In an increasingly globalized and temperature-sensitive supply chain landscape, maintaining product integrity from origin to destination is more critical than ever. The cold chain industry relies on a complex network of technologies, protocols, and logistics. To ensure efficiency, compliance, and quality assurance, companies must adopt and continuously refine best practices across every stage of the cold chain. This article explores ten essential strategies that industry leaders use to optimize performance, reduce risk, and uphold the highest standards of safety and sustainability.
1. Vendor QMS
Choosing cold chain vendors that have a Quality Management System (QMS) in place will ensure that the vendors already have policies and procedures for items such as risk reduction, efficiency improvements, complaint remediation, and product quality. The additional step of having an ISO certification can also decrease the amount of vetting required to include the vendor on your approved vendor list.
2. Consultative Vendors
Going a step beyond a QMS, choosing a vendor that can provide consultative services can give opportunities to enhance your day-to-day operations and improve the cold chain packaging that ships your products. Most cold chain companies today have subject matter experts (SMEs) on staff who visit different clients, attend conferences, and stay up to date with the latest regulatory requirements. These SMEs can provide valuable recommendations that solve problems and provide cost reductions in your operations while also staying compliant with regulations.
3. Risk Management
Managing the risks that a cold chain package is exposed to during transit can be key to ensuring a safe delivery of life-saving pharmaceuticals. Events such as extreme weather conditions and shipment delays can result in products experiencing a temperature excursion if not managed ahead of time. The impact of most risks can be greatly reduced by choosing cold chain packaging that is event-based risk conscious, building strong partnerships with your courier, and using risk management tools such as the FMEA.
4. Managing your Shipping Lanes
A step beyond managing general risks is managing the typical shipping lanes. Whether you have a handful of common lanes or parse your shipments into broad regions, ensuring that your lanes are being assessed periodically can be pivotal to reducing the risk of temperature excursions or damaged products. Monitoring ambient temperatures experienced by your cold chain shipment, recording events such as late or damaged shipments, and routinely performing Performance Qualification (PQ) and Process Validation (PV) throughout the year can reveal trends for future shipment successes or failures and provide opportunities to decrease the risk of temperature excursions overall in your cold chain shipments.
5. Mapping Conditioning Areas
The performance of conditioning areas for room temperature, refrigerated, and frozen items are critical for ensuring that pharmaceuticals do not experience a temperature excursion while stored inside your facility and that any cold chain packaging will perform correctly. Temperature mapping is a best practice for areas such as refrigerators, freezers, and open warehouses. Mapping consists of monitoring the temperatures for a period of time on the corners and faces of the areas where products are stored to ensure the typical working area can keep the required temperature range.
6. Matching OQ Testing Conditions to the Real World
Many cold chain packaging options will come with an “off-the-shelf” Operational Qualification (OQ) to prove that it can function correctly during typical use. While these shipping systems can be a great solution for your shipping needs it is still good practice to ensure that the qualification protocol matches closely to your real-world operations. Some important items to evaluate for their correlation to your lane management and mapping data include:
7. Using Calibrated Data Loggers
When performing certification on conditioning areas or cold chain packaging, it is crucial to check that the temperature monitoring device has been calibrated and certified for its function. Data loggers are now available on Amazon and other websites which are very inexpensive but may not be giving accurate results, following Code of Federal Regulations (CFR) requirements, or function correctly in a hot or cold environment. Verifying that your data loggers have been calibrated to the temperature range you require and that regulatory requirements have been considered by your data logger vendor will ensure accurate results that are presentable to auditors and governing bodies.
8. Packaging End of Life
After the delivery of medications is completed, the final destination of the cold chain packaging should always be considered. Expanded Polystyrene (EPS) insulation provides the best insulation and protection for temperature-controlled shipments, but recycling is typically only available by the manufacturer or in large municipalities. Shipments to more rural areas can lead to a garage full of EPS coolers in which case a curbside recyclable or compostable insulation such as EFP’s NatureKool® brand can ensure a sustainable disposal method is available. Knowing your clientele and choosing the correct sustainable packaging that matches your shipping method can help with landfill avoidance as well as push forward the environmental goals for your company.
9. Continuous Improvement
Continuous improvement is important to pursue for driving cost savings as well as sustainability initiatives. Periodically reviewing the performance of your cold chain packaging and evaluating risks can sometimes allow you to remove refrigerant weight that both reduces the carbon footprint of shipments and lowers the shipping cost. Alternatively, a more robust packaging option may be required if product is being rejected due to temperature excursion; this scenario will give savings over time by not having to ship replacement products or experience customer complaints. By balancing cost, performance, and risk on a regular basis, you can ensure your operation is utilizing the most optimized cold chain packaging solution for your shipments.
10. Industry Trends
To best facilitate continuous improvement, it is important to stay on top of industry trends. Attending trade shows will allow you to see the up-and-coming technologies in cold chain shipping. Watching webinars or attending conferences can give you a glimpse into new trends that are developing in the industry and also give networking opportunities to share best practices between peers. Periodically reviewing the latest guidelines and regulations will ensure that you are staying compliant but also not following outdated requirements.
For additional insights on cold chain best practices, reach out to industry experts at EFP.
Written by Andrew Klasek, Product Engineering Manager.
Andrew began his career in the Environmental Chemistry field before coming to the packaging world where he currently runs the EFP Cold Chain Laboratory which develops shipping solutions for pharmaceutical and food shipments. Andrew also participates in the creation of whitepapers and industry guidance documents with the ISTA Pharma Committee covering topics such as developing temperature profiles for testing, lane testing, and simulation software.
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