temperature@lert blog

  • FSMA on Small and Mid-sized Suppliers

    What doesn’t kill me makes me stronger is no longer an attitude most can afford.


    FSMA, the Food Safety Modernization Act is here. Signed into law in 2011, final and proposed rules are in place. The Institute of Food Technologists (IFT) website has a convenient chart describing the timing of proposed and final rules. (Link to Source)  Many companies have FSMA training completed or scheduled for their staff, especially larger, global suppliers. Despite the headlines and publicity, many small and midsized suppliers may not be prepared to meet the new regulations. (For reference: Link to US FDA FSMA Source)


    Figure 1. Screenshot of IFT FSMA Rule Timeline site. Link to Source


    The Food Safety Tech website recently posted a piece by Randy Fields titled Despite Exemptions, Compliance Will Not Be Optional For Small Suppliers. (Link to Source) The author starts with a well publicized food safety case that made national headlines as one of a continuing saga of such cases that appear each year. Most importantly, the piece notes that in an earlier case not only the supplier who declared bankruptcy and went out of business, but the country’s largest retailer were sued, a case that ended in an out-of-court settlement. The message is clear, “both suppliers and retailers are now responsible for everything they sell.


    With FSMA finalization now underway, the FDA mandates that retailers and suppliers have documentation that verifies their supply chain’s regulatory compliance is readily accessible for government inspection.”  As noted above, the largest suppliers, ones that typically sell the majority of our foods are likely to have procedures and systems in place for both production and distribution, minimizing their risk. And because they have “deep pockets”, they are likely to hold themselves to a very high standard to avoid problems, bad publicity and potential litigation. With these companies, outbreaks on a national scale are possible which means national headlines, giving any investment they make in food safety a high priority.


    The author notes one significant concern for small businesses: wholesalers and retailers may find the risk of using small businesses that may be exempt from FSMA requirements and that may not have the resources or knowledge to supply FSMA documentation to major retailers too great, leaving these suppliers for other sources. Suppliers of fresh, locally grown produce and foods could be in this category.


    What can these small, local concerns do? Fortunately the author notes that “affordable, interoperable systems have been developed to address the market need for receiving, storing, sharing and managing regulatory, audit and insurance documentation.” Employing such systems can allow “suppliers of any size can also track products as they move through the supply chain and trace them back in the event of a recall” should one be necessary. Of course with the proper HACCP plan in place to augment such systems, small suppliers will have the tools to make such an event unlikely.


    Figure 2. Kate’s Homemade Butter http://www.kateshomemadebutter.com/ (left) and Figure 3. Vermont Creamery http://www.vermontcreamery.com/ (right) are carried by major market and specialty food stores across the U.S. These and thousands of similar, regional, small, specialty product manufacturers and distributors will need to examine the impacts of FSMA and take actions to insure their continued success


    A key takeaway is “having a comprehensive food safety system is quickly becoming a competitive advantage.” Local, specialty products that are desired by consumers can provide small suppliers with a loyal consumer base, one willing to put a premium price on such products. Larger retailers who carry these products may become increasingly risk averse. Employing both HACCP and FSMA to their operations can help insure continued success for these small businesses.


    Temperature@lert provides cost-effective, fault-tolerant wireless temperature monitoring solution for organizations of all sizes. Our products and services can help bring a food processor, distributor, wholesale or retail outlet into compliance with minimal training or effort. For information about Temperature@lert’s Cellular and Sensor Cloud offerings, visit our website at http://www.temperaturealert.com/ or call us at +1-866-524-3540.


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  • Starting with the Basics in Pharmacy Temperature Monitoring

    Three down, one to go: Food and Beverage Coolers.


    ✓  Store food products in a temperature-monitored 
    and optimal for shelf-stable
    ✓  Store non-refrigerated medications in a temperature-monitored environment optimized for food safety
    ✓  Pharmacy refrigerator and freezer temperatures monitored and optimized for refrigerated and frozen medications
     ✗  Pharmacy food refrigerators and freezer temperatures monitored and optimized for refrigerated and frozen food products


    So far we’ve looked at store temperature as a good indicator of shelf-stable food and medication storage conditions that maintain food and medication quality and safety. We’ve also looked at refrigerated and frozen pharmaceutical storage temperatures as a good indicator of the safety and efficacy of these medications. And we’ve looked at the benefit of automatic temperature monitoring to help insure that when temperatures exceed or fall below recommended storage conditions, particularly those devices that provide alert and alarm messages when out of range conditions occur. It's time to turn our attention to refrigerated and frozen foods.



    Figure 1. Frozen and refrigerated food coolers are common in pharmacies, offering customers an alternative to grocery and convenience stores while they shop for pharmacy items.


    Generally I’m comfortable buying food from pharmacies, especially when prices are fair and it’s convenient. Because turnover can be longer than other stores I often check expiration dates more diligently than grocery stores. I have never found out of date items, so my confidence is growing.


