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  • NYC Hospital Examines WTM Options

    Wireless Temperature Monitoring systems can vary greatly in design, technology, ease of use.

    This third piece of the series examining New York Hospital Queens’ experience with Wireless Temperature Monitoring systems as reported on the Pharmacy Purchasing and Products website article, we look at the options considered and some that were not . (Link to PPP Article)

    Once medication, blood and nutrition products refrigeration was evaluated and found lacking prompting a replacement of dorm style units with over 100 medical grade refrigeration in patient care areas, the next step was to examine WTM options for evaluation. According to author Alexander F. Melchert, , MS, RPh, the Director of Pharmacy at the hospital, “Several WTM systems were evaluated culminating in the adoption of one that best suited our needs.

    The hospital selected a device that utilizes wireless sensors connected to probes immersed in a bottle of ethylene glycol as ideal for their needs. The ethylene glycol bottle is used as a buffer to reduce temperature fluctuations that can result in false alerts. (Note: Liquid ethylene glycol and propylene glycol are commonly used in laboratory and food applications, dry sand or glass beads are options that eliminates the potential for liquid spills.) The temperature sensor is immersed into the bottle which is then capped and placed into the refrigerator. Two other factors noted were cost and the ability to self-install, meaning hospital personnel could perform all of the tasks to place the sensors and get them operating correctly, not a small consideration when dealing with new and potentially complicated technology.

    Temperature buffer vial comparison: Air, dry sand, and propylene glycol shows damping effects of each. Damping is useful to manage momentary temperature changes that are not significant to the product’s efficacy, safety or quality. (Link to Source)

    Dry or liquid media filled buffer vial with temperature sensor installed helps reduce temperature fluctuations due to medical refrigerator door opening and the possible triggering of alarms or alerts that do not compromise the medication.(Link to Source)

    The Pharmacy Purchasing and Products article’s author describes other aspect of the experience. “The WTM system was phased in over a one-year period. Once an area was integrated into the electronic process we discontinued the use of manual logs, with the exception of situations where network downtime exceeded 12 hours. In addition, because these refrigerators and freezers are designed for hospital use, they typically include ports or access points for inserting the temperature sensors, easing the installation process.

    WTM devices can take many forms and use many different technologies. The devices may be battery powered, have internal batteries for backup during power outages, or be powered by the sites electrical power. Which type of power one selects is dependent on whether or not the device is required to be operating when the sites electrical power goes down or, in the case of sites with emergency generators, how long the backup power can operate. Sites that require temperature monitoring regardless of external power sources will want to choose WTM systems that can operate on internal batteries for several days if not longer. Such devices will also need internal data logging and downloading for times when network connects are interrupted.

    A second key factor to consider is the wireless communication technology. Several options exist including WiFi, Bluetooth, RFID, ZigBee, WLAN, WiMax, NFC plus mobile communication technologies such as GSM, CDMA and LTE. The choices can be daunting since each wireless technology comes with its strengths and weaknesses. Wireless technology options will be explored in the next piece in this series. The good news is the user need not be an expert on the technology options. One does have to be clear on the requirements or scope of work, and once that happens the best option or options will rise to the top.

    Wireless sensor communication technologies comparing data rate and range (Link to Source)

    Temperature@ert’s WiFi, Cellular and ZPoint product offerings linked to the company’s Sensor Cloud platform provides a cost effective solution for organizations of all sizes. The products and services can help bring a laboratory or medical practice into compliance with minimum training or effort. For information about Temperature@lert’s Cellular and SensorCloud offerings, visit our website at http://www.temperaturealert.com/ or call us at +1-866-524-3540.

    Free Vaccine Monitoring Guide


    Written By:

    Dave Ruede, Well-Versed Wordsmith

    Dave Ruede, a dyed in the wool Connecticut Yankee, has been involved with high tech companies for the past three decades. His background in chemistry and experience in a multitude of industries such as industrial chemicals and systems, pulp and paper, semiconductor fabrication, data centers, and test and assembly facilities informs his work daily. Well-versed in sales, marketing, management, and business development, Dave brings real world experience to Temperature@lert. When not crafting new Temperature@lert projects, Dave enjoys spending time with his young granddaughter, who keeps him grounded to the simple joys in life. Such joys for this wordsmith include reading prize winning fiction and non-fiction. Although a Connecticut Yankee, living for a decade in coastal California’s not too hot, not too cold climate epitomizes Dave’s favorite temperature, 75°F.

