The vital role of temperature indicators in pharmaceutical packaging

Throughout the journey from production to consumption, attention to detail is a must, especially concerning temperature control. Even the slightest deviation in temperature can compromise medications, rendering them ineffective or, worse, hazardous to patients. Therefore, it becomes crucial to address the challenges posed by the ‘last mile’ of deliveries, where temperature maintenance is critical.

With that said, here’s all you need to know about temperature indicators and their role in protecting pharmaceuticals.

Why temperature control for pharmaceuticals matters

Pharmaceutical products are often sensitive to temperature variations. Many medications, vaccines, and biologics require specific storage conditions to maintain their stability and effectiveness. For example, vaccines like those used during COVID-19 needed to be stored at precise temperatures to prevent degradation of their active ingredients.

For many medications, exposure to temperatures outside of the recommended range can lead to loss of potency or even harmful changes in the composition of the medication. These alterations can, unfortunately, pose serious health risks to patients.

That’s where temperature indicators step in.

The role of temperature indicators in pharmaceutical packaging

Temperature indicators act as guardians, providing evidence when pharmaceutical products have been exposed to temperatures above or below a chosen threshold.

These indicators come in various forms, including labels, tags, and electronic devices, each designed to suit different packaging requirements.

• Temperature indicator labels: These are simple, cost-effective solutions that change color or display a message when exposed to temperatures outside of the specified range. They are often attached to individual packages and provide visual cues to indicate whether the product has been subjected to poor conditions.
• Electronic data loggers: More advanced temperature indicators, these devices record temperature data over time and can provide detailed reports of temperatures. They are particularly useful for sensitive products that require strict temperature monitoring throughout the supply chain.

However, given their cost, electronic data loggers are typically used per pallet, meaning individual shipments do not benefit from the physical evidence provided by temperature indicator labels.

The benefits of temperature indicators

By incorporating temperature indicators into pharmaceutical packaging, manufacturers and distributors can take proactive measures to safeguard product integrity, protect consumers, and even save on costs.

• Quality assurance: Temperature indicators play a crucial role in quality assurance by providing evidence of proper storage conditions throughout the product's journey. This data is invaluable for regulatory compliance and quality control processes.
• Supply chain management: In the complex network of pharmaceutical supply chains, temperature indicators help track the environmental conditions to which products are exposed during transportation and storage. This visibility enables timely interventions to prevent temperature-related damage and ensure that medications reach patients in optimal condition.
• Cost savings: WHO estimates that the use of temperature indicators could reduce wastage rates by up to 30%.
• Easy decision-making: Users can quickly tell which products are safe to use, minimising the risk of unsafe drug consumption.

Examples of temperature indicators

• WarmMark: a single-use temperature indicator that notifies handlers about adverse temperatures. WarmMark has a temperature accuracy of ±2°F and is suitable for many cold chain monitoring applications including test specimens, medicine, vaccines and more.
• FreezeSafe: descending, single-use temperature indicator that provides accurate, irreversible evidence if a product has experienced unacceptably low temperatures. The indicator will turn from white to magenta if the temperature goes below a predetermined threshold of 0°C / 32°F or 2°C / 36°F.
• ColdMark: a single-use descending temperature indicator designed to help shippers identify gaps in the cold chain. ColdMark will turn from clear to violet when the temperature drops below a predetermined threshold.

Temperature indicators for pharmaceutical products

At Swiftpak, our wide range of temperature indicators is designed to meet the diverse needs of pharmaceutical manufacturers and distributors. From cold chain through to frozen products, we can help ensure the integrity of your shipment.

For more information on our temperature indicator range, contact Swiftpak today – we’re always happy to help and answer any questions you may have.