Temperature Validation Package Integrity Testing

Temperature Validation Package Testing

As an ISTA and ISO 17025 certified lab, we realize the importance of temperature transit testing. We understand the challenges and guide companies through the process. Our proven process helps avoid product launch delays. Keystone Package Testing creates an accurate test plan to eliminate expensive over-testing.

Request a quote to receive testing services customized to your specific needs. Contact us to receive more information on temperature validation testing.

Why is Temperature Validation Package Testing Important?

The objective of temperature validation regulatory compliance is to ensure consistency. Many packaged products must remain in tight temperature tolerance. If the temperature is not maintained, the product’s integrity can be jeopardized. The process of thermal validation is complicated, but our experts know the process and understand thermal validation requirements.

Thermal testing is most often associated with cold chain package testing. The term cold chain reflects the supply chain a product must go through. This process starts from manufacturing or harvest. It continues through distribution and storage. It ends upon delivery to the customer. One problem along the way can be catastrophic.

Types of Packages Tested

Temperature validation package testing can be completed on single units or multiple packed units. It can also be conducted on entire pallets or containers. When testing multiple units, temperature mapping is required. Thermal mapping provides insight into potential weaknesses.

Thermal mapping is critical for quality control and regulatory compliance. This method uses data loggers to track temperature and humidity, ensuring the safe transport and storage of temperature-sensitive items like vaccines and food.

For example, in ISTA 7E testing, products are exposed to temperatures ranging from -20°C (-4°F) in winter scenarios to 40°C (104°F) in summer scenarios, encompassing the extreme conditions likely encountered during shipping.

Larger quantities can present challenges. For example, outer units typically are more susceptibe to external conditions. Units at the top of a load experience greater temperatures than those on the bottom or in the middle. This is especially true if stored outdoors in the sun. On the other hand, units in the middle sometimes get too cold. This can occur from overpacking.

During cold chain verification, various positions will be evaluated. This is conducted using data loggers and thermocouple systems. Data is recorded throughout the temperature test. The validation master plan will determine the external environment. Cold chain verification can involve both hot and cold temperatures. Thermal shock conditions can also be used.

Once completed, the thermal modeling data is analyzed. Areas of weakness are addressed. If the cold cargo requires additional cooling, dry ice or other materials can be used. During refrigerated package testing, various package designs are often evaluated. Cold chain validation is a process of elimination and fine-tuning.

It is important to note that even single packages can have thermal qualification issues. Some products and packages might have cold or warm spots. These spots could cause product failure.

Industries That Require Temperature Validation

Any industry can require thermal validation package testing. However, it is more prevalent in some industries. The food industry is one example. Some food must remain frozen at all times. Frozen food package testing can identify potential issues. Packaged products are placed in a chamber. The chamber is the set to expose the product to heat, humidity and/or solar radiation.

Results of the frozen food shipping test can be compared to that of other packages. If failures occur, solutions are available. One item to consider is the packaging material. This includes both internal and external. The product position could be explored. The number of packaged units could be modified.

Unlike consumer product testing, pharmaceutical shipping tests have two failure ranges. If frozen food gets too cold, it is rarely a problem. The same is not true with many medicines. Thermal verification of medicine can be very challenging. Not only can it not get too hot, but it also cannot get too cold.

Pharmaceutical package testing must consider both. A medicine that becomes too warm might become inactive. This is especially true for vaccines. Conversely, medicines that get too cold can separate. These medicines can also become ineffective. For this reason, the pharmaceutical transport tests involve more detailed cold chain modeling.

Temperature Modeling

To understand the package validation requirements, it is important to first understand the distribution environment. The best way to do this is by collecting data. First, thermocouple probes and data loggers are needed. These will record the response of the package during transit.

It is ideal to test packages for various conditions. For instance, record data for each shipping route. Companies should test packages year-round. Data from all seasons should be collected. External conditions should be recorded as well. This will improve the use of the data.

Once the data is collected, package changes can be assessed. Each failure should be reviewed. The goal is no temperature excursions. All such events should be recorded. The root cause must be found. Only once that happens can failures be solved.

Improvements to Cold Chain Packages

There are various ways to improve performance. From a container standpoint, insulated shipping containers should be used. When needed, specialty containers can also be used. From a vehicle standpoint, there are many options. Refrigerator trucks are the most common. Other vehicles include reefer ships and reefer containers. Warehouses should be temp-controlled.

Packaging material can have a big impact. Using too much can increase shipping costs. Using too little can cause failures. The right material must be a mix of performance and cost.

Industry Leading Temperature Validation Testing Laboratory

Keystone Package Testing can help you realize the benefits of package validation. We are temperature validation testing experts. Our team tests hundreds of products each month. The insight gained assists in package design and failure analysis.

We offer short lead times to get into the lab. Our reports are thorough and delivered quickly. Our pricing is affordable and we offer volume discounts. Additionally, our fleet of thermal chambers and shakers can test any sample size.

Ready to get started? Request a quote from us. If you are looking for more information about our testing capabilities, contact us. We look forward to working with you to help you certify your packages through our streamlined process.