    Temperature@lert Dave Ruede

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  • Propylene Glycol: Fast Food Application and Beyond

    Propylene Glycol: What is it?

    Our recent blog post "Buffer Vials for Temperature Monitoring: Propylene Glycol or Sand?" discusses the usability of each substance for a buffer vial. Apart from this particular application, propylene glycol is a common ingredient in a variety of food, cosmetic, and industrial products. It's also continually listed on lists of "Gross Food Ingredients" that can be found in any corner of the web. Still, the question remains, what exactly is propylene glycol, and how common is it in food products?

    The first answer is a bit complicated. The Agency for Toxic Substances and Disease Registry (ATSDR) released a toxicological profile for Propylene Glycol in 1997. This is extracted from Section 1.1

            “Propylene glycol is a synthetic liquid substance  that absorbs water. Propylene glycol is also used to make polyester compounds, and as a base for deicing solutions. Propylene glycol is used by the chemical, food, and  pharmaceutical industries as an antifreeze when leakage might lead to contact  with food. The Food and Drug Administration (FDA) has classified propylene glycol  as an additive that is "generally recognized as safe" for use in food. It is used to  absorb extra water and maintain moisture in certain medicines, cosmetics, or food products. It is a solvent for food colors and flavors, and in the paint and  plastics industries. Propylene glycol is also used to create artificial smoke or fog  used in fire-fighting training and in theatrical productions.”

     

    Where is it?

    With that said, public opinion and some studies studies have shown that (despite rigorous testing and assurance) propylene glycol may have adverse health effects. The Environmental Working Group (EVG) classifies the substance as a “moderate hazard”  due to being “classified as expected to be toxic or harmful” to the Organ system based on Canada’s domestic substances list.  Whatever the case may be, it’s no secret that Propylene Glycol exists in many of the products that we use.

    Shifting the focus to fast food, propylene glycol has long been established as an excellent additive for mass food distribution and storage, and it continues to be used constantly in the fast food industry.  Drawing data from the corporate websites and nutritional information sheets, here is a short (but complete) list of the fast food products that contain propylene glycol. We’ll focus primarily on the “Big 3” (McDonald's, Wendy’s, and Burger King) and all relevant ingredients will be included.

    Wendy’s:

    Heartland Ranch Dipping Sauce:

      Soybean Oil, Water, Distilled White Vinegar, Buttermilk (cultured lowfat milk, milk, nonfat dry milk, salt, sodium citrate, vitamin apalmitate), Corn Syrup, Egg Yolks and Enzyme Modified Egg Yolks, Sugar, Contains 2% or Less of: Salt, Modified Corn Starch, Torula Yeast, Lactic Acid, Phosphoric Acid, Sodium Benzoate and Potassium Sorbate (preservatives), Garlic Powder, Polysorbate 60, Xanthan Gum, Onion Powder, Disodium Inosinate, Disodium Guanylate, Spice, Natural Flavor, Cultured Cream, Parsley (dehydrated), Enzyme Modified Milk, Calcium Disodium EDTA (to protect flavor), Propylene Glycol,Buttermilk Powder, Molasses, Soy Lecithin. CONTAINS: EGG, MILK, SOY.

     

    Burger King:

    Apple Cider Vineagrette Dressing

    Soybean oil, water, high fructose corn syrup, vinegar (balsamic, cider), apple juice concentrate, egg yolk, contains less than 2% of: sugar, natural flavor, salt, xanthum gum, potassium sorbate and calcium disodium EDTA as preservatives, spice, onion, garlic, propylene glycol alginate, citric acid.

    Pickles:

    Cucumbers, Water, Vinegar, Salt, Calcium Chloride or 1/10 of 1% Sodium Benzoate as a preservative, Alum and/orPropylene Glycol, Polysorbate 80, Natural Flavors+, Yellow #5, Turmeric Oleoresin, Blue #1, Soy Lecithin. Natural flavors from plant sources.

