February 15, 2022
Everything You Need to Know about Laboratory Temperature Monitoring
For laboratories, temperature monitoring can be a dense, complex topic. It can be challenging to determine what type of monitoring system is right for your team. What resources will you need to maintain and use these tools effectively?
With this guide, you can cut through the jargon and get answers. Productive temperature monitoring is critical to running a successful lab. Read on to discover how your lab can surveil, track, and respond to temperature data in line with best practices.
Why is Laboratory Temperature Monitoring Critical?
Temperature monitoring is a mandatory practice in laboratories. When it’s done well, labs see improvement in five areas. The need to serve these functions drives the development of new temperature monitoring technologies.
Safety is the most important effect of laboratory and pharmacy temperature monitoring. Temperature-sensitive drugs can become contaminated, ineffective, or even poisonous if they’re out of a controlled environment for too long. Monitoring ensures proper storage and enables staff to dispose of medications or compounds that have developed risks.
Laboratories that conduct research or manufacture products need to have replicable results. All products must be standardized and uniform. If a compound is erroneously left in an environment outside of the standard temperature, and nobody notices, staff may record inaccurate data.
As inaccurate data moves downstream, analyses of that data will be faulty. This ultimately harms the efficacy of drug and chemical research.
Accuracy is a similarly critical effect of temperature monitoring systems. Brief fluctuations in temperature may go unnoticed. Thus, the effects of those fluctuations will not be accounted for.
Laboratory temperature monitoring systems are cost-effective. The system will alert staff of a temperature fluctuation where drugs and compounds are stored. This enables staff to intervene and protect climate-controlled substances before the temperature exceeds a safe threshold.
Without quick intervention, all overheated products must be disposed of. Preventing this loss is incredibly cost-effective. In 2019, losses due to cold storage failures totaled $35 billion worldwide.
It’s vital to abide by federal and international regulations. An accurate temperature monitoring system empowers laboratories to avoid accidental non-compliance. Regulatory guidelines are established by scientific consensus.
Laboratory Temperature Guidelines and Mandates
Regarding legality, explore the temperature regulation mandates from the following organizations. Some are government departments. Others are professional or official research organizations.
World Health Organization
The World Health Organization (WHO) publishes guidelines on temperature mapping of cold-storage areas. This is the most recent publication. WHO officials update the guidelines as new data comes to light that can inform best practices.
WHO also researches laboratory quality standards and implementation. The organization periodically publishes the results of that research—including potential applications. You can examine the regulatory body’s latest document on the subject.
Centers for Disease Control
The Centers for Disease Control (CDC) imposes mandates to mitigate the risk of illness or injury. It publishes laboratory procedural manuals on handling specific drugs and diseases.
For example, this publication details how to safely handle HIV-1 RNA. These manuals are useful for any lab working with cold-sensitive medications.
Food and Drug Administration
The Food and Drug Administration (FDA) strictly regulates medical substances, devices, and practices. Laboratories that handle drugs or medical equipment must abide by all FDA guidelines.
The regulatory body routinely publishes information updating medical safety mandates. Temperature monitoring systems enable labs to meet FDA standards. In particular, accurate temperature information is relevant to standards concerning drugs and medical devices that require refrigeration.
The FDA published a clarifying document on Good Laboratory Practices (GLP), including temperature monitoring. The publication clarifies common concerns about its laboratory regulations.
College of American Pathologists
The College of American Pathologists is an advocacy group comprised of board-certified pathologists and patients. It conducts research and advocates for excellence in the field.
CAP grants peer-based accreditation to laboratories that meet its standards. Many of the organization’s guidelines include temperature range requirements. Temperature monitoring systems make it possible for laboratories to meet those requirements.
Association for the Advancement of Blood and Biotherapies
The Association for the Advancement of Blood and Biotherapies (AABB) is a professional medical accrediting organization. AABB’s quality system framework incorporates internationally recognized best practices with new developments.
