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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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  • Why Sweat the Details?


    Complying with mandatory Good Manufacturing Practices (GMPs) can be stressful no matter which vaccine process your biotech, pharmaceutical, or medical company undertakes, but that preoccupation can also be reduced. As previously noted, GMPs are regulated by the FDA and fluctuate between broad and narrow, required and recommended. With the Code of Federal Regulations acting as a compliance manual, firms are expected to validate that their processes and products are safe, effective, and protected.

    Two regulations of particular relevance to vaccines are 21 CFR Part 10.11 and Part 11. First conceived from the National Childhood Vaccine Injury Act (NCVIA) of the late 1980s, Part 10.11 provides requirements for vaccine labeling and breaks down the process review as follows:


         - Proposed labeling must be submitted for pre-approval

         - Package inserts must be included with submission

         - Inserts must have sufficient instructions, warnings, and precautionary information

         - Post-approval surveillance based on medical literature and mortality reports determines whether labeling must be updated


    Added in 1997 and refreshed in 2003, 21 CFR Part 11 specifically deals with the collection and storage of electronic records and signatures:

    The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.

    The FDA monitors these electronic entries by requiring that, among other things, the following major components be accessible and accountable:

         - Validation of temperature parameters

         - Auditable data and action logs

         - Record protection


    Failure to provide adequate and consistent electronic documentation may lead to a compliance violation, but such regulatory hassles are avoidable. Technological advances in wireless temperature monitoring have made CFR compliance less intensive than ever. Through device and system automation, you can set temperature boundaries and receive email, SMS, and phone alerts if they are breached. Additionally, all actions and records are time stamped, logged, and stored within a secure cloud service. Your company’s ability to adhere to GMP guidelines will be one less concern in your day, which is what truly matters.

    Like any regulatory standard, the demands of GMPs are numerous, and an infraction costly, but with a proprietary wireless monitoring device and complementary system, you don’t have to sweat the details.

    We’ll continue with pharmaceutical products and their respective CFRs next week.


    Free Guide for Vaccine Monitoring


    Full disclosure: This writer is employed by one such supplier of wireless temperature monitoring systems, Temperature@lert, that help its users to meet complaince.

    Temperature@lert’s ZPoint Cellular Edition ensures that important electronic records (temperature and time logs, alerts, and alert responses) are documented and retained for one year within our Sensor Cloud service. Should the environment you’re monitoring lose power, the ZPoint Cellular Edition’s internal backup battery will keep the device and sensors operational for several days, allowing alerts and measurements to continue without interference. For more 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.



    Temperature@lert Cellular Edition


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  • The Maturation of Good Manufacturing Practices

    When manufacturing, handling, or selling bio-pharma or medical products, it’s critical for a biotech or pharmaceutical business to operate in a manner that adheres to the government’s Current Good Manufacturing Practice (CGMP) regulatory requirements. Below are some historically important points from the evolutionary timeline of this federally constructed and imposed standard.


    - Upton Sinclair’s muckraking novel The Jungle inspires Congress to pass the Pure Food and Drug Act of 1906—the fundamentals of CGMP derive from this piece of legislation.


    - After the Messengill sulfanilamide tragedy of the 1930s, the Federal Food, Drug and Cosmetic Act of 1938 requires drug companies to confirm that products are safe for consumers, bolstering the original law.


    Frances Oldham Kelsey of the FDA withholds thalidomide from the U.S. market, protecting pregnant women’s nervous system from the horrific effects of the ineffective painkiller.


    - The initial GMP guidelines, requiring that drugs be proven as safe and effective, pass as drug law amendments in 1962.

    - Subsequent laws of the 1960s and 1970s address issues like data documentation, packaging and labeling, and tampering.


    Temperature@lert Blog: The Maturation of Good Manufacturing Practices

    Drug manufacturing has changed dramatically since the dawn of the 20th century.

    These days, CGMP, through the Code of Federal Regulations (CFR) and FDA enforcement, require that pharmaceutical companies utilize and employ the latest technologies and processes and training standards. These generally include, but are not limited to, the following:

    - Maintenance, calibration and validation of equipment

    - Condition of facilities

    - Qualifications and training of employees

    - Reliability and reproducibility of processes

    - Test method validation

    - Handling of complaints

    In addition, Biotech and pharmaceutical firms should pay particular attention to section 21 of the CFR. Violations, especially egregious ones, may lead to criminal penalties. Included sections deal with the manufacturing, processing, packing, and holding of drugs, the practices required for finished pharmaceuticals, biological products, and guidelines for electronic records and signatures.

