End-to-End Kit & Box Level Monitoring

For decades, the collection, storage, and transport of human biological specimens has formed an integral part of pharmacological trials, medical treatments, and epidemiological research. However, in recent years, cellular gene therapy (CGT) and vaccination programs have increased the demand for super-chilled or cryogenic shipping conditions and end-to-end monitoring.

At the same time, the regulations relating to the management and transport of specimens, vaccines, and temperature-sensitive pharma products have taken on particular importance. Around the globe, guidelines now set out recommended protocols and approved practices in the growing area of bioscience.

Below, we discuss the implications for logistics and transportation. First, you will find an overview of the types of biosamples before we consider packaging, kit level monitoring, and the challenges involved. We also cover Direct-to-Patient applications and its associated practicalities.

Temperature Monitoring of Biological Samples

Given that regulations require the transport and storage of biological samples under strict environmental guidelines, end-to-end monitoring is indispensable. Sample viability and usability depend on qualified supply chains and adherence to standards.

As the maxim has it, laboratory results can only be as good as the quality of the specimen(s). Therefore, from collection to delivery, biological samples must stay within the specified conditions.

Types of Sample

The type of sample depends on the purpose of each test. For instance, blood glucose tests diagnose and monitor diabetes. In contrast, urinalysis for glucose content is usually to confirm urinary tract infections and kidney disorders.

Medical sample types include:

• Blood (the most frequently requested).

• Saliva.

• Sputum.

• Urine.

• Feces.

• Semen.

• Plasma.

• Bodily tissue, such as biopsy excisions.

Recommended storage temperatures vary in line with the sample type and preservation method. That is why constant kit level monitoring is essential. Some samples are susceptible to slight temperature fluctuations and, as a result, quickly degrade and lose their integrity.

The interior of a refrigerator, typically between 0°C and 4°C, is adequate for processing fresh specimens. However, short-term DNA stability requires sub-zero temperatures from -0.5°C down to -27°C.

For DNA/RNA stability over the medium to long term, colder conditions between -40°C and -80°C are necessary. Tissue storage calls for liquid nitrogen and super-chilling to the -130°C to -150°C range to preserve cellular viability. Finally, the storage of living cells requires cryogenic temperatures of -196°C.

Challenges in Handling Laboratory Samples

Complete blood count (CBC) tube sample storage should be at room temperature and transported within 24 hours. Also known as EDTA tubes, a term which refers to their chelating agent, these samples should remain at around 20 °C to minimize the risk of platelet and cell clumping.

Blood cultures also require room temperature conditions; some bacterial pathogens are not viable when refrigerated. Therefore, couriers should use different containers if necessary and adjust their procedures for the summer and winter months.

Additionally, some types of samples require storage in certain positions. Specifically, spun blood tubes should be upright to promote clot formation if no additive is present. This vertical positioning prevents contamination from prolonged contact with the stopper and aerosol formation when uncapping the tube.

Adhering to temperature limits is usually relatively straightforward within hospitals. However, healthcare providers with multiple locations and outreach programs at a considerable distance from laboratories tend to experience practical challenges, especially in keeping samples and products at viable temperatures while awaiting pickup or during delivery delays.

In such scenarios, rigorous control measures must be in place to prevent inadequate procedures or oversights from causing problems. At worst, unsatisfactory end-to-end monitoring of cold chains can scupper entire investigations or treatment programs.

Direct-to-Patient Application

This term means the delivery of drug medication or CGT to patients at home. Depending on the treatment or medical trial, patients may take medicines themselves or receive clinical support from a home care nurse or caregiver.

Similarly, biological samples or biopsies are taken and collected while the patient is at home. Direct-to-Patient models work well for commercial therapies, such as chronic illnesses and lifesaving treatment.

Importantly, this approach addresses two recurrent problems in clinical trials: patient recruitment and retention. Also, pharma companies can access a broader population instead of focusing on patients near medical centers, investigation hubs, or treatment clinics.

Although patients may need to visit a hospital initially to assess suitability and safety, they travel less during most of the trial. As a result, costs are lower, while sponsors can expedite timelines and market the product(s) that much sooner.

Although the Direct-to-Patient approach offers benefits for patients, manufacturers, and healthcare providers, it also presents challenges:

• Varying country regulations based on global good distribution practice (GDP) and other guidance.

• Delivery and pick-up required within predetermined – often narrow – time limits.

• Integrity of the cold chain.

Even one single temperature excursion or delay in delivery could pose health risks.

How to Monitor the Temperature of Samples

Chemical Indicators

Chemical temperature indicator strips, also known as high temperature ascending (HTA) labels, are relatively inexpensive for monitoring temperatures to confirm product integrity during transit and storage. The stickers enable personnel to verify that the consignment has not exceeded the set maximum. When attached to each box at the factory or laboratory, staff can confirm its correct condition at every transfer point from the medical laboratory to the operating room, doctor's office, or patient's home.

While chemical indicator strips are inexpensive and easy to use, they show relatively little information. Their response is quite slow, so they may not record a visible trace of temperature spikes of a short duration. Also, they are not as accurate as electronic devices.

Electronic Temperature Indicators

For better end-to-end monitoring, electronic indicators record more data and provide downloadable statistical reports via cloud storage. Examples such as the LIBERO ITS are cost-effective over their typical service life of four years.

Available in cool room, no-freeze, WHO, and customizable temperature profiles, the LIBERO ITS is GAMP 5-validated and individually traceable.

Conclusion

Companies and organizations that store or transport pharmaceutical products, medical equipment, and human biological samples have to comply with local and/or international regulations.

ELPRO specializes in pharmaceutical compliance and end-to-end monitoring solutions. For further details of kit level monitoring for your supply or logistics chain, please contact us.