Temperature Monitoring Buyer's Guide

David McCormick,

Robust Temperature Monitoring is Essential

Clinical laboratorians are well aware of the essential nature of temperature-controlled environments to modern medical diagnostics. Driven by the need to ensure the integrity of testing systems and reagents, and to protect inherently valuable patient samples and products, the means by which the lab maintains and monitors temperatures throughout the work environment is dictated by the greater institution, as well as by regulatory bodies governing lab practices.

The scope of temperature management is site and work dependent, but the concept of whole-environment monitoring should include the establishment of constant temperatures within refrigerators and freezers (and mitigation of temperature fluctuations), as well as system abilities for monitoring the ambient temperature of storage areas (for supplies and reagents) and testing areas (per equipment specifications for operating temperature and humidity ranges).

Given the essential nature of temperature control, it is wise to remain at the forefront of technology innovation. Digital displays, communications, and storage mechanisms have largely replaced traditional systems that employ less sophisticated mechanics. Myriad alerting functions, detailed user controls, robust data generation and reporting, and sound temperature control are just a few of the features offered by today’s system vendors.

Looking forward, system software refinements will allow preprogramed tolerances for short term fluctuations caused by the opening and closing of doors that do not otherwise affect the integrity of the contents. Allowing for the highly sensitive nature of modern probes, alarm fatigue remains an issue, so ongoing vigilance and preparation for emergencies remains important. As the dependence on electronic devices for almost every activity in the lab only increases, a thoughtful understanding of what effects a downtime scenario would have and what back-up mechanisms are in place is invaluable. Current temperature monitoring systems provide robust, cost-effective, and secure methods for the surveillance and documentation of temperatures. These in turn provide peace of mind regarding product and testing integrity.


David McCormick is the managing editor of Medical Lab Management. He can be reached at davidm@ridgewoodmedia.com


Safe-T-Vue temperature indicators from Temptime provide nonreversible temperature indication for blood products, plasma, and RBCs. Safe-T-Vue temperature-sensitive indicators easily adhere directly to blood bags during refrigeration, transport, and temporary storage. They are ideally suited for use by blood banks, blood collection centers, and transfusion services to maintain quality control in transport and storage of blood products. Available in 6°C and 10°C indication temperatures, Safe-T-Vue changes color from white to red when the indication temperature has been reached or exceeded. Because it is nonreversible, Safe-T-Vue will indicate that a high temperature condition existed, even if the temperature returns to a lower level. Using temperature indicators has been proven to enhance compliance and preserve valuable blood supplies. Easy-to-follow videos for use and validation are provided on the company’s website, as are customizable validation documents. Free samples of Safe-T-Vue can be requested at www.williamlabs.com

Temptime
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Control Company introduces the newest components of their cloud-based laboratory wireless monitoring system—combination temperature/RH monitoring and -90°C temperature monitoring—to the existing TraceableLIVE portfolio of wireless temperature monitors. These devices use the robust TraceableLIVE cloud-based monitoring service, an easy and cost-effective way to access data through iOS, Android, and Web interfaces, and provide alert notifications via email, mobile-push, and text notifications. Setup is simple and can be easily completed to achieve compliance; a WiFi connection is all that is needed. All devices are serialized, calibrated, and certified traceable to NIST under the ISO 17025 accredited calibration process, out of the box.

Control Company
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Onset offers the InTemp CX400 Series Temperature-Controlled Storage Monitoring and Compliance solution. The InTemp CX400 Series is a family of high-performance data loggers for monitoring temperatures in refrigerators, freezers, and other temperature-controlled environments. InTemp CX400 series loggers feature a large LCD display to easily keep tabs on current and ongoing minimum and maximum temperatures throughout the day. Everything is displayed at once, so there is no need to toggle through a series of screens. The LCD also displays when daily temperature checks are done, a visual alarm indicator if an excursion occurs, and ambient temperature readings. Because InTemp loggers require very little power to operate, they can monitor temperatures for up to a year without changing the batteries (two AAA batteries). Battery power also reduces the risk of temperature data loss during power outages. InTemp CX400 loggers come with a second, built-in temperature sensor to track ambient temperatures, thereby eliminating the need for a separate room temperature logger.

Onset
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Lab Sensor Solutions provides an automated, real-time, wireless, cloud-based unified monitoring platform for tracking temperature and location of laboratory materials. The system monitors continuously and alerts whenever an excursion event occurs (based on customizable parameters). The system is administered remotely through a secure Web interface, including sensor configurations and alert conditions and distribution (email, SMS, etc), remedial actions, notations, and historical reporting. In-transit reporting includes automated pick-up and delivery confirmations. There are no infrastructure requirements; no hardware, software, or wiring to install; and no local configurations, portability limitations, or on-site calibration requirements to manage. Sensors feature NIST-traceable certification for up to +/- 0.5°C accuracy, on-sensor data cache; battery life of greater than 1 year; and highly accurate GPS and interior room level location. Applications include: refrigeration, freezer and incubation systems, walk-in units (multi-sensors for monitoring zones), controlled room temperature environments, plus real-time, in-transit monitoring with multi-use and single-use sensors available.