     

    BK Stacker Sauce:

    Soybean Oil, Sweet Relish(Cured Cucumbers, High Fructose Corn Syrup, Vinegar, Onion, Salt, Red Bell Peppers, Xanthan Gum, Sodium Benzoate And Potassium Sorbate (Preservatives), Natural Flavorings, Calcium Chloride, Polysorbate 80, Turmeric), Sugar, Water, Distilled Vinegar, Tomato Paste, Egg Yolk. Contains Less Than 2%: Salt, Dehydrated Onion, Xanthan Gum, Sodium Benzoate And Potassium Sorbate As Preservatives, Natural Flavors, Propylene Glycol Alginate, Polysorbate 60, Caramel Color, Oleoresins Paprika And Turmeric (Color), Canola Oil, Calcium Disodium EDTA Added To Protect Flavor. Natural Flavors from plant sources.

     

    Soft Serve Ice Cream:

    Milk fat and Nonfat Milk, Sugar, Sweet Whey, Corn Syrup, High Fructose Corn Syrup, Propylene Glycol Monoesters, Natural and Artificial Vanilla Flavor, Mono & Diglycerides, Guar Gum, Disodium Phosphate, Sodium Citrate, Cellulose Gum, Carrageenan. 

     

     

    Soft Serve/Shake Mix:

    Milk fat and Nonfat Milk, Sugar, Sweet Whey, Corn Syrup, High Fructose Corn Syrup, Propylene Glycol Monoesters, Natural and Artificial Vanilla Flavor, Mono & Diglycerides, Guar Gum, Disodium Phosphate, Sodium Citrate, Cellulose Gum, Carrageenan.

     

    McDonald's:

    1.      Big Mac Sauce

    2.      Buttermilk Ranch Sauce

    3.      Chipotle BBQ Sauce

    4.      Tangy Honey Mustard Sauce

    5.      Cilantro Lime Glaze

    6.      Bagels

    7.      Breakfast Sauce

    8.      Hotcakes

    9.      Oatmeal Raisin Cookie

    10.     Hot Habanero Sauce

     

    In the interest of spacing, McDonald’s products were listed without their entire ingredient list. What can be observed, is that a significant divide exists between the fast food giants on the usage of Propylene Glycol. Wendy’s, according to their own nutritional website, lists only one product (a dipping sauce) that contains Propylene Glycol. 

    Burger King, similar to Wendy’s, lists only one sauce as containing the ingredient in the midst of a handful of sauce variations. Yet, Burger King appears to be using this ingredient in a handful of other products, including the ever-so-necessary pickles (which are included in every Burger Sandwich). 

    McDonald's lists up to 10 products that contain Propylene Glycol, including the famed ‘Big Mac’ sauce. In truth, the scientific applications of the product (that is, why it's in the food to begin with) are well documented and well detailed by the FDA. As stated, Propylene Glycol has a hand in many industries and products, including (taken from Shell's Website) bath tubs, small boats and water/chemical tanks and pipes. Other end use application areas are paints and coatings; aeroplane de-icers/anti-icers; antifreeze and industrial coolants; detergents; hydraulic fluids; and cosmetics. Our blog post also outlined the benefits of a Propylene Glycol-filled buffer vial for use in vaccine refrigeration.

    For more information on Propylene Glycol and usage, visit the DOW index on Propylene Glycol for other industrial and commercial applications.


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  • Storage Control for Vaccines: CDC and Incremental Monitoring

    To continue from previous blog posts, the CDC posts a variety of guidelines related to temperature monitoring, measurement, and best practices that are interconnected with many of our offerings. While these suggestions and comments are useful for general purposes, consult with the official CDC.gov website for the official guidelines.

    The CDC's minimum recommendations for Temperature Readings/Documentation state that temperatures should be logged twice daily, preferable in the morning. Unfortunately, while this gives a nice "bi-daily" snapshot of the storagetemperatures, it fails to account for temperature changes and fluctuations (which may compromise vaccines) in the 12-hour periods wherein readings are not recorded. It's unlikely that any provider would find these minimum guidelines acceptable for a sensitive vaccine, and we agree that this guideline is hardly a 'minimum' at all. As some vaccines have precise and more strict temperature requirements (variability of 6 degrees, for example), incremental monitoring surfaces as the optimal solution. Here's a "short" list of the vaccines that must be stored with a 6 degree temperature range, not including combination vaccines.

    DPaT
    Hepatitius A & B
    HPV
    Influenza (LAIV & TIV)
    IPV (Polio)
    MMR (Measles, Mumps, Rubella)

     

    As for intervals, "CDC recommends the use of a continuous monitoring device/digital data logger to record and store temperature information at frequent programmable intervals for 24-hour temperature monitoring." 

