any situation, when overwhelmed, make a list.

Shipping studies and gap analysis are key projects you should look at for determining where gaps may occur. It forces you to look at the number of times your product changes hands, allowing you to assess the critical shipment hand-off points and manage the risk presented at these points. Once you have done that you can establish a quality system and validation protocol with your employees and carriers. This will also allow you to create a repeatable and transferable process for success. On a regular basis you would then need to review this protocol, test security measures, and determine if a robust program is still in place to mitigate the risk.

2) Is your packaging as effective as you think it is?

Prolonged delivery delays caused by transportation glitches, security inspections or customs scrutiny and seasonal or climate differences between origination site and destination can cause temperature fluctuations inside shipping vehicles & containers.To address this, today's specialized containers not only have longer hold times, but weigh less and meet the needs of green companies.

The technology is changing so quickly, that you should have your packaging evaluated annually to make sure it performs to meet your exact transportation processes, and does so with a full compliant documentation package (Temperature profile, CQ/DQ/IQ/OQ/PQ, gel pack conditioning process validation, and training material). Although the process sounds daunting, many companies have found cost savings through lighter weight shipments, fewer gel packs, and the ability to use lower cost carriers.

3) Make training an integral part of your management process

Since the inception of regulations, companies have found that in-house training programs are needed to keep up. The challenge is that these programs can be expensive and need to be customized to their organization’s specific shipping and receiving needs. Such programs include education on:

• Inspection/rejection guidelines
• Assessing temperature ranges for biological materials
• Documentation and audit trails
• SOPs for pre-conditioning packaging (+2 to +8 C shipments)
• Regulations and industry guidelines
• Supplier qualification for in-bound shipments
• Validated packaging options

Companies that do not have the in-house expertise or find that it is not cost effective to do so, develop and administer compliant training programs often contract with external agencies that specialize in compliance or dangerous goods and can provide training and certification.

4) Do you know the difference in regulations between countries or agencies?

Although the EU, US and Canada for example are similar in terms of quality standards, Canada has stricter standards than the US. That being the case, goods that travel between the US and Canada have to meet Canadian guidelines. US manufacturers, however, may not be aware of how to both meet country-specific regulatory needs and optimize shipping logistics and packaging to not "break the bank."

Companies that ship cross boarders should consider conducting a packaging analysis that starts with the compliance regulations before deciding on a new packaging solution. What that means is matching packaging and process specifications to compliance issues and determining where the gaps may lie, then modifying existing solutions or finding a new one that is tested and qualified. Standard, off-the-shelf packaging containers may be available that already fit your needs, however, without an audit of the regulations and specifications of your existing solution, you won't know what solution is available to you.

5) Overengineering your packaging does not mean it is better packaging

When was the last time you took the time to truly understanding your product and distribution process as it relates to your packaging? You may have never had a temperature excursion. Does that mean you don't have an issue or does it mean you may have over-engineered your cold chain packaging so much that it is costing you money in shipment weight, material, or refrigerant?

Fiscal responsibility comes from knowledge. And knowledge comes from data:

• During your packaging and design stages look for industry data that will help you optimized your spend on packaging. Technical reports, like those issued form the PDA can help save time evaluating shipping lanes (See Technical Report 58).
• With changes in weather patterns or when entering new markets, try conducting a temperature profile study that evaluates seasonal changes and their effects on your products. This will also evaluate both the packaging and the carriers.
• Determine the fiscal impact of packaging to the product itself. Over-engineering comes at price. Look at the transport process duration (24-hr; 48-hr), carrier type, container weight, packaging methods, insulated material, and shipping lanes as factors that can all be evaluated when determining the cost of the container.
• Have you tested for damage boundaries to understand what your product can withstand? If not, testing product stability can help determine where and when damage can occur so that you can use data recorders set to the right parameters or adjust packaging as needed.