    Elements of these CFR sections can be applied to such bio-pharma sectors as vaccines, prescription pills, and medicated creams. Deeper analysis and an understanding of such products and their sector-specific regulatory challenges can provide firms with the knowledge needed to take proactive, risk-reducing steps. Such steps, like purchasing an automated temperature monitoring device and recording service can mean the difference between good manufacturing practices and noncompliant ones.

    Next week we’ll continue our survey of CGMP with a good look at vaccines and their applicable CFR guidelines.

    Temperature@lert Free Monitoring Guide for Vaccines 

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  • Low-Cost Monitoring Systems for SMBs and the Cold Chain

    Can Small Hospitals and Bio/Pharma Labs Implement Affordable, Fault-Tolerant Cold Chain Monitoring and Alarming During Shipment of Organs, Tissues, IVs and Vaccines?

    Cellular technology combined with Cloud Computing may provide the answer.


    Above: Organ Shipment Container

    A recent article in the latest edition of Pharmaceutical Commerce (Link to article) titled “The Convergence of Environmental Condition Monitoring and Supply Chain Visibility” describes a robust system designed to provide visibility to the location and environmental conditions of temperature sensitive products during shipment and transit.  The system uses a combination of GPS technology with a 24/7/365 asset tracking service for pharmaceutical and biological materials companies worldwide. 

     

    Backed by a $60B technology conglomerate, this package certainly offers a high level of monitoring and security.  Still, what about the small and midsized Bio/Pharma labs, hospitals, and medical centers? What are their options for a robustenvironmental monitoring system for the cold chain, particularly if budgets cannot support the additional expenses from continuously staffed services?  In the end, cellular communication technology in combination with a cloud service may provide one answer. The cloud service will typically provide SMS text, email, and phone alert capabilities to complement the hardware.

     

    The use of monitoring systems for sensitive products (within the cold chain) is an established practice. Regulations have either been previously established, or are under current review/consideration. These regulations are tailored to geographic locations (US or International), and differ by application type (e.g: vaccines vs. organs for donation) The Pharmaceutical Commerce article outlines several of these quite well.  Aside from regulatory requirements, many makers of such materials have implemented or are considering risk management strategies and policies to insure product safety and efficacy.  Still, the challenge lies in the cost of implementation, wherein these strategies and policies (between the time the product leaves their shipping dock and the time it arrives and is received) can be tricky to follow.

    Above: H1N1 Vaccine Shipment

     

    Of course, shippers do their best to insure product and environmental integrity of their cargo, however, many have horror stories of compromised shipments or damaged materials. To that extent, compromised or damaged shipments lead to a loss of materials and valuable time, neither of which are ideal.  These items may even be the result of extensive testing, and these setbacks can disrupt the entire project/development.


    One solution would be to utilize the power of wireless cellular technology and a robust cloud computing data aggregation system. These cloud systems are most effective for collecting and analyzing sensor data.  The wireless cellular communication medium (along with long-lasting battery backups) can help insure that materials are monitored for the duration of the trip.  Such systems are highly sensitive in regard to environmental changes, and therefore insure that any deviations can be noted and flagged with an email, SMS text, or voice alert message. These messages are sent to one (or several) responsible individuals at any time.  Escalation plans can also be built into the system, such that the absence of any one “individual” is not a cause for failure. These plans ensure that if conditions continue to deviate from the norm, other individuals can be alerted through a priority-based alert system.

    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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  • Safe Vaccine Storage: 5 Point Checklist and Infographic

    Safe Vaccine Storage: 5 Point Checklist and Infographic

    There are many guidelines and suggestions based around vaccine storage, and while many are detailed and comprehensive, the value of a digestible explanation is wholly understated. Keeping it simple, or providing easy-to-read checklists, graphs, and guidelines instead of textbooked (and sometimes tired) prose, is quite effective for educating staff on proper guidelines and practices. The CDC typically does an excellent job of supplementing textbook-worthy explanations with "elementary" graphics and charts. Many of their own checklists (while also comprehensive) are easily digested and understood. To that end, Immunize.org also has an excellent .PDF checklist for safe vaccine storage and handling. These following 5 tips are extracted directly from their official checklist. To see the entire list, click here.