    This sheds light on the importance of incremental monitoring, and the need for "around-the-clock" monitoring. We all understand the importance of temperature (as it relates to vaccine storage), but can we really afford to check temperatures once every 12 hours? CDC might admit that their own minimum requirements are hardly sufficient for vaccine storage of any kind, and their additional suggestions prove that the minimum is hardly relevant for vaccine storage in general. In truth,  a programmable interval should be set for each individual storage unit, as certain units may house vaccines that are more/less sensitive to temperature change (and thereby, require less supervision than others). 

    Along with incremental monitoring, the CDC also recommends the use of buffer vials, specifically stating that "The digital data logger should be connected to a detachable thermometer probe encased in a biosafe glycol-filled vial. The data logger's active digital display should be attached to the outside of the storage unit to allow reading temperatures without opening the door".

    We've talked about the difference between glycol and sand buffer vials in a previous blog post, viewable here. With either choice, buffer vials are another important piece of the monitoring puzzle. 

    Finally, you may be wondering, "what exactly is incremental monitoring" or "what are the programmable intervals that I should be setting for my temperature readings?" The CDC recommends 15 minute monitoring, or 4 logs per hour, for proper supervision of storage temperatures. Their minimum requirements are set at a far distance from this suggestion, and the truth is that it depends on the vaccine being stored. Make sure to have a complete emergency plan in preparation for temperature monitoring failures, whether the cause is human, mechanical, or a simple power outage. Many temperature monitoring devices (including our own Cellular edition) are specifically designed for fail-safe operation, and with correct use of incremental monitoring, you may detect a potential temperature problem before it develops into a disaster. 



    For more information on CDC guidelines, view the comprehensive "Vaccine Storage and Handling Toolkit". 

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  • FSIS Appliance Monitoring: Ovens, Microwaves, and Freezers

    The Food Safety and Inspection Service (FSIS), an arm of the United States Department of Agriculture (USDA) has maintained 'best practices' for measuring temperature in different refrigerated/heated environments. These tests will tell you if your equipment is in correct working order. For food safety and equipment accuracy, temperature sensors/probes have a range of applications for different storage/cooking methods.

     

    Oven Sensors:

    An average oven (for cooking meat and poultry) should be set for 325°F or higher. To maintain accuracy, a temperature sensor/thermometer should be used to ensure that the oven is functioning properly. Misleading oven temperatures can comprise both food quality and safety. The FSIS suggests that oven thermometers/sensors should be hung from a rack in the center of the oven. Be sure to test multiple temperatures (apart from 325°F) to ensure continued accuracy with increased/decreased heat. As per the FSIS advice, some ovens may "run hot" and any normal "variation" should be accounted for when measuring the overall temperature. 

     

    Microwave Probes:


    Albeit a bit tricky, microwave temperatures can be monitored using specialized probes or with built-in hardware. Consumer-grade microwaves often have this feature built-in, highlighted by this ehow.com article on Frigidaire Microwaves. Other consumer brands allow similar measurements. For commercial uses, however, there are more specialized probes for microwave ovens. These probes are typically immune to Electromagnetic Interference (EMI), Radio Frequencies (RF), and microwaves, and have an expanded temperature range (from 10°C to over 950°C). These probes, while often costly, give both accurate and precise readings of temperature for commercial microwaves. For these applications, ensure that yoursensor/thermometer can withstand the various types of interference to maintain accurate readings. 

     

    Freezer Sensors:

    Borrowing a few tips from our article "Where to place a Temperature Sensor: Vaccine Refrigeration", the same applies forFreezers. Each section of the Freezer has some temperature variation, and this must be taken into account when using a sensor/thermometer. The FSIS recommends placement between frozen food packages in the center of the freezer, with a 5-8 hour waiting period. After the waiting period, the temperature should read between 0-2°F. These "packaged" buffers are a useful variable, as they represent a common occurrence in freezer storage. The presence of the buffers and temperature readout will indicate if the Freezer is within a functional range (based on the controlled variable).

    If you missed it, See our article "Buffer Vials for Temperature Monitoring: Propylene Glycol vs Sand" for an accuracy comparison of buffer substances for temperature sensors and probes.