    That being said, the task of food vendors all over are insuring their their frozen food coolers keep food frozen. In the summer, especially in humid climates, even the best glass front coolers fog up and customers open the doors to browse, complicating the problem of maintaining freezer or refrigerator temperatures. This may be one reason grocers, convenience stores and pharmacies keep their stores cold, to prevent or minimize condensation on freezer doors and prevent frozen food from partially thawing.


    In my mind the first task of pharmacists and pharmacy managers is to insure the safety and efficacy of refrigerated and frozen medications with regular, preferably automatic temperature monitoring. The second task is to do the same for room temperature drugs and food products both of which have similar storage requirements. Frozen and refrigerated foods can be added with little effort.


    I could argue that frozen and refrigerated food cooler monitoring is as important as those used for medications. This is because food borne illnesses can be attributed to food stored at elevated temperatures, temperatures where harmful microorganisms grow and multiply quickly. Indeed, we read many more cases of food poisoning or food borne illnesses than those from medications and the liability can be just as significant in either case.


    The U.S. Food and Drug Administration (FDA) recommends the following for refrigerated and food storage. (Link to FDA Source)


    • Keep the refrigerator temperature at or below 40° F (4° C). The freezer temperature should be 0° F (-18° C).

    • Stick to the "two-hour rule" for leaving items needing refrigeration out at room temperature. Never allow meat, poultry, seafood, eggs, or produce or other foods that require refrigeration to sit at room temperature for more than two hours, one hour if the air temperature is above 90° F (32° C).

    • Refrigerated ready-to-eat foods such as luncheon meats should be used as soon as possible. The longer they're stored in the refrigerator, the more chance Listeria, a bacterium that causes food borne illness, can grow, especially if the refrigerator temperature is above 40° F (4° C).

    The danger for pharmacies is that when food and freezers lose power, break down or have doors left ajar can warm up quickly, and like drugs, food safety can be compromised just as quickly. Fortunately when a store loses power, keeping freezer and refrigerator doors closed will delay products from being exposed to elevated temperatures. But if a manager or pharmacist opens the store the morning after a power outage s/he will not know what the freezer and refrigerator temperatures were overnight and which foods or drugs are safe unless there is an automatic temperature monitoring device recording these events.



    Figure 2. Pharmacists and pharmacy managers may not be able to control all conditions to keep refrigerated and frozen drugs and food safe, but automatic temperature monitoring devices can improve their chances greatly. Link to Source


    Of course it would be best if a manager, pharmacist, or staff member were alerted to the problem and took action before products were exposed to potentially harmful temperatures. The next and final piece in this series will explore options for temperature monitoring to both meet regulations and keep drugs and food safe.


    Temperature@lert provides cost-effective, fault-tolerant wireless temperature monitoring solution for organizations of all sizes. Our products and services can help bring a pharmacy, food processor, distributor, wholesale or retail outlet into compliance with minimal training or effort. For information about Temperature@lert’s Cellular and Sensor Cloud offerings, visit our website at http://www.temperaturealert.com/ or call us at +1-866-524-3540.



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  • Survival Guide: Food Service Power Outages in Restaurants

    Restaurants are fast paced and hectic on a normal day, but add a power outage into the mix and it can cause a lot of problems. It can be a challenge to keep up with the practices of food safety while in the middle of a power outage due to the amount of equipment that relies on electricity. A good way to focus on keeping up with the food safety protocols is to focus on the one main goal: making sure the frozen and refrigerated food stays below 41 degrees. This means not putting any partially cooked food into the refrigerators during the outage.

     

    That being said, it’s not allowed to process or handle any food during a power outage. To do this, you'll need to contact the local health department about an alternative power source and be able to prove there is the ability to wash hands under proper water temperatures, and have the correct lighting and enough power for needed equipment are necessary.

     

    restaurant kitchen

     

    It’s important to be prepared for the outage at any time, so keeping a written plan with standards and procedures is a must. That way, there are no questions about what should be done. Keeping track of temperature in the freezers is another vital step. To prepare for this, having temperature monitoring helps out tremendously. It gives the ability to always know if temperature danger zones are being reached, and ensure that the right protocols are being met. Temperature@lert’s cellular temperature monitoring would come in handy for this, because it sends text and phone call alerts when power outages happen and when temperatures are rising quickly in freezers.

     

    Other preparation for outages is to keep pre-frozen containers of ice in the freezers, that way the freezers and refrigerators have a longer longevity of maintained temperatures because of the ice. Having a knowledge of whether there are any block ice suppliers near by that can be quickly contacted is also a best practice. It would be recommendable to have a couple of coolers on hand so that you can quickly fill it with ice and food; food that would otherwise be thrown away due to the rising temperatures. The coolers would provide the food with the necessary temperatures it needs to maintain in order to avoid the danger zone.  

    food cooler

     For the safety protocols of when food needs to be tossed, refer to part one of the survival guide, along with part two for tips on how to handle school cafeteria power outages. With proper preparation for power outages, it’s easy to keep composure and follow the right procedures to maintain a safe environment. Look out for the last part of this survival guide for tricks and tips on keeping cool in a food retail facility.

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  • Are You Over-Cooling Your Data Center?

    Ice cream and servers both need care, maybe not the same environment.


