The COVID-19 pandemic has once again drawn attention to the importance of cold chains. Cold chains are temperature-controlled supply chains. In the pharmaceutical industry, cold chains are often used for handling patient samples as well as treatments like vaccines. On the patient sample side, a cold chain preserves sample quality from the time it’s acquired until it reaches the lab for testing. For vaccines, a cold chain maintains product quality from the time of manufacture until the vaccine is administered.
Cold chains typically involve a series of devices and logistic solutions designed to maintain the proper temperature for a sample or vaccine, including refrigerators, freezers, temperature monitoring devices, and more. Managing the cold chain is critical to maintaining the integrity of the material. In many cases, a laboratory information management system (LIMS) can streamline the management process.
One company using LIMS to manage its cold chain is Examen. Examen is a growing diagnostics company focused on transforming the diagnosis and treatment of male reproductive issues. Based in Belfast, Northern Ireland, Examen was founded by Professor Sheena Lewis, PhD, FRSB. The company started as a spin out from Queens University in Belfast. Examen was set up in response to public demand for its Exact® sperm DNA test.
Cold Chain Ensures Sample Quality
When Examen chose Thermo Scientific™ SampleManager LIMS™ software to improve its operational efficiency, the company was also seeking a better way to manage its liquid nitrogen containers. These containers are a critical component of the Examen testing process, keeping the samples cold during their transfer to the lab.
Examen has 34 liquid nitrogen dry vapor shipping canisters used to collect samples from fertility clinics and hubs around the world. The canisters are pre-charged with liquid nitrogen before they leave the lab, and will maintain a cryogenic temperature of -196 degrees for about two weeks. This provides enough time to transport the canister to a clinic, load the samples for testing, and then return the samples to the lab without breaking the cold chain. Examen handles samples to measure sperm DNA damage to help predict the likelihood of conception, miscarriage and the success of fertility treatment. If the integrity of the samples is compromised during transit then the DNA will degrade and the sample cannot be tested, so preserving the cold chain during transit is vital.
One of the main requirements of Examen’s SampleManager LIMS software implementation was to incorporate tracking and the management of the liquid nitrogen charging process into the system. Before implementing the LIMS, the laboratory relied on pen-and-paper logs to track the calibration. While the manual process worked, Examen sought a more automated process to handle its increasing sample volume and reduce the risk of error.
Cold Chain Goes Digital
Using the built-in Instrument Calibration and Maintenance System (ICMS) in SampleManager LIMS software, Examen can now digitally manage canister calibration and maintenance. To accomplish this, the implementation team added the 34 canisters as instruments in the system. The canisters are then assigned locations to indicate whether they are in the lab or in transit. Viewing a specific location in SampleManager LIMS software provides a quick view of the canisters available at that location.
Further, the canisters are color-coded on the dashboard based on their “Calibration Status.” Green means that the canister has been recently charged with liquid nitrogen and is available for use. Red means that the canister has not been calibrated within the last 2 days and is unavailable for use. This color-coding helps the techs identify the best canisters to ship to a clinic.
SampleManager LIMS software also captures each of the canister calibration events under the “Events” tab for each canister. This provides a complete history of when each canister was calibrated, which staff member performed the calibration, and captures any comments that the staff member entered at the time.
Using SampleManager LIMS software, Examen now has an electronic record connecting all the canisters’ shipping details with the records of the samples that were transported. The system also provides the ability to track when the canisters were last charged with liquid nitrogen (down to the second), and by which member of staff. This helps ensure that staff only select the canisters that are fully charged and ready to be shipped. The laboratory’s manual canister management process is now obsolete, with SampleManager LIMS software providing improved management of this crucial element of the testing process.
To learn more about Thermo Fisher Scientific cold storage solutions for sensitive samples, visit our website. You can also visit our SampleManager LIMS software website for more information on our digital solutions to your laboratory challenges.