Lab Sensor Solutions
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SMART Temps specializes in temperature monitoring solutions to improve laboratory compliance, loss prevention, and patient safety. Partners with over 14,000 locations nationwide, SMART Temps provides an automated temperature monitoring solution that logs temperatures and relative humidity 24/7, and alerts via text, email, and/or phone call during any temperature excursion or power outage. The reporting tool is completely Web-based, allowing real time remote access from anywhere via Ethernet, WiFi, or cellular networks. All products provide real time temperature documentation that exceeds Joint Commission, CDC, CMS, FDA, and HACCP reporting compliance standards. SMART Temps offers a free 30-day trial.

SMART Temps
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Custom Biogenic Systems releases VersAlert, a wireless monitoring system offering premium features such as calling lists, alarm acknowledgements, text messaging, emails, reporting, and 21 CFR Part 11, at no extra cost. Custom Biogenic Systems has invested in the latest wireless mesh technology providing a range that exceeds traditional systems. VersAlert generates its own private and secure wireless network, and does not use your existing WiFi. Intelligent features, such as the ability to dynamically select the cleanest channel and the ability to self-diagnose and repair make the system suitable for the harshest environments. The VersAlert system features wireless sensors capable of measuring temperatures between -200°C and 50°C, switch closure, and 0-5V or 4-20mA inputs (for humidity, C02, etc). Each sensor can be configured to report at specific intervals, alarm at established set points, and notify particular individuals by email, phone, or text message. The sensors store data in the event of a power outage and report that data upon reconnection. The sensors also report their signal strength, simplifying installation. Up to 300 sensors can be supported through one IP address.

Custom Biogenic Systems
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The DataTrace data logging system from Mesa Labs helps simplify the thermal validation process. DataTrace provides real-time wireless readings for temperature, humidity, and pressure, is compliant with 21 CFR Part 11, and ensures chain of accountability in any space. Temperature loggers have a temperature accuracy of ±0.1°C; humidity loggers have an RH accuracy of ± 2% RH; and pressure loggers have a pressure accuracy of ±0.45 PSIA. The DataTrace system simplifies the validation process by creating automatic reports, sending alarm notifications when readings go above or below established thresholds, and identifying any failure points.

Mesa Labs
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PDC Healthcare offers Timestrip Blood Temp 10, a convenient temperature indicator used to enhance the quality control process for blood transportation. The device monitors the temperature of a blood unit and clearly indicates when a temperature of 10°C has been breached. Timestrip Blood Temp 10 is an easy option thanks to its unique design, which is simple to activate and does not need pre-conditioning prior to use. It also does not need to be refrigerated or cycled. Blood Temp 10 features a push-button activation and the display is clear and easy to interpret. The device helps ensure regulatory compliance with AABB Standards for blood banks and transfusion services, and the FDA’s CFR 600.15(a) for monitoring temperature of whole blood during transportation.

PDC Healthcare
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Memory-Loc Datalogging Thermometer from Health Care Logistics features 2 probe bottles. The thermometer can log up to 2 years of data in one-minute logging intervals. The digital display indicates high, low, and current temperatures in a range from -58°F to 158°F (-50°C to 70°C) and an accuracy of ±0.25°C across the entire temperature range. No software is needed for data retrieval and the units can remain in use while downloading and analyzing data. Status indicators show low battery, memory full, USB data transfer, and active alarm state. Recorded data (CSV file) can be transferred from thermometer to PC or Mac using a USB flash drive (not included). Each thermometer has a unique ID allowing multiple units to be used in the same location. Units store up to 10 unique alarm events and an alarm tracking feature stores each alarm event, detailing when the alarm state occurred and when the unit returned to within range. Alarm state indicators include visual LEDs, audio alerts, and flashing LCD segments. The system is NIST traceable and to assure accuracy, an individually serial-numbered Traceable Certificate is provided with each thermometer. Two AAA batteries are also included.

Health Care Logistics
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Kooltrak Temperature Loggers from Factronics USA are housed in waterproof stainless steel and, hardly larger than a dime, they contains a complete recording system with microcomputer, memory, communications circuitry, temperature sensor, clock, and lithium battery power supply. The wide temperature range, long recording time, and 10-year life make this product an excellent choice for compact, low cost temperature recording. Kooltrak temperature loggers can be used as stand-alone loggers in packages, secondary containers, and pallets to monitor temperature. With a recording temperature range of -40°F to 185°F, the loggers cover sample transport requirements. Comprehensive, user-friendly software supplies ready-made solutions to most problems. Temperature data reports can be handled locally, across a network, or over the Internet.

Kooltrak
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Hampshire Controls Corp’s Alert Monitoring System (AMS) is a PC-based system for continuous monitoring and data recording of environmental conditions. The system has local alarms and email alarm notifications when connected to the user’s network. The AMS can connect to single and multi-probed wired and wireless alarms. Daily and event log reports can be generated easily and emailed. Because the AMS is SQL-based, it can be integrated into an existing computer network for seamless remote data logging, and can be operated in wireless/remote or stand-alone mode. The system features multiple user access capability and wireless network integration.