    1. Clean coils, bins, shelves, and other hard-to-reach spots in all refrigeration/freezer units every 3-6 months.

    2. Use calibrated thermometers with verifiable Certificates of traceability and Calibration (such as NIST) to ensure compliance.

    3. Ensure that all managerial personnel are well versed in CDC's storage and handling guidelines (wherever applicable)

    4. Purchase backup storage units and refrigerators (tied to internal batteries or generators) to safeguard against power outages. Switch to these secondary units when needed, and routinely check generators to ensure fault tolerance.

    5. Document the following details (manually or automatically via technology)

    • Vaccine type and quantity

    • Date received

    • Shipment condition (especially if damaged)

    • Manufacturer name

    • Expiration Date (keep an additional, separate log to compile expiration dates for extra precaution)

     

    We've also uncovered a very useful and informative vaccine storage infographic, courtesy of the Minnesota Department of Health


    Original Link: Minnesota Department of Health


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  • Data Loggers 2.0: Automation and Alerting

    Conventional data loggers have reached a critical evolution point, specific to the technology, software, and the availability of data that is provided. From the Wikipedia page on data loggers, we can see the evolution in the verbiage overlap.

    data logger (also datalogger or data recorder) is an electronic device that records data over time or in relation to location either with a built in instrument or sensor or via external instruments and sensors. Increasingly, but not entirely, they are based on a digital processor (or computer). They generally are small, battery powered, portable, and equipped with a microprocessor, internal memory for data storage, and sensors. Some data loggers interface with a personal computer and utilize software to activate the data logger and view and analyze the collected data, while others have a local interface device (keypad, LCD) and can be used as a stand-alone device.

    In truth, data loggers have been incredibly useful and reliable since their inception. Still, the current generation of data loggers has additional features that broaden the applications of the device, and in fact provide much higher value to consumers.

    One of the biggest drawbacks of a conventional data logger is the data recording process, which is typically done manually. As an example, a data logger unit may read temperatures safely and consistently while inside an oven, but the logger must be manually removed and connected to an external source in order to obtain the data. The process is thereby a two-step ordeal, in which extraction of data is not automated, and variances in temperatures (for the oven example) may only be discovered in retrospect. This means that by using data loggers to maintain records for auditing/health checks, the problem(s) or temperature changes may only surface after the data extraction/manual review. In the world of quality control, this hardly represents efficiency. In conclusion, while data loggers may be the most 'simple' solution for tracking temperature changes, the manual processes involved can quickly become cumbersome.

     


    On the other side, the current generation of data loggers has expanded on the utility and automation of the conventional options, and the result is a "Data Logger 2.0". In this new school of devices, the data loggers maintain the information in their location (like an oven), and transmit data through a variety of wireless channels, including WiFi and Cellular networks. The transmission of data cuts out the manual logging procedures, and brings automated reporting into the mix. Aside from the automatic reporting capabilities, continuous alerting is perhaps the biggest development in the evolution of data loggers. Conventional loggers could detect variances in temperature or moisture, but without an automated system or enabled software, could not provide alerting capabilities to proactive personnel. Continuous alerting has proved to be a critical development for temperature sensitive applications. Vaccine storage and food safety are two of the main beneficiaries of this technology, as the alerting procedures can prevent temperature variance in vaccines and bacterial infections from spoiled food. Both applications rely on timeliness to solve a potential problem, which is precisely the goal of continuous alerting. Furthermore, the cost savings that result from continuous alerting can tremendous, given the near-unlimited value of vaccines and/or stored food products. These continuous alerts may include text messages, emails, or even phone calls, and these represent an on-demand link between the user and the device (ideal for vaccines and food safety). Notifications ultimately inspire action, and timely action is the main goal for sensitive monitoring applications.


     Overall, the conventional process of 'manual data entry and evaluation' in data logging has been replaced by software systems that consolidate information (with intelligent logic) and deliver the information to the proper source.