    Ice cream season is here in full force this hot, sticky Boston August. My favorite is pistachio, not the green stuff but the white kind, like Ben & Jerry’s Pistachio Pistachio. Pistachio is among my wife’s least favorite flavors, which means I get it all to myself; she gets to pick her own which these days has the words salted caramel in it. What does ice cream have to do with data center servers? Apparently data center managers keep their server rooms very cold, which means both require a significant amount of energy to maintain their integrity.


     

    Figure 1 (Left, Link to Source) and Figure 2 (Right, Link to Source) have something in common, they both require a significant amount of energy to keep them cool and happy.


    According to the July/August 2015 issue of Data Center Dynamics magazine (Link to Source) one data center professional states that server rooms with server inlet temperatures below 24°C (75°F) is a sign of paranoia. Author Peter Judge notes data center managers are overworking their cooling systems, overcooling their spaces, “wasting vast quantities of energy and - ironically - contributing to global warming and melting the world’s polar ice caps.”  Judge points out that despite ASHRAE’s widely accepted guidelines for server inlet temperatures of 27°C (80°F), enterprise data centers are “seriously lagging” in raising temperatures. If polar ice caps are melting, can ice cream be far behind?


    An early 2015 IDC survey contacted 404 US data center managers with 100 or more physical servers. Results found that 75% were operating below 24°C (75°F) with only 5% at or above 27°C (80°F). The article further notes that these sites have PUEs between 2.4 to 2.8, therefore 60% to 65% of the power they use is not used for IT equipment, but rather cooling systems.


    The paranoia stems from being risk-averse, a common trait for data center operators that increasingly guarantee greater and greater uptime and availability to their customers as a competitive advantage. There’s a significant amount of data and inertia to change something without knowing the consequences, and experimenting on a money making data center is not generally allowed. Additionally, the author notes an upcoming study that surprisingly shows raising data center temperatures can actually increase energy usage likely due to increased server fan usage to assist server cooling at higher temperatures.


    The fact is that complex systems and environments like data centers can present surprises. The granularity of temperature mapping needed to help visualize hot and cold spots in data centers is often not available and even if it is, server utilization can change it over time. Modeling such a system may be very complex, possibly too complex for existing modeling tools; simpler static models may not be as useful as expected.



    Figure 3 (Left Link to Source) Rube Goldberg competition entry looks complex but is very simple and predictable compared to Figure 4  (Right Link to Source) showing a dynamic data center temperature and airflow CFD model.


    The author provides some alternatives to consider such as ensuring you are using hot and cold aisle containment which will help improve the efficiency of traditional air conditioning technology. Employing direct outside air cooling can help in many if not most locations, even if the approach is used only for a portion of the day or year. And adding water evaporation on the cooling coils when outside temperatures can help; such an upgrade may not be physically feasible and can require increased maintenance.


    The fact is data center cooling is a complex system with hundreds if not thousands of moving parts including site climate and weather. What works in one location and with one set of equipment may not provide the same results at a different site. Server and IT HVAC and energy equipment manufacturers can perform experiments but not everywhere and under every condition. The semiconductor industry found that industry consortia can provide significant insight to advanced practices in building design and environmental control. This requires equipment suppliers to work together in a pre-competitive environment as well as support by regional governmental entities. LBL performs experiments for the data center industry but it is only one organization and one location. Perhaps as the industry continues to move toward standardization and consolidates there will be the will to cooperate. For the sake of the industry’s image, the environment and ice cream lovers worldwide, one can only say that sooner will be better.


    Temperature@lert provides cost-effective, reliable, fault-tolerant wired and wireless temperature monitoring solution for organizations of all sizes. Our products and services can help bring peace of mind to small and mid-sized companies and their data centers with minimal 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.


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  • Temperature is Critical for Safe, Effective Refrigerated Drug Storage

    Refrigerated medications need special care; guidelines and regulations help with direction.


    In the previous piece we looked at room temperature storage of pharmaceuticals. Many of us are familiar with the requirements of the prescriptions we have filled and take home. Similar information can be found on pharmacy websites. For example, the CVS website FAQs provides the following information for Lisinopril a common high blood pressure medication: Link to Source


    Where should I keep my medicine? (Non-Refrigerated Drugs)

    • Keep out of the reach of children.

    • Store at room temperature between 15°C and 30°C (59°F and 86°F). Protect from moisture. Keep container tightly closed. Throw away any unused medicine after the expiration date.


    Most households maintain these conditions, therefore drug effectiveness and safety are maintained. But what about refrigerated medications or those stored in a freezer in the pharmacy? These require a close look; particularly since regulators often review refrigerated and frozen drug storage conditions during audits.


    What types of drugs require refrigeration? Again, the CVS website is helpful here and provides a list of fifty common prescription medications that require refrigeration. The list includes commonly recognized generic and brand names such as insulin, Cipro and Enbrel. Most of those listed are solutions, suspensions, vials or capsules. Link to Source [See The American Society of Health-System Pharmacists (ASHP) 2008 Pharmacist’s List publication tited Stability of Refrigerated and Frozen Drugs Link to Source for storage conditions.for an extensive list of drugs.]