Hampshire Controls Corp
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Mesa’s ViewPoint Continuous Monitoring Software (CMS) incorporates innovative design with user-friendly features for continuous monitoring. Wi-Fi, wired, or wireless system versatility makes ViewPoint an ideal option for clinical laboratory applications. The interface offers views of all assets on one or several floor plans with visual asset representation, as well as the ability to view inputs in a tile or list view. The software can be used remotely and offers the ability to import floor plan maps and overlay assets to their locations with an easy-to-use drag and drop function. Filters may be utilized to quickly view alarming assets or inputs specific to groups of assets. VPx Sensors integrate seamlessly with Mesa’s ViewPoint Web-browser user interface, providing access from any computer or networked mobile device (off-network capabilities also available). The sensors can monitor several different parameters, for various applications, with an optional LCD display. ViewPoint’s VPx sensors offer extended battery life, line-powered options, and local alarming and muting.

Mesa Labs
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The Val-A-Sure Cooler Validation Kit from Temptime combines everything needed for blood transport cooler validations in one simple kit. Temperature assurance is crucial for the safe transport of blood and blood products, and validation of transport containers can be a frustrating and often confusing task for facilities of all sizes. Val-A-Sure combines all of the necessary components, instructions, and documentation for validation in a kit, and these components have been tested to work together efficiently and accurately. It delivers the simplicity, accuracy, standardization, and speed of process that blood banks and labs require in one kit that incudes electronic dataloggers, temperature probes, validation SOPs, video instructions, datalogger software, and an instructional video. Val-A-Sure can help ensure consistent measurement and recording of each validation, and can be used for other temperature validations in the lab.

Temptime
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The Multi-Probe Alarm System (MPS) from Hampshire Controls Corp monitors, alarms, and notifies the laboratory based on programmed condition data. It includes a system relay or relay output per probe, battery backup, minimum/maximum conditions, email alarm notification (when connected to the user’s network), and can connect to the alert monitoring system. The system is ideal for monitoring products stored in refrigerators and freezers.

Hampshire Controls Corp
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The Isensix Guardian Monitoring Solution can seamlessly monitor all devices, enterprise-wide, across buildings and remote locations, with no limit to the number of devices. Guardian sensors provide local audible and visual alarming at the appliance, as well as documentation of event, personnel, and corrective action at the point of occurrence, with no need to go to a computer to close and document an event. Isensix helps reduce operating costs, enhance efficiency, and ensure the highest level of quality assurance. Guardian hardware supports sensor types to monitor virtually any piece of equipment in the laboratory, encompassing temperature, humidity, oxygen, carbon dioxide, and differential pressure. Guardian software delivers real-time alerts, multiple reporting formats, and notifications by phone, text, email, or pager. Isensix Support provides hotline support and assistance for system maintenance, including monitoring system uptime and the health of the Guardian infrastructure to insure seamless and continuous operation. With more than 30,000 users, Isensix has the experience to safeguard temperature sensitive laboratory products.

Isensix
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TempTrak 900 MHz transmitters from Cooper-Atkins pass information wirelessly to the TempTrak application, which collects and records data 24/7. The transmitters operate on a 900 MHz frequency-hopping spread spectrum with an open-field range of up to 2,500 feet and a typical interior range of up to 500 feet. Each transmitter is battery operated and monitors against preset conditions that are user-defined within the TempTrak application. Battery operated, the 900 MHz system is capable of collecting, storing, and transmitting data wirelessly for up to 400 hours (16 days). Information recorded to the database (°F/°C) is time stamped and cannot be altered through the user interface. This 900 MHz TempTrak transmitter contains temperature and humidity sensors. The temperature sensor range is 4°F to 140°F (20°C to 60°C) and the humidity sensor can monitor 0% to 95% RH (non-condensing).

Cooper Atkins
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Elpro ECOLOG-NET wireless and wired monitoring solutions for rooms and equipment are Swiss-engineered, scalable systems offering multiple alarm notification options and levels, in addition to continuous monitoring and redundant data storage. Providing simple and seamless integration into existing LAN, annual on-site calibration service is provided, including NIST-traceable certificate. The system is compliant with FDA 21 CFR Part 11, GLP, GMP, The Joint Commission, AABB, and USP guidelines for monitoring. Developed per the V-model and GAMP5 validated, the system is offered with elproLOG MONITOR-WebAccess, a real-time, Web-based monitoring platform. Ideal for monitoring lab equipment, warehouses, rooms, and cleanrooms, ELPRO offers efficiency and compliance solutions throughout the entire supply chain. Thermal facility and equipment mapping services also are available.

Elpro
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VersaTrak wireless temperature monitoring system from the Veracity Group offers both 900 MHz and WiFi transmitter solutions, as well as a large selection of probes for every laboratory application. The system allows monitoring of refrigerators, freezers, room temperature and humidity, differential pressure, real time particle count and more. VersaTrak is a second-generation software created specifically for the compliance needs of the health care industry. VersaTrak also created and patented Auto Node Calibration (ANC), the only self-calibrating transmitter on the market.

Veracity Group
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