Its standards are thorough, and each standard pertains to a specific drug, medical device, tool, or process. Temperature monitoring systems enable laboratories to meet a range of AABB’s temperature-oriented standards.
Occupational Safety and Health
Laboratories working with cold-stored substances must abide by OSHA’s cryogenic regulations. This enables laboratories to maintain a tightly controlled temperature without risking cold burns. Temperature monitoring systems can alert staff of dips in temperature that elevate the risk of cold abrasion.
OSHA does not directly set drug handling regulations. It is an office of the Department of Health and Human Services. It sets standards for employers to ensure protections for workers.
These standards impact temperature-controlled laboratories. OSHA requires laboratories to record cold-substance handling procedures in a chemical hygiene plan (CHP). Developing and implementing this plan is in line with best practices.
Temperature Monitoring Best Practices
Laboratories reap benefits when they implement best practices. When it comes to temperature monitoring, best practices fall into one of nine categories.
Consider evaluating your laboratory’s current practices systemically with this rubric. Assessment can help you identify your organization’s weak points, then target them for reinforcement.
Precise Instrument Calibration
Instrument calibration is critical. It sets equipment up correctly, so each part will convey accurate data. Measurement tools lose their accuracy over time. Laboratories must schedule routine calibration to reset instruments, tuning them to a standard of known accuracy.
Calibration specialists learn the standards of accuracy relevant to each tool. It’s often cost-effective to outsource calibration to a specialist. This save’s laboratory staff time for different tasks.
It is possible to mitigate certain environmental factors that impact calibration. Airflow, pressure, and elemental degradation can all affect a metric tool’s accuracy. Laboratories often take steps to minimize changes in pressure and elemental exposure, including:
- Implementing automated doors
- Adhering to a routine cleaning schedule (including gasket maintenance)
- Choosing high-adhesion gaskets
- Preventing fridge over-stuffing
These choices make it easier to maintain a desirable temperature in a refrigerated space.
Temperature monitoring is most accurate when the monitored space is contained. The best containment units, like refrigerators, use latches and seals to minimize the effect of external forces on the cold-controlled environment. Medical-grade refrigerators often incorporate seals made from:
- PORON foam
- Medical-grade silicones (per FDA Part 21 CFR 177.2600)
- Other synthetic materials
Seals keep out contaminants like dirt and EMI which may alter the refrigerator’s interior temperature. Refrigerators may require two keys to unlock manually.
Alerts, Alarms, and Responses
A temperature monitoring system’s alarms and alerts should be directed to specific staff. Created alarms that alert staff trained to respond to alarms correctly. Consider the best alarm methods to signal the right staff member.
Many temperature monitoring systems also track pressure, humidity, and air quality. These systems’ alarms can likewise alert staff regarding dangerous shifts in these numbers.
It should be easy to read the monitoring system’s data at a glance. Choose a system with a digital face. Consider the user interface aspects that help or hinder readability.
Temperature monitoring systems continually report data. But, not all systems automatically log that data. Automated data logging is a useful asset for all laboratories.
Automated data logging reduces the risk of human error. When staff must input temperature data regularly, they may misremember it, or type it incorrectly.
Automated data logging also enables more frequent data collection. Staff does not have to stop amid other tasks to log the data. Instead, they can focus on other work, while the device records data at frequent intervals.
Data Storage, Communication
There are barriers to effectively storing and communicating temperature data. Fortunately, there are established tools to surmount those barriers. Research your options regarding:
- Data compression
- Wireless transmission
- Automated data management
WHO requires laboratories to maintain a log of temperature data for the shelf life of any product, plus one year.
Redundancy and Failsafes
Laboratories face the risk of power outages, fires, and natural disasters. To mitigate these risks, the best temperature monitoring systems incorporate failsafe and redundancies.
The most critical failsafe is backup power. Coordinate with a hospital or purchase your own backup generator. Make sure refrigerators holding delicate specimens have at least one plug plugged into emergency power outlets at all times.