    While these drugs are for use at home, medical offices and pharmacies store medications to be administered on site such as vaccines. Fortunately the US Center for Disease Control (CDC) has published extensively on safe storage and handling of vaccines for their Vaccines For Children (VFC) program. The CDCs 2014 Vaccine Storage and Handling Toolkit (Link to Source) specifies storage temperature between 2°C and 8°C (35°F and 46°F). This range is also commonly used for medications other than vaccines which makes a pharmacist’s job easier.


    To ensure the vaccine’s efficacy is maintained, VFC providers must maintain a log of at least temperature readings each day using a certified thermometer. While many pharmacies and medical offices use manual reading and recording, many more are deploying temperature monitoring devices that record temperatures automatically and continuously, even when the store is closed and no personnel are present. Some US states require such devices; check local regulations to determine the requirements in your state. Generally a manual reading and logging is also required even where automatic monitors are deployed, most likely so that staff members will be aware of any out of range conditions since many automatic devices log the data but do not provide warnings or alarms when temperatures are out of range. (Look for more about this in our final piece.)


    Figure 1. CDC VFC 2014 Vaccine Storage & Handling Toolkit requirements for refrigerated and frozen vaccine storage temperatures apply to participants. CDC requirements are often adopted by state health agencies for all refrigerated medications.



    temperature vaccine log, CDC, VFC

    Figure 2. Temperature log for refrigerated medications highlighting CDC VFC limits. 

    [Download your copy]


    Pharmacies, hospitals and medical practices participating in the VFC program are required to take readings with a certified thermometer twice per day, in the morning and evening. Readings are manually recorded on temperature logs. These logs are sent monthly to the CDC for review and action when needed. Some states require automatic temperature monitoring equipment to insure that there are no gaps in temperature logs. Automatic temperature monitoring equipment can be configured to record temperatures every minute, or in any interval. Commonly intervals of 15 minutes are set for pharmaceutical monitoring. Data is sent to state health departments monthly.


    In some devices data logs are manually downloaded to a computer hard drive by USB weekly or monthly. Monitoring with such devices with intervals less than 15 minutes can fill up data storage capacity and exceed limits on many devices. WiFi temperature monitors may be able to be configured to automatically download data to a networked computer negating the need to manually download. WiFi and wireless temperature monitoring devices rely on the stability and reliability of the local IT network and electric power grid, and when these services are interrupted, not an uncommon experience, temperature readings can be lost.


    Figure 3 (left). Manual plot of twice daily thermometer readings. Figure 4 (right). Sensor Cloud plot of 60 minute interval cellular temperature monitor readings. Link to Source Note the elevated temperature event in the right image would have been missed in a twice-per-day manual plot.


    To minimize reliance on manual operation, IT networks and electrical power, leading pharmacies have begun to adopt cellular temperature monitors that communicate when IT networks and power supplies are interrupted. Data is sent via major cellular providers to reliable, redundant data centers, ensuring data integrity. Pharmacists can access data via a web browser and set password controlled temperature alert and alarm limits. Some devices provide email, text and voice message alert and alarm messages to insure harmful conditions do not go unnoticed, on Saturday at 2:00 AM for example. Such an approach represent the leading edge of fault-tolerant operation.


    Temperature@lert provides cost-effective, fault-tolerant wireless temperature monitoring solution for organizations of all sizes. Our products and services can help bring a pharmacy, clinic, wholesale, or retail outlet into compliance with minimal training or effort. For information about Temperature@lert’s Cellular and Sensor Cloud offerings, visit our website athttp://www.temperaturealert.com/ or call us at +1-866-524-3540.


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  • Are We Ready for Battery Powered Data Centers?

    What has changed in the 18 months since we looked at this idea? Lots!


    We have published several pieces in our occasional series concerning energy and data centers, particularly green or non-traditional power options. Topics range from using data centers to heat our homes and businesses to volcano powered data centers, or more properly, geothermal powered data centers. In our December 2013 piece titled Battery Powered Data Centers? We looked at the possibility of operating data centers using then state of the art battery technology. Link to Article The conclusion at that time was although projects were underway, cost and performance data were lacking, therefore proceed slowly.


    A demonstration project in Oregon installed a 5 MW array of 1,440 rack-mounted lithium-ion battery modules supplied by Indiana based EnerDel, a privately held company supplying energy storage, hybrid transportation and industrial systems. Link to EnerDel



    Figures 1, 2. EnerDel has expanded to the transportation industry as shown in the bus battery pack (Left Image) while Tesla has branched out into the non-transportation sectors with products like the Tesla Powerwall (Right Image).


    One company to watch mentioned in the piece was Tesla Motors. The article gave a quick, back of the envelope calculation that a 500 10kW rack data center would need to have 2000 Tesla Model S cars to operate the racks and the remaining data center electrical needs. Such an implementation would have made Tesla Motors very happy and the data center employees who took the Model Ss for a recharging run even happier, no one seems to have taken the leap.