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  • Where to place a Temperature Sensor: Vaccine Refrigeration

    After the recent blog article about buffer vials (Glycol vs. Sand), we recognize that sensor placement is equally important fortemperature monitoring. Despite what we may know about the "temperature settings" for a refrigerator, the fact remains that several variables affect the average temperature within. Understanding "microclimates" within a refrigerator is important in determining ideal sensor placement. The following two variables are the most common contributors to these "microclimates":

    Defrost cycles routinely affect the temperature within a commercial refrigeration or vaccine storage unit. In simple terms, a defrost cycle is triggered to prevent buildup of frost on the evaporator coil, the key component of a refrigeration system. As the refrigerator frequently prevents frost buildup, defrost cycles will account for the most extreme temperature changes in an average day.

    Cooling Cycles, a common feature of any refrigeration system, can also significantly affect internal temperatures. Cooling cycles will vary to maintain a consistent temperature (preselected by you), and can account for small, periodic fluctuations in temperature.

     

    How significant are these variations? Are these variables important to the storage of vaccines, a particularily sensitive application that has little flexibility for temperature change? The answer is yes. Defrost cycles can change temperatures by up to 9°C within a refrigerator. Kudos to NIST.gov for this visual representation of temperature change within a Refrigerator. Even for commercial-grade refrigerators, these changes still occur.

    • #9: (Air-Top) shows the relative cycles, marked by the large peaks and valleys.
    • Temperatures of the "Lower Wall" are affected more by the defrost cycles than  the "Mid Wall".
    • The "Lower Wall" maintains a higher temperature (8>7) than the "Mid Wall".
    • Glycol vials  maintain temperatures that are only slightly affected by standard variables.
    • Overall, the only consistent 'zone' is the center of the "Middle" of the refrigerator. Buffer vials in this zone (Glycol or Sand) are relatively untouched by defrosting and/or cooling.

    describe the imagecommercial refrigeration

    Monitoring temperature in the correct 'areas' is a key consideration, particularily for vaccine storage. We can see thatrefrigerator air varies in temperature from 1-10°C, and this can compromise the safety of a vaccine. Check out this chart (via KDHeks.gov) for helpful tips on sensor placement for vaccine refrigeration, and be sure to keep variation in mind when placing temperature sensors!


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  • Buffer Vials for Temperature Monitoring: Propylene Glycol or Sand?

    Recently, Temperature@lert conducted a test of two separate buffer substances. Buffer vials are effective for ensuring the accuracy of a temperature sensor. This is important for sensitive vaccines and other substances that must be contained within certain temperatures, as per standard procedure or CDC direction. The test was conducted to determine which substance was affected more by external and internal microclimate factors.  

    For our clients that use buffer vials, temperature sensor accuracy is extremely important. Some of our clients use buffer vials for pharmaceutical and biological applications, such as using temperature sensors to indicate the relative temperature of vaccines and medicine. CDC has a chart that indicates specific temperature information for specific vaccines.

    Screenshot (11) resized 600

    With these specifics in mind, the Temperature@lert "Glycol vs Sand" comparison shows the relative effectiveness of the buffer substances alongside a naked sensor. The importance is accuracy, since appropriate storage temperatures are very precise (range of 6 degrees). A good buffer vial will not allow changes outside this 6 degrees range.

    Buffer Vial Media ComparisonIdeally, for temperature monitoring, this graph would look flat. The temperature would stay the same throughout the tests, with no peaks or valleys to represent change. But 'flatlining' is highly unlikely for any sensor, and might instead represent a flawed system/sensor. From the tests that we've conducted, there are some very simple observations to make. Primarily, it's obvious that the naked temperature sensor fluctuated significantly throughout the test, particularly during automated cycles (defrosting, etc). 

    More importantly, we see that the sand and Propylene Glycol are relatively similar in their fluctuation. During automation both buffers showed incremental changes in temperature. This is the ultimate goal; implement buffer substances as a shield to protect against minute and brief temperature changes. But which is more accurate? Which has more relevancy to practical application?

    The answer: While sand is an excellent and inexpensive buffer substance (2-3 degree fluctuation), the Propylene Glycol gives slightly more accurate readings. The closer look at the Refrigerator chart gives some insight. The Propylene is accurate within 1 degree, and appears to be less affected by the microclimate. The higher level of accuracy and lower rate of change is desirable for vaccine storage, as seen in the strict temperature guidelines. Still, neither substance shows unacceptable variation (over 6 degrees), and both are appropriate for sensitive application.