Supply chain shortages can create barriers for laboratories. Build in supply redundancies by ordering duplicate tools, like probes. Laboratories can also share tools with other cold-storage groups. This horizontal integration strategy can save money, but it risks a situation where no local laboratory has the short supplies.
Remote Temperature Monitoring
Some of your laboratory’s drugs and substances need to be kept cold in transit. Practicing remote temperature monitoring empowers you to observe and intervene in temperature spikes in your refrigeration units, even when they’re en route to their destination.
Remote temperature monitoring uses RFID tracking to observe unit temperatures and locations from afar. RTM systems typically build in seamless communication. That way, you can contact support staff nearby to intervene when cooling systems fail.
Best Laboratory Temperature Monitoring Tools, Systems
Laboratories do their best work when they have the best tools. When it comes to temperature monitoring, the best tools integrate into intuitive, sophisticated, and resilient systems.
Most systems are composed of six distinct parts. It’s wise to evaluate each option per part. Anchor your evaluation in how the part’s traits may best serve its function.
Key Laboratory Monitoring Tools, Options
There are a variety of options on the market for each of the six parts of a temperature monitoring system. Which option works best for your lab depends on the nature of your work, your environment, and your budget. Different materials are better suited to different types of temperature monitoring work.
Probes and Sensors
Temperature probes and sensors detect the current temperature of a solid object, gas, or liquid. Probes are sensitive to minute temperature fluctuations, which mercury thermometers do not pick up on. There are three probe options:
Probes are sophisticated tools. Research your options to choose the right ones for the job at hand.
Thermal buffers hold the probe or sensor. Buffers regulate inevitable, brief, abrupt temperature fluctuations.
Fluctuations happen during routine lab use. For example, when a technician opens the refrigerator door, that shifts the internal temperature.
A buffer prevents a false reading from these brief events. It simulates the experience of the stored product, not the surrounding environment as a whole. Thermal buffer options include:
- Ethylene glycol bottle
- Glass bead bottle
- Nylon block
Liquid blocks best mimic liquid substances.
Temperature Measurement Recording Devices
Measurement recording devices regularly log temperature data. Often, these devices also routinely transmit or store that data. They may store data locally, or transmit data wirelessly.
Data Storage Options
Data storage is a piece of computer hardware that holds the log of temperature data and includes:
- Internal memory
- Base station or gateway
- Local PC
- Data storage cloud
Internal memory and local PC data storage are the most secure. Data storage clouds and gateways to external storage offer you more space.
The software receives data transmitted by the probe and measurement device. Then, it helps laboratory technicians and others use that data. Typical temperature monitoring software functions include:
- Data retrieval
- Alarm management, settings
Choose multifunctional software with a polished interface.
Alerts and Alarms
Alerts and alarms tell staff when a substance’s temperature is dangerously high or low. There are five types of alarms:
Many laboratories choose to implement multiple alarm options.
Implementing Effective Temperature Monitoring Processes
It’s good practice to implement an effective temperature monitoring procedure. Part of that is establishing a routine temperature review schedule. Following that, analyze the data for trends that may signal some dysfunction.
Ideally, laboratories will also engage in temperature mapping validation. Temperature mapping validation is a functionality assessment of the equipment in your laboratory. A series of tests determine if refrigeration equipment and monitoring tools perform as they ought to in theory.
Finally, you’ll want to establish a triggered temperature review protocol. This is a response to an alarm that indicates a pattern of temperature fluctuation. The review determines the source of the fluctuation.
Master Temperature Monitoring With SensoScientific
Every year, temperature monitoring systems evolve. Your laboratory can stay up-to-date with SensoScientific. Get accurate, precise data when you need it with premium monitoring equipment.
No matter what equipment you use, SensoScientific can provide onsite expert calibration services. And, our temperature monitoring systems come with whole-team training and full-time technical support. Contact us today for a free consultation.