    Recently Tesla introduced their Tesla Energy business. Link to Announcement Tesla has begun marketing “a suite of batteries for homes, businesses, and utilities fostering a clean energy ecosystem and helping wean the world off fossil fuels.” With this announcement Tesla has branded itself as an energy innovation company and its mission to enable zero emission power generation.


    The flagship product is Tesla’s Powerwall, a lithium-ion device available in 7kWh or 10kWh sizes. Of course the “zero emissions” claim is for the battery, not the recharging power generation. Tesla foresees the device being used three ways.


    1. Load Shifting - charging during low demand, lower electrical price periods and then powering a home during high demand, higher price periods, saving the homeowner the rate difference. Homeowners will need demand pricing capability for this to work.

    2. Increase Self-Consumption of Solar Generated Power - some homeowners can sell excess power back to the utility, many cannot or do so at rates below incoming power. Powerwall uses could conceivably store and use their own power and realize the full value. State regulations could promote or deter this, stay tuned.

    3. Backup Power - provide power for times when utility power is interrupted. Areas susceptible to ice storms would benefit. An additional feature would be safety versus gasoline powered generators where some individuals have been overcome when generators were operated in unventilated, indoor areas.


    As a Boston area homeowner, the backup power is very interesting since my utility connection is via overhead wires located underneath giant deciduous trees whose limbs are challenged by age and the elements. The utility spends the warmer months pruning back trees that get close to the wires from pole to pole, but the overhead canopy covers these wires and the cable to our home with tons of oak and ash, so the chance of losing power somewhere along the miles of tree lined streets is very high.



    Figures 2, 3. “Halloween 2011” nor’easter coated trees with wet snow, ice, taking down power lines across the northeast. Because the storm came before many trees had lost their leaves, the amount of snow sticking to the branches increased greatly leading to even healthy trees coming down onto utility lines.  Left Image  Right Image




    One only needs to recall the late October nor’easter that dumped 32 inches of snow on Massachusetts and left 3.4 million homes and businesses without power, in some cases for more than ten days. While daytime temperatures warmed to the low 50s, overnight temperatures were below freezing.


    But is Tesla ready for businesses like data centers? 

    Temperature@lert provides cost-effective, reliable, fault-tolerant wired and wireless temperature monitoring solution for organizations of all sizes. Our products and services can help bring peace of mind to small and mid-sized companies and their data centers with minimal 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.


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  • Survival Guide: Power Outages and Cafeteria Food Service

    Power outages in school cafeterias are without a doubt hectic. Without working stoves and ovens, the ability to feed students what they are expecting, and what was being expected to be made becomes a problem. There are solutions to these issues by utilizing both proactive and reactive methods. 

     

    Following the rules of the previous guide is important: toss what needs to be thrown away, and if there was food being cooked and it didn’t get completely cooked, get rid of it. It’s a hard task to do, but the safety of the students is more important than the budget. So, always remember to:

     

    - Pay attention to the time. Timing is EVERYTHING.


    - Cease all cooking and keep warm food out of refrigerators and freezers to avoid rapid temperature increases


    - After four hours, food must be discarded if falling between 41 and 140 degrees F in or out of the refrigerators


    - When in doubt, throw it out


    - Fruits and vegetables can be left out longer than meat

      

    If the power outage continues to last for more than a day and there are orders coming in that day from vendors, if at all possible, be sure to cancel or reschedule those orders. Bringing in more food that could be compromised during the outage will just cause more problems.

     

    If school is still being held in session during the power outage, there are other issues to take into consideration. These issues include feeding students and food preparation.


    cafeteria, food service

     

    The lunch rush is a stressful time of the day for cafeteria workers: making sure every student is fed is a vital aspect of the job and important to the school. Without power to make the food, this becomes a major problem.

     

    To avoid this, make use of the ingredients that don’t require cooking to make: use any cold cuts and vegetables to make sandwiches and make use of any fresh fruit or fruit cups on hand. This way, food that would be otherwise be sitting in the fridge and possibly having to be thrown away due to the length of the outage is being eaten.

     

    Sherman High School’s cafeteria team didn’t let a power outage get in the way of feeding their students and making use of the food they had on hand that would otherwise need to be tossed eventually. Only part of the school was affected by the power outage, but the cafeteria suffered without any power, so there were still mouths to feed without power to do so. For breakfast, they made use of the cereal, fruit, and milk that was on hand. For lunch, they were luckily able to grill hamburgers on a grill. This way, they were able to use meat that had the possibility of eventually having to be tossed from the lack of power.

      

    school, cafeteria, power outage

    Image 1 – Cafeteria workers of Sherman High School making use of their resources during a power outage

     

    Disaster is avoidable during power outages. Maintaining composure is the first step in keeping a safe environment during power outages. Having temperature monitoring keeps stress levels low and gives you insights about the food in the refrigerators and freezers; this allows you to make sure foods are not reaching temperature danger zones. Temperature@lert’s cellular temperature monitoring system will keep updates flowing via text message and phone calls before danger zones are even reached. These alerts give you the ability to take measures without having to guess how long until corrective measures need to be taken. This way, the main priority can be making sure that students are taken care of. 