    Buffer Vial Media Comparison1

    As one might guess, we discourage the use of naked sensors in these environments, since our tests have shown their variation to be over 6 degrees on average. For biopharmaceutical applications, we consider changes of 6 degrees or less to be the "threshold" for sensor accuracy.

    One advantage of sand is that despite the slightly lower level of accuracy, it's less expensive and can be easily transported. As a liquid, Glycol can be difficult to ship and can spill on your other sensors and/or products. Of course we can ship unfilled buffer vials without sand for you to use with glycol.

    For Temperature@lert, our sand buffer vials hit a triumvirate of accuracy, cost-effectiveness, and handling simplicity. For the sake of our customers, these concepts are a huge part of our philosophy: smart, simple, and affordable.


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  • Can BioPharma Quality Assurance Specialists Do It All?

    When we imagine the biopharma industry as a whole, we tend to hover over the same key phrases: innovation, growth, discovery, etc. But in fact, with a few exceptions, the biopharma industry growth has gone sluggish in many states, and has grown in very few. 

    Citing recent data from the U.S. Bureau of Labor and a well-designed report from the Massachusetts Biotechnology Council(MassBio), of the 15 “leading” biopharma manufacturing states, only 5 states have increased employment. As a whole,industry employment has declined by 7.9% since 2002Though these numbers are concerning, Massachusetts seems to be one extraordinary exception to the rule. By state, Massachusetts is twice as dense (as other states) in terms of biotechnology research, development, and employment. Ironically, Massachusetts was the source of the recent Meningitis outbreak. 

    But this hasn't been the only mistake/outbreak of 2012. We can do a news search for past events, but more importantly, where is the proof that lessons have been learned? How can we tell if the mistakes of 2012 will happen again? At a high level, looking at data from the last 3 years, we're headed in the right direction in terms of hiring. 

    Diving deeper, is there evidence that biopharma and biotech companies are proactive?  Is quality control and best practices in vaccine storage a pressing concern of theirs, and what have they done to address it? 

     

    Screenshot (9) resized 600

     

    The answer, in short statistical form, is yes. The institution of best practices and safety guidelines is a hot button issue for the biotechnology and biopharma industry. In fact, “Quality Assurance” and “Quality Control” job listings have been on asteady rise since 2008. Job listings from MassBio.org show over an 80% increase for these specialized positions since then. Other positions have increased by up to 30%, but in contrast to quality assurance and control; we can see clear-cut dedication. The employment spike shows a true and proactive HR response to the rising concerns of vaccine storage and handling

    Still members of the biopharma industry must follow all best practice guidelines outlined by the CDC, and the push to hire “quality assurance specialists” is not a complete solution to the problem. Science fiction movies often illustrate the extreme horrors of vaccine mishandling and disease outbreaks that are caused by human error and/or relaxed security procedures. Despite the extremity of situational presentation in these films there really is an unspoken truth behind them. We cannot solely rely on capable employees. The rise in hiring for quality assurance and control positions is a promising sign, but there must be adequate technology to supplement the increase in manpower. Temperature monitoring is a good example, since employees must ensure that specific vaccines are stored at preset temperatures. However, truth is, no matter how many employees a company has, small changes in temperature must be monitored by certified and accurate technologies.  

    What we can learn from these various statistics is that proactive deterrence (a theme we’ve been tossing around quite a bit in other industries), is a multi-faceted animal. While individual states may show evidence of “employment growth” and perhaps an uptick in manpower related to quality assurance; vaccines and medicine require more than just a brain and body.

    Temperature monitors are ‘by-the-book’ devices that need to be used alongside competent employees. And in truth, all biotech and biopharma companies should have fault tolerant monitoring technology and quality assurance hardware. Institution of simple technologies such as buffer vials (for temperature sensors), will help decrease confusion and increase measurement accuracy for sensitive applications. The buffers provide a 'shield' around the sensor, preventing momentary temperature changes from an opened refrigerator door that can skew data or trigger false temperature alerts.

    New employees will appreciate the availability of helpful (and simple) technology, which is important to establish safe handling practices that have become standardized and remain consistent within the various industries. Hopefully, the investment has gone both ways, and this recent rise in specialized positions is piggy-backed by a push for 'battle-hardened' temperature monitoring systems. In preparation for 2013, we want to direct you towards a list of guidelines that must be followed as per the CDC for vaccine storage and handling. As the CDC shows, responsible quality assurance employees and reliable monitoring technology truly go hand-in-vial.