    While there are still applications wherein a conventional data logger is still useful, it's mostly been segmented into low-sensitivity applications that don't require continuous alerting, automatic reporting, and/or automatic data transmission. The tedious process of manual data entry, as stated, is not efficient for many businesses that require timely data reports and the notification of critical changes/events. However, the "new school" of data loggers is fully automated, allows transmission of information through conventional networks, and provides real-time alerting features that were absent from conventional devices.  When considering a continuous alerting device or data logger, remember that the differences are typically seen in automation techniques and alerting functionality. 

     

     

     



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  • DTaP and Vaccine Safety: A Message from Harry Schechter

    A Note from Harry Schechter:

     

    If you're like me, you're a parent hoping to stretch the limits of time. It's a 24 hour day nonetheless, and sometimes, even as close as I am to this business, I lose sight of what's really important. I was speaking with our marketing department about this upcoming blog series about vaccines, vaccine storage tips, and directed guidance for handling of a variety of life-changing vaccines.  We were preparing to talk about DTaP (Diphtheria, Tetanus, Pertussis), and the acronym brought me to a catharsis of sorts.

     

    Before I had children, I had been relatively clueless about the shots that I had received in the past, and frankly, a bit paranoid as I had received many vaccinations before the advent of many handling and storage standards (or at least, the standards that I see today). My son is 5 years old, and it was only two weeks ago that he was given the DTaP vaccine from his doctor. I was hoping to ask a question unrelated to the vaccine and about his general health. My son, meanwhile, was temporarily engrossed in action figure acrobatics and was anticipating a lollipop.

     

    When I was talking to the doctor, I didn't feel obligated to go that extra mile to ensure that my son, among others, was receiving a vaccine that had been properly stored (within temperature range), handled carefully prior to use, and had not 'expired'. I took one look at the syringe and thought nothing of it.

     

    On the drive home, I was thinking about how relaxed I felt (as well as my son, surprisingly!) about the vaccination. I thought about some of the news stories that I had read, from meningitis outbreaks to tainted vaccines, and after hearing about the DTaP blog topic, I realized that I needed to say something.

     

    For my son's next visit, I may not be able to walk into the storage units myself to check quality control, but I will make a push to understand their practices and standards regarding vaccine storage. I remembered a commercial which showed a man at a restaurant who asked endless questions about menu items. The same man was put into a doctor's office, and he remained silent when posed with "did you have any questions or concerns?". Don't let this be you, especially if your children are the issue.

     

    I hope these thoughts reach you well.

     

    Sincerely,

     

    Harry Schechter

    CEO at Temperature@lert

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  • Vaccine Storage Series: 3 Basic Handling Practices and Routines

    vaccine storage

    Vaccine Storage Series: Standard Practices and Routines

    There have been many CDC.gov alerts and updates for a range of issues in the past year. A quick visit to the CDC.gov website brings a flurry of information and data, which for some of us, can be difficult to sort through. There are routine revisions to "best practice" guides, all of which must be instituted in a timely fashion. For your convenience, Temperature@lert will be condensing a series of handling practices and routines for a variety of specified vaccines. This series will begin with a "beginners" guide to address basic storage and handling of vaccines, and will move deeper into specific instructions for Haemophilus influenzae type b, Human Papillomavius (HPV), and other common vaccines in the coming weeks. Of course, this will also include tips for temperature monitoring, temperature sensors, and the general topic of 'temperature' as it relates to vaccine storage.

     

    We do typically speak of 'temperature monitoring' as an important factor to consider for vaccine storage, but in truth, this only represents one piece of the 'best practice' puzzle. Progressive and responsive adherance to all CDC requirements is extremely important for vaccination storage. As always, please refer to the CDC.gov website for full and official documentation of these sensitive practices. 

     

    Purchase and Arrival:

    • When purchasing vaccines, note the date of delivery and be sure that staff members will be available (specific time and date) to recieve the vaccines.

    • Anticipation of need: Note the times that vaccines may be in higher demand. Make sure to stock a surplus of vaccines for these time periods, and collaborate with your supplier about time-sensitive order increases. Anticipate the need, and fulfill as neccesary.

    • Ideally, vaccines should be stored (whether frozen or refrigerated) as soon as possible after delivery. Lost time can compromise the effectiveness and/or potency of the vaccine(s). 