    For more on power outages in regards to restaurants, be sure to check back for the third installment of the power outage survival guide series.

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  • Pharmacy Ambient Temperature and Medication Efficacy

    How do I know those pills I just bought that were sitting on the shelf are still good?


    In the previous, second piece of this series about temperature monitoring and best storage practices in retail pharmacies we looked at the shelf-life of food as it relates to ambient temperature inside the store. In general, shelf-stable food products including canned, bottled and packaged goods are designed to be stored below 85°F (30°C), ideally 70°F (21°C). But what about pharmaceuticals stored at ambient store temperatures, those bottles of pills, capsules, and tablets sitting there on the shelf?


    Figure 1. Shelves of pills, tablets, etc. in a modern pharmacy. Link to Image


    When pharmaceutical companies develop medications, they examine many factors such as effective dose, side effects, how it needs to be administered (orally, injection, transdermal etc.), effects of overdose, safety, and efficacy. A significant amount of time is spent understanding the effects of storage on the preparation. These studies will determine if the medication is stable at room temperature, needs refrigeration or needs to be frozen, as well as degradation during such storage. How this applies to pharmacies takes us on a journey.


    Fortunately room temperature pharmaceutical storage is subject to regulation in the U.S. The U.S. Food and Drug Administration (FDA) regulations in CFR 21 (CFR2111) defines stability testing for pharmaceutical manufacturers, and notes testing shall be used in determining appropriate storage conditions and expiration dates. (Section 211.166) In 21CFR205.50 the FDA guidelines for State Licensing of Wholesale Prescription Drug Distributors states that all facilities where prescription drugs are stored, warehoused, handled, marketed or displayed to be maintained properly. FDA wording follows in italic.


    (c) Storage. All prescription drugs shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs, or with requirements in the current edition of an official compendium, such as the United States Pharmacopeia/National Formulary (USP/NF).


    (1) If no storage requirements are established for a prescription drug, the drug may be held at "controlled" room temperature, as defined in an official compendium, to help ensure that its identity, strength, quality, and purity are not adversely affected.


    (2) Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, devices, and/or logs shall be utilized to document proper storage of prescription drugs.


    (3) The record keeping requirements in paragraph (f) of this section shall be followed for all stored drugs.


    Pharmacy regulations are issued by each state. In general they refer to or mirror the FDA guidelines which often refer to manufacturer’s guidelines. In Massachusetts for example, 247CMR9.00, section 901(5) states, While on duty, a pharmacist shall be responsible for proper preservation and security of all drugs in the pharmacy or pharmacy department, including the proper refrigeration and storage of said drugs. Massachusetts 247CMR9.00 for wholesale druggists, section 7.04(3) states,


    All prescription drugs shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs, or with requirements in the current edition of an official compendium such as the United States Pharmacopoeia/National Formulary (USP/NF).

    (b) If no storage requirements are established for a prescription drug, the drug may be held at "controlled"room temperature, as defined in an official compendium, to help ensure that its identity, strength, quality, and purity are not adversely affected. 

    (c) appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, devices, and/or logs shall be utilized to document proper storage of prescription drugs.

    (d) The record-keeping requirements in 247 CMR 7.04(6) shall be followed for all stored drugs.

    What this boils down to is the manufacturer’s label defines the requirement. The good news is that manufacturers do publish storage conditions for drugs stored at room temperature which is defined by the U.S. Pharmacopeia as between 68-77°F (20-25°C). Take for example a common high blood pressure medication, lisinopril, also sold as Prinivil, Tensopril, Zestril, or Hipril. The image below (Figure 2) is from the information sheet included with Zestril, AstraZeneca’s version of lisinopril, and posted on the FDA’s site. The data sheet notes the recommended storage conditions for Zestril tablets: Store at controlled room temperature, 20-25ºC (68-77ºF)[see USP]. Protect from moisture, freezing and excessive heat. Dispense in a tight container. Note the reference to USP guidelines.


    More importantly, note the data sheet calls for a controlled room temperature. If I walk into a pharmacy that feels hot, I know the drugs stored there are likely to be degrading faster than expected. Fortunately many pharmacies keep limited quantities of any particular drug, so drugs that are in constant demand like lisinopril are not likely to be sufficiently degraded if exposed to elevated temperatures for short periods, Of greater concern are medications that have slow turnover. Pharmacies that regularly run hot can potentially compromise the efficacy of such drugs.


    Figure 2. AstraZeneca Zestril (lisinopril) storage conditions, from data sheet. Link to Form


    Pharmacy managers and pharmacists are responsible to keep the drugs under their management within recommended storage conditions. Automatic temperature and humidity monitoring systems can provide warnings and alarms when temperatures exceed or fall below the recommended range, providing pharmacy managers and pharmacists with the information needed to correct the issue when problems occur.