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  • Monitoring Devices and Vaccine Storage: A Global Concern

    We recently spoke with an individual from a reputable hospital who outlined a recent failure in one of their systems. According to the source, over 900 monitoring points were inactive as result of a faulty monitoring system. The question of"who's monitoring your monitoring device?" was part of our discussion on refrigerators, and is an extremely important issue. The upkeep of monitoring systems is an important piece of any "best practice" storage strategy. Unfortunately, this mishap at the US-based hospital is part of a larger theme around the world; that inadequate monitoring and storage of vaccines (and medicine) is still a significant problem.

    This basic infographic (kudos to msfaccess.org) shows a standard problem in vaccine storage and temperature control, as outlined by simple geographic location.

     

    Vacc Infographic ColdChain ENG 2012 web

    As we can see, Chad has environmental roadblocks to best storage practices for vaccines. This is only one of many majorconcerns in vaccine storage, and will continue to be a struggle for Africa as a whole.  In recent news, a bill “to provide for the establishment of a Drug Regulatory Authority of Pakistan” was passed.  This bill came nearly a full year after anestimated 40,000 cardiac patients in Lahore were given faulty drugs, leading to the deaths of nearly 100 people. Despite legal complications, this authority is absolutely necessary for the quality control and safety of Pakistan-based hospitals, clinics, and laboratories. Unfortunately, the 100 deaths constitute part of the basis for this bill. As quoted from the article, “In retrospect the lesson learnt from this experience is that decision-making should be guided by evidence, earlier on without the need for a catastrophic event to underscore its salience.”. This speaks to the deterrence question that we discussed last week with Hurricane Sandy and flooding;  preparation and prevention should not be based on a sole event or glaring weakness in any system. Preventative methods in Medicine should be proactive and progressive; weaknesses should be exploited before they can develop into larger problems. Whether the issue is environmental (like in Chad), financial, or legislative, the issue must be addressed sooner rather than later.

    There are obvious signs that the ‘authority’ is not the sole answer to the problem. The bill is referenced by statistics that estimate a presence of only 250 inspectors to monitor a variety of manufacturing facilities in one city. In terms of pharmacies in Pakistan, a 2005 survey from the International Journal for Health Care in Rawalpindi (3rd largest city) showed that only22% had qualified pharmacists on site, only 10% had temperature monitoring, and 4% alternative supply of electricity for refrigerators.  These numbers are shocking, given the Meningitis issue that we also discussed last week. It's also troubling that this authority has been established nearly 7 years after that survey was conducted; it's obvious to any reader that immediate action must be taken to improve the system. Still, the legal complications have made this "no-brainer" into a lengthy process.

    If we know that a single, isolated laboratory in Massachusetts can cause 300+ breakouts and 30+ deaths from one tainted batch of steroids, an entire city with less-than-adequate quality control in Pharmacies could be potentially disastrous. Quoted from the 'conclusions' of the 2005 survey, "Most drug sellers had fragmentary knowledge regarding drug dispensing and storage, and improper dispensing practices." Given the percentages listed, this ‘new’ authority will hopefully breathe a fresh breath into the Pharmaceutical industry of Pakistan.

    Since our induction, the Bio-Pharamceutical industry has been a primary (and sensitive) target for Temperature@lert.Temperature monitoring devices should be part of a larger prevention strategy for medicine (black matter in Steroids), and devices need to be regularly monitored and tested. Here at Temperature@lert, we have an excellent understanding of health guidelines and the necessary certifications that are needed for device application in the pharmaceutical industry. Unlike Property Management, in which consequences of inadequate temperature monitoring can translate into flooding  (bursted pipes) and overheating, the biopharmaceutical industry can house extremely sensitive (and valuable) research data and vaccines.  Particularly for vaccine storage, the cost of inadequate monitoring can be measured in lives lost, as seen in both the US and in Pakistan.

    Temperature@lert uses a National Institutes of Standards and Technology (NIST) certification process for clients who request official documentation of our accuracy. With this certification, our Temperature@lert monitoring devices can be used in the most sensitive of circumstances, including storage of vaccines. The automated alerts are designed to help avert vaccine contamination or irregular temperature fluctuation, and can be configured in a number of ways. Our SensorCloud portal allows alert setting in 5 or 15 minute intervals. This is particularly important for Pharmaceutical companies, where best storage "practices" must be used for the mission-critical storage units.