    • Logged data = organized operation: Keep an informative log of vaccine inventory: Include vaccine type, quantity of doses, date recieved, arrival condition, manufacturer infromation, and most importantly, the expiration date .For extra safety, mark the expiration dates in red to highlight the definitive "cut-off" date for usage, and mark in a vaccine-specific calender as neccesary.

    Storage and Handling:

    • Size Matters: Ensure that your refrigerator and freezer units are properly sized to handle the quantity of vaccines that you may order, and note that temperatures may vary between units. Utilize a temperature monitoring device to guarentee temperature accuracy for these storage units, and never "stuff" a unit to offset inadequate storage capability elsewhere.

    • Division:  Divide all vaccines by type, and store them together appropriately. When possible, avoid 'uniting' different vaccines under the same storage roof, and never store consumables (food, drinks, yesterday's lunch) within vaccine-dedicated units. The seperation will improve your organization, contrasted with the 'all-vaccine-inclusive storage unit' that can easily become cluttered and may compromise the vaccines due to a variety of variables (air circulation, etc).

    • NIST Certification: For all thermometers and temperature sensors, NIST certification sheets should be alongside their noted devices, and should be displayed clearly. Highlight the certificate's expiration date in red for easy reference on renewal.

    • Temperature Tracking: If you use a temperature monitoring device, ensure that the device is transmitting temperature readings twice daily. If using manual logs, use extra caution in logging all temperatures, and keep explicit rules (time, person, method) for your data. As per the CDC, historical logs should be kept for 3 years at a minimum. 

    • General Vaccine Placement: Never store vacines on the door of the unit, and allow air circulation between vaccines. Keep vaccines away from all walls and vents, as these areas show signiciant temperature variation.Check out our blog post on the differences in temperature within refrigeration/freezer units for more detailed information on this issue.

    Management:

    • Priority Matters: Give priority to vaccines that have an upcoming expiration date. Keep a simple rotation that defines the "next" usable vaccine as the one with the most imminent expiration date. Make sure to remove any expired vaccines from this rotation immediately.

    • Organize and Inspect: Make it easy on your staff by marking specified areas for specific vaccines within the storage units. Establish routine 'areas' for storage, and mark potential 'pain points' within the unit. If there are any noticable changes or unfamiliar markings, consult with your staff to uncover the reason for any irregularities. Inspect storage units on a daily basis and keep close watch for equipment malfunction and/or temperature variation. 

    • Contaminated Vaccines: If vaccines have expired or have been potentially compromise, immediately label them with a bolded 'DO NOT USE' sticker. Keep these away from all usable vaccines in a seperate storage and maintain the appropriate temperature conditions. Follow all state-mandated procedures for disposal of the contaminated vaccines, and don't forget to educate your staff. 


      All of these tips and procedures are great when posted on a company bulletin board, but this is no substitute for adequate training. Employees must be capable, sensitive to the specific rules and guidelines, and should always follow the stated procedures without any type of 'ad-lib' or improvisation. If confusion still arises, hold an in-depth meeting to work on clarity and efficiency regarding the procedures and routines. Preparation is key, but implementation and adherance by your staff is just as important. Stay tuned for vaccine-specific advice in the coming weeks, and keep a sharp eye for any CDC.gov updates specific to your needs. We'll do our best to keep up with the changes, and we'll update this series to keep you informed.


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  • Vaccine Retrieval and Storage: Power Outages

    For most of us, a power outage is a sudden and temporary inconvenience that leaves us without our beloved gadgets and internet (that is, until the battery in your iPhone dies). But for vaccine storage, it's clear that a power outage brings larger and more troublesome obstacles. 

    It is virtually unavoidable to prevent all power failures. Storage faciilities must have back-up plans and back-up equipment to prepare for a power outage. Courtesy of the CDC's latest toolkit, here are a few procedures that you should be implementing in your power outage solution.

     

    1. Do not allow vaccines to remain in a nonfunctioning unit for an extended period of time, if you cannot forsee an immediate 'uptime' for the facility. 

    A homeowner might know this one instinctively; a power outage that lasts several hours can compromise the food in a home refrigerator/freezer. Though the food may be able to sustain an hour or two without cooling, it will eventually become a breeding ground for bacteria. Vaccines, on the other hand, are only effective when the temperature is kept within the required range. Avoid this by moving vaccines into emergency/secondary storage units as soon as possible after an outage.