    Many have tasted wine that has been exposed to elevated temperatures for a period of time, vinegar comes to mind. Likewise, many have tasted bagged popcorn that has been exposed to elevated humidity for a long period of time. If I enter a store or pharmacy that is very warm and humid, I generally will not purchase items where the quality can be compromised. The same goes for prescription and OTC medications. Pharmacy managers, operators, and pharmacists are responsible to maintain an environment that keeps prescription medications within recommended temperatures. Pharmacies who let customer discomfort be the warning that things are too hot or humid are likely to see these customers disappear if the condition persists. Proactive programs to maintain ambient store temperature within manufacturer’s specification are good for patient outcomes and good for business.


    Temperature@lert provides cost-effective, fault-tolerant wireless temperature monitoring solution for organizations of all sizes. Our products and services can help bring a pharmacy, clinic, wholesale, or retail outlet into compliance with minimal training or effort. For information about Temperature@lert’s Cellular and Sensor Cloud offerings, visit our website at http://www.temperaturealert.com/ or call us at +1-866-524-3540.


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  • Survival Guide: Food Service Power Outages

    When dealing with power outages within food service, whether it is at a restaurant or school cafeteria, it can be a stressful situation with many decisions of what to do with food, what is safe, and when to discard. Sometimes during an outage, it’s hard to figure out what to do and how to deal with these decisions and whether or not the right one is being made. There are different solutions depending on what kinds of foods are being dealt with, whether it’s refrigerated, frozen, or being prepared. To prepare for these solutions, there are simple steps to follow for the guarantee for safe measures to follow.

     

    food safety, FDA, food temperature

     

    The first step in dealing with power outages is to take note of when the outage happens, as timing is everything when it comes to food safety. Secondly, cease all cooking that is happening. It’s good to note that if a power outage is two hours or less, it is not considered hazardous to food being handled under safe conditions. After two hours, any food that is being prepared, whether it is meat or cut fruits and vegetables, must be discarded. Do not put warm food into the refrigerators or freezers to avoid rapid temperature increase within the refrigerators. If warm foods are warming the area, it will only decrease the time before having to throw foods away. Whole foods such as uncut fruits or vegetables can be quickly put back into the refrigerator if needed and are still safe for consumption.

     

    Once again, timing is everything. When dealing with refrigeration, there’s up to four hours of safe time that food will be kept cold during an outage if the refrigerator is not opened or opened minimally. After four hours, food must be discarded, or dry/block ice can be used to maintain the cool temperature for up to two days. If there’s no ability to get ice to keep the refrigeration cool, uncut fruits, vegetables, and processed cheeses do not have to be thrown away after the four hours pass, while foods such as meats, dairies, and opened jars should be tossed.


    food safety audit

    Figure 1: Keeping track of what’s in the fridges and freezers during a power outage to ensure safety measures for different foods are being taken.

     

    With freezers, they can keep temperatures for up to 48 hours if minimally opened, and if it’s fully stocked. For half full freezers, they can last up for 24 hours, and it’s important to group food together to keep them colder for longer. If this happens, ensure to keep the food on its own trays, so if they begin to thaw the juices won’t touch the other foods. There are certain guidelines from the FDA for foods that can be refrozen if partially thawed.

     

    food safety, FDA food safety guidelines, FDA refrigerator, FDA freezer

    Figure 2: FDA standards for refreezing or discarding of food depending on thawing status

     

    It’s important to follow these refrigeration and freezer FDA guidelines while dealing with power outages in order to keep a high standard of food quality and safety. If there is ever uncertainty in whether or not a food is still safe, it’s better safe than sorry, so when in doubt, throw it out. If the food being prepared hasn’t reached the safe consumption temperature, throw it away. There is no way around having to throw half cooked food away during a power outage. Foods in the process of being cooked, especially cut, half cooked vegetables and meats are prone to bacteria and can quickly become harmful.

     

    There are, of course, certain foods that can be kept safely at room temperature. Foods such as butters, hard cheeses, dried and fresh fruits, herbs, spices, breads and pastries can all be kept at room temperature without harm coming to them, although depending on what it is, the quality can decrease. Don’t worry if these foods are left out during the outage.

     

    food 

    Upon restoration of power, it’s important to identify any hazardous foods that still need to be discarded, and check internal temperatures of potentially dangerous foods. If anything falls between being above 41°F or below 140°F, and has been for longer than 4 hours, it must be tossed. If it becomes worrisome that food in the refrigerator needs to be cooled at a faster rate, transfer it to the freezer for faster cooling.

     

    Using a cellular temperature monitoring can help prevent any surprises or temperature rises during an outage. With Temperature@lert’s cellular-based temperature monitoring, if there is a power outage, a text message will be sent to notify you of the outage. If temperatures begin rising at an alarming pace, a phone call alert is sent. With these alerts, it gives you the ability to begin corrective actions and prevent losses.

     

    Maintaining a safe environment is easy during a power outage. Following protocols from HACCP and the FDA ensure that there will be no issues upon the power returning. Throw away what needs to be tossed, and keep the fridge and freezer doors shut as much as possible. For tips on how to deal with school power outages, retail store power outages, and restaurant power outages; be sure to check for the next parts of the power outage survival guide series. 

     

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  • Battery Powered Data Centers Redux - Part 2

    Batteries may be ready for home applications, but are they ready for the big time: Data Centers?


