As clinical trial sites move to distant geographic areas and more biologics are involved, temperature monitoring of drug shipments becomes a growing need. Almac has responded with a system it believes will transform temperature monitoring for clinical trials.
Demand for temperature-controlled storage and distribution has increased steadily over the past few years, primarily as a result of the increased use of biologics. As a direct result of this demand from customers, Almac recently increased its 2–8°C storage capacity by 400% with the opening of a 271,000ft3 facility at its North American headquarters.
The need for temperature control and monitoring does not end with the storage of products. To ensure the quality of protein-based compounds, accurate temperature monitoring throughout the distribution cycle is a must. Rapid access to temperature data from these shipments is essential for cost and time savings. As the use of biologics continues to grow, as is commonly projected, the need for temperature-controlled services and easy access to shipment temperature data will also grow.
Almac marked the start of 2010 with the launch of a new, web-based Shipping Temperature Electronic Monitoring System – STEMS – to improve management of temperature-controlled shipments within the clinical trial industry.
Temperature excursions can inhibit the clinical supply chain, resulting in crucial investigational products being delayed or quarantined and not available for those in need at the study site. Excursions can occur at any point in a global supply chain and often arise as a result of multiple uncontrollable factors.
Currently, out-of specification shipments are not recognised until they are received by clinical trial sites, shipping boxes opened and temperature monitors examined. This is often time critical. For example, if the medication delivery is just-in-time, a patient dose may be missed while the site awaits a re-supply shipment or confirmation of whether the medication is usable.
Using STEMS, clinical supply professionals will have immediate visibility upon monitor upload to each of their crucial shipment temperature reports. This enables users to make instant decisions 24/7 on their clinical supplies without the need for monitor returns or faxing of results.
STEMS comprises a combination of proprietary and partner technologies validated and fully-compliant with 21 CFR Part 11 requirements. The system also integrates fully with an Elpro Libero PDF data logger, a single device used for temperature monitoring during the global transfer of goods that requires no specific software.
how it works
STEMS compiles the Almac shipment details, including the shipping reference and tracking numbers, and pre-defined trial-specific details, including on-screen instructions for consignees and the list of recipients for e-mail notifications. It then uses the Elpro Libero Configuration Utility and Libero SmartStart technology to apply custom, multi-zone temperature parameters to the Libero monitor. This links the temperature monitor details with the shipment details, without the need for cross-referencing between different information sources.
The company is actively working with other providers of USB-enabled temperature monitoring devices to achieve a similar automated integration of shipment and temperature data.
The Elpro Libero PDF data logger automatically generates a secure PDF/A file containing the temperature data for the shipment. No additional software is required to view the temperature data, nore are additional devices or cables required to access the temperature report. The device simply plugs into a USB port, making it easy and convenient for the shipment recipient.
The multiple alarm zone capability of the Libero allows the alarm settings to be customised to match the product stability data, thus greatly reducing the occurrence of false positives. Here again, the company is working with other solutions in the marketplace to provide the best possible access and coverage of the STEMS system.
This technology allows Almac’s warehouse technicians to access the STEMS system during shipment processing. They select the appropriate temperature settings for the material being shipped, and, when prompted, insert a blank (un-configured) Libero monitor into the computer’s USB port. STEMS then applies the product-specific temperature settings to the device. Once configured, the monitor is removed from the USB port, started and placed in the shipping unit.
on-line access
STEMS is best suited to trials where real-time notifications of shipment results and immediate on-line access to temperature data are essential to the management of the drug supply. On-line data access and decision-making by global project teams is key for reducing quarantine time for trials where the time from shipment receipt to dispensation to patient is limited.
When the shipment arrives at its destination, the recipient removes the monitor from the shipping unit and stops the device. Using any web browser and high speed internet connection, the recipient navigates to the STEMS upload website and enters the serial number of the temperature monitor. A series of on-screen instructions guide the recipient on how to proceed.
The monitor is plugged into a USB port; the PDF temperature data file is selected and then saved into STEMS.
Additional on-screen instructions are then displayed to the site to provide guidance on the next actions required, i.e. quarantine the material in the event of a temperature excursion, or proceed to use material in the event the monitor did not alarm.
When the upload is complete, STEMS sends real-time e-mail notifications to a pre-defined list of recipients. These notifications include temperature summary details and a clear indication as to whether the shipment remained within the allowable temperature limits. For shipments where a monitor alarmed (shipment temperature went out of the allowable range), a link is provided to allow nominated decision-makers to access the complete temperature data report and record decisions on the disposition of the affected material.
Very little training and no technical expertise is required to use the STEMS system. With each shipment, an upload instruction card is included to give the recipient step-by-step pictures and instructions on the actions required to upload the temperature data. In advance of the trial, a click-by-click guide to uploading the temperature monitor reports is available to customers, for inclusion with other training material being compiled for each trial. A click-by-click guide for persons responsible for reviewing temperature data is also provided. Training by webinar or on-site is also available.
This system employs single-use temperature monitors. Once the temperature report has been uploaded into STEMS, the device is no longer required and can be disposed of in a responsible manner. This means there are significant cost reductions in courier fees (as the monitors do not have to be returned), data review (from the reduction in false alarms) and study start-up supplies (monitors are configured with product-specific temperature ranges at the point of distribution, eliminating the need for large amounts of pre-programmed product-specific inventory).
The system is ideal for trials where archiving and retention of temperature data is critical for future regulatory submissions. Trials conducted in countries where the return of temperature monitoring devices is a convoluted or lengthy process will benefit from the direct monitor report upload. Recipients can upload the temperature data without the need to return the device.
Having talked about its advantages, it is worth noting that the STEMS website is best accessed with a high-speed internet connection. Furthermore, the website is available only in the English language. However, from experience with other English-only web-based service offerings in more than 40 countries, Almac has not found the language to be a barrier.
STEMS is set up in conjunction with other general distribution set-up activities, thus adding minimal time to the overall trial start-up process. It can even be added to trials where distribution is already ongoing. Easing into STEMS with a small pilot trial, or committing straightaway with a large multi-country trial is entirely up to the customer – the system has been utilised with great success in both scenarios, says the company.
support levels
Technical support for the system is offered in the form of a general questions 24/7 hotline with toll-free local phone numbers for more than 45 countries, as well as offering trouble-shootng for technical errors. A translation service is also available and a listing of the country-specific phone numbers is available from any page within STEMS, as is a link to e-mail the technical support staff with questions or to report errors.
material savings
By allowing instant on-line review of temperature data, quarantine time is near zero for shipments experiencing a temperature excursion. This reduces the need for emergency shipments of product designed to replace the material that has been quarantined pending temperature data review.
Multiple alarm zone settings also reduce the number of false alarms and, in turn, the needless destruction of material where a temperature monitor is alarmed but the material did not exceed the stability parameters.
Response to STEMS has been very positive, particularly in Europe where transit times can be long and monitor return is potentially difficult. Time saved from waiting for temperature reports and needlessly reviewing false alarms, and no courier fees for the return of devices is already translating into significant cost savings.
As biologics continue to grow and move out of the clinical trial phase and into approved use, there will be a clear role for systems such as STEMS in managing temperature data for commercial supplies in future.