    Generally, for attenuated vaccines (of which contain a weakened form of the actual virus), exposure to heat and light can compromise the contents. Be sure to move these vaccines to cooler zones immediately during a power outage. On the opposite side, inactivated vaccines are sensitive to freezing temperatures. However, it is difficult to determine whether inactived vaccines are frozen/affected by variable temperatures, and a simple "eye test" is never sufficient. Stay tuned for next weeks post on the differences between attenuated and inactivated vaccines.

     

     

    2. If you are certain that power will be restored before comprimising temperatures can settle in, continue to use caution and be safe, not sorry.

    Do NOT open a storage unit door until the power has been completely restored. Even if the outage is temporary, make sure to avoid exposing vaccines to uncontrolled and uncertain temperatures. Vaccine storage is really a calculated science, and the environment outside of the storage unit represents uncertainty, fluctuation, and variation (not helpful). Whereas on the inside, the temperature and climate are controlled, certain, and show very little fluctuation (ideal for vaccines). In an outage, keep vaccines in their proper dwelling, and be sure not to disturb the natural (and controlled) temperature within the units.

     

    3. Once power is restored:

     Check all refrigerators and freezers that have been affected by the loss of power. make sure to to mark storage units that have moved beyond their set thresholds (Refrigerator 2C-8C , Freezer -50C and -15C). Document the changes in temperature from the thresholds, and make sure to indicate how long vaccines were out of their required range. Such information is highly useful for disaster recovery plans, and can provide insight for future outages. If you ever have  suspicions about a vaccine(s) after a power outage, be sure to mark these with a "DO NOT USE" label and store them seperately. The key is to isolate the affected vaccines, and ensure that they're handled carefully after a power outage. With thorough planning, robust procedures, and attention to detail, affected vaccines can be recovered and bacterial growth can be averted afrer power outages.

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  • 3 Industries for NIST Sensor Certification

    No two temperature sensors are alike. In the Temperature@lert "lab", we undertake a series of rigorous testing and research for our products, ensuring their accuracy and responsiveness. Still, an average 'sensor' is not properly certified for sensitive temperature applications. Legislative guidlines are often strict for these use cases, and ultimately require specific certifications. The National Institute of Standards and Technology (NIST) is the temperature monitor 'go-to' source for certification. But what exactly is a NIST certification, and why is obtaining one important?

    Example Certificate: NIST from Temperature@lert

    In short, NIST is the National Measurement Institute for the United States. They provide regulatory, certification, and conformity assessment information for 'standards-related' activities. By using Standard Reference Materials (SRMs) NIST testing confirms the accuracy of specific measurements. These standard materials represent the 'baseline' of standards, and the certification is then based on conformity to the baseline.

     

    For many industries, the NIST certification is seen as the 'holy grail' of accuracy and is important as an 'advanced monitoring technique'. Check out these industry-specific tips for NIST certification, and see if you need a certification!

     

    IT/Server Room Industry: (Low Concern)

    Currently, accuracy within 1-2 degrees is sufficient for NIST certified devices in server rooms. The devices should accurately measure rising temperatures in your server rooms, as overheating can lead to a typical 'IT disaster'.

     

    Food Distribution (includes Wine Cellers): (Higher Concern)

    Ensuring the accuracy of sensors is highly critical for food distributors. Spoiled food and bacteria can cause health problems for consumers and financial headaches for their companies. All sensors must be NIST calibrated to display the proper measurement of food temperatures. With the proper measurements, one can prevent spoilage or bacterial buildup. 

     

    Vaccine Storage(Highest Concern)

    NIST certifications are the most applicable for temperature monitoring devices used for vaccine storage. Calibration needs to be extremely precise, as sensors should be within 0.5C or better. In most cases, NIST certification is required by law and is not a flexible process.

     


    Get Certified with Temperature@lert today!

    Temperature@lert offers NIST certified temperature probes for our USB, WiFi and Cellular Edition product lines. 

    The certificate includes several temperature test points, and also specifies the serial number of the probe. Please call or email us for further information on how to obtain NIST traceable pre-certification of your Temperature Alert sensors.

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