Shipping temperature-sensitive pharmaceutical products is persistently challenging, often requiring specialized packaging solutions, strategic planning and reliable partnerships. As the demand for refrigerated pharmaceuticals like Ozempic and Wegovy continues to grow, pharma businesses may need to navigate challenges in new ways to meet customer needs.
Some of the most pressing challenges in drug product shipping include:
1. Preventing Temperature Excursions in Dynamic Environments
Temperature management is a significant challenge in biopharma processes. Many types of biopharma products, including rheumatoid arthritis medications like Humira and mRNA vaccines, require refrigerated temperatures of 36 F to 46 F. Deviating from this temperature range can compromise product efficacy, ultimately leading to waste and financial loss. Temperature excursions cost the biopharma industry $35 billion yearly.
Numerous factors can cause temperature excursions, including unforeseen traffic delays, fluctuating weather conditions and miscommunication. When shipping involves multi-modal transit, temperature management becomes even more complicated, with additional opportunities for cold chain disruptions. Shippers that lack access to real-time temperature monitoring data may face greater difficulty detecting and addressing excursions promptly.
2. Navigating Complex and Evolving Regulations
Navigating domestic shipping regulations and standards, such as those established by the Food and Drug Administration, is challenging in itself. Add global shipping to the picture, and regulatory compliance becomes even more complicated. Global pharma shippers are expected to follow guidelines set by the International Air Transport Association and World Health Organization — in addition to country-specific regulations.
Understanding which regulations apply is only part of the challenge. Pharma businesses must also determine how to ensure compliance across locations and potentially thousands of monthly shipments. Compliance often requires robust, standardized management and monitoring processes.
Businesses must also be agile and ready to adapt to new or modified regulations. Noncompliance with shipping regulations can generally lead to fines, reputational damage, public health consequences or lawsuits.
3. Handling Last-Mile Delivery Risks
The last mile can be the most challenging step in shipping pharmaceuticals, particularly in rural areas or developing countries. Limited infrastructure, connectivity issues or theft are just some of the problems drivers may face. Any disruption can prolong transit duration and lead to temperature excursions or prevent delivery altogether.
Contingency plans, reliable partnerships and strategies for maintaining oversight can help mitigate the risks of last-mile deliveries both globally and domestically.
4. Balancing Cost and Sustainability With Performance
Pharma shippers face the challenge of finding the most cost-effective shipping methods while maintaining compliance and product quality. As carrier rates continue to increase, that challenge becomes greater.
Generally, finding the right balance between cost and risk requires understanding each product’s storage requirements and shelf life. It also involves knowing how to strategically plan deliveries, taking temperature control and regulations into account.
Increasingly, businesses must also consider sustainability when making decisions. The number of consumers and investors expecting more sustainable packaging and delivery methods is growing. For example, according to Statista Consumer Insights, over 50% of survey respondents in five of eight countries say that eco-friendly packaging is an important part of sustainable consumption. Reducing waste and decreasing carbon footprint while preventing temperature excursions is yet another challenge that requires innovative solutions.
Overcoming the Challenges of Shipping Pharmaceuticals
Just as there are many challenges in pharma shipping, there are plenty of ways to overcome them. Today’s businesses can embrace innovative solutions ranging from high-tech monitoring technology to cost-effective refrigerants to tackle common obstacles. Consider these strategies:
1. Analyze and Enhance GDP Compliance
How well do your managers and employees follow good distribution practices (GDP)? Do you have comprehensive contingency plans for mitigating unexpected delays and temperature excursions? Are standard operating procedures (SOPs) and training materials up to date?
Consider performing a gap analysis to evaluate your business’s GDP compliance and identify areas for improvement. A gap analysis usually begins with determining the objective of the analysis, then transitions to looking at data and analyzing current processes.
For example, if your goal is to reduce temperature excursions, your gap analysis might involve analyzing temperature logs and monitoring device calibration records to identify the cause of the deviations. After you uncover the root cause of a temperature control issue, you can determine ways to address it.
2. Implement a Robust Gel Pack Program
Gel packs are cost-effective solutions for maintaining temperature control in hybrid and passive packaging systems. Additionally, there are special gel packs that are safer and easier to handle than dry ice.
Whether facing temperature control challenges or considering expanding into new markets, a robust gel pack program can help your business get ahead. Incorporate gel packs with the following steps:
- List and profile products: List and describe temperature-sensitive products, including their temperature range and humidity requirements.
- Identify common shipping routes and risks: Consider where you frequently ship products, the transit duration and the typical weather conditions. Pinpoint risks commonly encountered on each route.
- Select gel packs: Look for gel packs that meet your package size and shape requirements as well as your required temperature range. Consider eco-friendly options to progress on sustainability goals.
- Request samples and validate: Ask the supplier for samples so you can test your chosen gel packs in real-world conditions and validate them before ordering a large supply.
- Update SOPs: Once you’ve found the right solution, develop procedures for using gel packs, such as how to condition them and place them in shipping containers. Update your SOPs accordingly.
3. Improve Temperature Monitoring Capabilities
Are employees or partners struggling to prevent temperature excursions? Whether you’re currently facing temperature issues or wish to proactively address risks, consider if it’s worth investing in sophisticated monitoring technology. Advanced hardware and software solutions may provide real-time temperature monitoring, predictive analysis and automated temperature control.
For example, you can place internet-connected sensors in shipping containers and easily collect real-time temperature data. Managers or drivers can receive automatic alerts if an excursion occurs.
AI-powered monitoring devices can analyze historical temperature data and predict a future excursion so your team can take proactive steps to address it. Numerous advanced technological tools are available to help you quickly identify and address temperature concerns related to pharmaceutical shipping.
4. Develop Strong Partnerships With Cold Chain Experts
Are there ways to tap into the expertise of your supply chain partners? Whether you work with software companies, logistics providers, packaging suppliers or others, consider if there are ways to make each partnership more collaborative and fruitful.
For example, Pelton Shepherd is more than a gel pack manufacturer — we also offer cold chain solutions like our Conditioning Operations, Logistics and Delivery (COLD) program. Additionally, we take a solutions-focused approach to partnerships, helping our customers select the correct refrigerants for their temperature control needs, which may include recommending custom solutions.
Regardless of who you work with, developing more collaborative partnerships can help you achieve a reliable supply chain and reduce risks like temperature control failure or route delays. If you need to obtain new partners, look for businesses that prioritize excellent customer service, innovation and transparency — they are most likely to enable lasting, beneficial relationships.
Partner With Pelton Shepherd for Reliable Temperature Control
From consistently maintaining temperature control to ensuring compliance with various regulations, pharma shipping companies have plenty to contend with. At Pelton Shepherd, we understand the challenges cold chain shippers face and have developed solutions to address them.
Whether you require innovative gel packs or long-term logistics support, we’re committed to meeting your temperature control needs. Contact us today to learn more about our solutions or request a quote.