    For more information on NIST Certification, Temperature sensors for Biopharmaceutical applications, or Sensor Cloud, contactsales@temperaturealert for a free consultation.


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  • Is Your Refrigerator Running?

    Not sure? Then you probably should be monitoring it!

    All jokes aside, many neglect the importance of monitoring their refrigerator. Especially since many consider it to be a "set it and forget it" type of device. Without constant monitoring, one would be unaware if a piece of hardware (i.e. compressor, evaporator, condenser, expansion belt, pumps, fans, motor, etc.) failed, and as a result, the refrigerator is no longer functioning properly.

    The consequences of a failing cooling unit is not a pretty sight at all. From melted pools of ice cream, to spoiled food, to vaccine contamination, there are big issues when your cooling unit goes off and causes damage to the equipment, possibly losing years of compiled research.. Imagine walking into work and seeing just globs upon globs of spoiled food. This is a sight you should avert, not clean up.

    Although it's possible to plan for research dates, arrival of food products, among other cooling dates; it is not possible to plan for a malfunction. This can happen at any time without warning; therefore, temperature monitoring and alerting are necessary to deter any possibility or likelihood of malfunction. 

    Even with preventative measures, malfunctions can still occur. For example, Harvard's McLean Freezer's  containing brains for research on Autism and other neurological conditions. Their freezer had malfunctioned causing 150 brains to decay and decompose. A loss of this magnitude is not only financially damaging but has potentially set back research on neurological conditions for a decade. This type of research is truly priceless, and illustrates that the importance of proper storage, temperature monitoring, and temperature fluctuation extends well beyond financial cost. Unfortunately, the residual effects of lost data can be more damaging than the replacement of equipment and subsequent recovery.

    The CDC (Center for Disease Control) estimates that 17%-37% of vaccinations are improperly stored. However, members in the medical and pharmaceutical industry are not the only ones affected by malfunctioning monitors. As well, members of the food and beverage industry suffer from malfunctioning cooling equipment.

    Pipeline Restaurant's CEO Ben Wood decided to avert disaster rather than clean it up, “walk-in refrigerators fail more often than you’d think.  With Temperature@lert, we can correct the problem before it adversely impacts our business. Anyone who has ever experienced a refrigeration failure will agree that this is a no-brainer purchase. Now, the problem is fixed before it impacts our business.  I love these little devices!”

    For refrigeration needs, we suggest either our WIFI or CELL device. The CELL has a backup battery that can transmit even during a power loss. Our WIFI is also an excellent option if you currently have an implemented UPS backup power as well. Either device combined with our temperature sensor can help you monitor more efficiently and alert you to any problems. Specialized sensors and accessories are available as well, such as stainless steel tipped temperature probes for submerging in liquid, expanded range probes for cryogenic temperatures, and buffer vials (which prevents the dreaded "false alarm" from an open cooler door)

    Learn How to Monitor Your Refrigerator

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  • ALERT! New CDC Interim Vaccine Storage & Handling Guidance Out Now

    As of October 10, 2012 the Centers for Disease Control and Prevention (CDC) announced several new important changes to the Interim Vaccine Storage and Handling Guide. According to the CDC, these guidelines are now to be used by both public and private sector providers. 

    Here are the new changes to the guidelines (via CDC website): 

    • (1) Use of a biosafe glycol-encased probe or a similar temperature buffered probe rather than measurement of ambient air temperatures, and;
    • (2) Use of digital data loggers with detachable probes that record and store temperature information at frequent programmable intervals for 24 hour temperature monitoring rather than non-continuous temperature monitoring, and;
    • (3) Use of stand-alone refrigerator and stand-alone freezer units suitable for vaccine storage rather than combination (refrigerator+freezer) or other units not designed for storing fragile biologics, such as vaccines, and;
    • (4) Discontinuing use of dorm-style or bar-style refrigerator/freezers for ANY vaccine storage, even temporary storage, and;
    • (5) Weekly review of vaccine expiration dates and rotation of vaccine stock.

    A simple system such as our CELL Edition has not only 24 hour temperature monitoring but power loss monitoring as well. By plugging our temperature sensors with our buffer vials in, our system will give you the ability to properly monitor according to the new CDC guidelines. If needed, NIST certification is available upon request. 

    Please contact us for more information or for a quote on how to accurately monitor your vaccine storage unit(s). 


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