    In the first part of this two part look at battery powered data centers we found that Tesla recently entered the battery electrical storage market for home applications such as emergency backup and metered energy cost savings. Companies like EnerDel that have active data center projects have been supplying industrial as well as transportation power options while Tesla up to recently has concentrated on the automobile market.


    Along with the Powerwall option for households Tesla is also making a play for commercial and business applications. Tesla’s announcement provides examples of commercial customers, one being Target. Select stores are conducting pilot studies incorporating Tesla Energy Storage batteries. “David Hughes, senior group manager, Energy Management, Target. “Tesla’s cutting-edge technology offers unique benefits to powering these stores, most importantly relieving stress from the electrical grid at peak times furthering Target’s investment in designing and operating energy-efficient and sustainable buildings.” (Link to Announcement) Here again, managing peak load demand is the goal and savings for large electrical energy users like Target can be substantial.



    Figure 1 (Left) shows an artist’s concept of an array of Tesla’s Powerpack Battery System on the roof of a retailer such as Target. Link to Image  Figure 2 (Right) shows the home market Powerwall (left) and the commercial Powerpack (right) for comparison. Link to Image


    Each Tesla Powerpack module is rated for 100 kWh. These batteries act like very efficient generators and can supplement the grid when needed as well as take advantage of storing power when rates are the lowest, overnight for example. The Return on Investment (RoI) for the Powerpack would be a function of the difference between peak and off-peak rates in any given location. Alternately, linking the battery array to a solar array would result in “free” electricity for storage, but the cost of the solar array would need to be added to the total RoI. In such cases, the DC output of the solar array could be used directly to charge the batteries, negating the cost of an inverter for the solar piece. Only the battery to AC inverter would be needed.


    Still, since companies like Target offer large opportunities for power suppliers, their cost both for grid power as well as battery and solar will likely be significantly lower than smaller enterprises. Someone surely has done the math, but there is no update of the test installation by Portland General Electric’s 5 MW EnerDel battery demonstration project in South Salem, OR. Because this is a public project there may be some economics forthcoming, but a search has turned up empty for this two-year old, $178-million project. (Link to Project Website http://www.pnwsmartgrid.org/)


    So what about data centers? Amazon Web Services may shed some light here. According to The Verge, “Amazon is using (Tesla) Powerpacks as part of a 4.8 mWh pilot program in Northern California to assist in running its Amazon Web Services platform. That’s 480 - 100 kWh Powerpacks. James Hamilton, an AWS engineer, said the technology would make it easier for the company to rely on renewable energy sources. Batteries, he said, would "bridge the gap between intermittent production, from sources like wind, and the data center's constant power demands." Amazon has been working with Tesla for the last year, viewing Musk's new Powerpacks as a way to reach its ultimate goal of "reducing the technical barriers limiting widespread adoption of renewables in the grid."


    One thought is lithium-ion battery technology is not without limitations. Looking at the artist’s concept drawing (Figure 1) what comes to mind for this New Englander is what that roof would have looked like this past winter when Boston had a record snowfall. Such installations would need to have additional support for the significant battery weight; add to that the weight of 9-feet of snow and there could be real concerns. The second is that lithium-ion batteries don’t like hot and cold weather. The graphs below demonstrate the issue of installations in cold and hot climates.



    Figure 3 (Left) Li-ion discharge times fall off dramatically at colder temperatures. Link to Source

    Figure 4 (Right) Li-ion battery capacity decreases markedly with increasing temperature, as is witnessed by Tesla car owners in Phoenix.  Link to Image



    Two thoughts come to mind here. First, data centers use large battery arrays as UPSs to bridge the time until the generators kick in. Enabling these UPS arrays to provide additional benefit such as renewable energy storage and smart metering savings can have real benefit to data centers with the right economics. In a power market like Northern California where the grid is stretched to the limit during hot summer days, such an approach could bridge the gap of a brownout voltage cut, reducing any electrical strain on data center electronics. Again, cost vs benefit is needed, but for high risk locations these calculations may look more like life insurance than not.



    Figures 5, 6. Amazon data centers in Virginia (Left) and Oregon (Right) may be candidates for battery storage.  Left Image Source   Right Image Source


    While there is hope for some light to be shed publicly on the Portland demonstration project, AWS and its competitors keep their costs and benefits close, so meaningful analysis will be difficult. According to Forbes, the Powerpack cost is $250/kWh which is below the $350/kWh calculated by a Texas power supplier as break even compared to the cost of a new power generator. (Link to Source) For the Amazon project that translates to $1.2 million in cost for the Powerpacks, plus installation and supporting hardware. Future announcements may help data center managers and owners make a meaningful estimate for RoI. Tesla is reportedly sold out on all products, a good sign that this technology offers real benefit. Stay tuned for updates as this story continues.


    Temperature@lert provides cost-effective, reliable, fault-tolerant wired and wireless temperature monitoring solution for organizations of all sizes. Our products and services can help bring peace of mind to small and mid-sized companies and their data centers with minimal 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.



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