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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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  • HACCP Inspections: Active Managerial Control

    The FDA’s stance on Active Managerial Control

    More now than ever, the active communities of review and ranking sites have provided a clearer window into restaurants and food establishments, and needless to say, this transparency and honest feedback is invaluable to owners and consumers alike. With that said, restaurant owners and operators are also tightening their in-house food safety practices to prevent spoilage and bacterial infestation. In the larger picture, these practices reflect well on the operational capability of the establishment, and also serve to prevent the stigmata of food inspection violations. 

    The FDA has long published documentation on prevention and adherence to the HACCP (Hazard Analysis and Critical Control Points) preventative approach for food service. Still, many restaurant owners and operators are unaware or unfamiliar with these practices and suggestions, and to this day, health inspectors are suspending licenses and punishing these businesses for failing to comply. While reviews and consumer feedback are invaluable to the welfare of a restaurant or food establishments, these inspections are not to be overlooked or ignored. The following explication of active managerial control serves to inform you about the basics of HACCP, and what you should expect from a visit with the health inspector.

    Temperature@lert HACCP Food Safety Monitoring

    One of the primary objectives of a health inspector is to observe the level of active managerial control, or as the FDA defines “the purposeful incorporation of specific actions or procedures by industry management into the operation of their business to attain control over foodborne illness risk factors.” In short, such actions and procedures are a preventative and proactive approach to food safety, as opposed to reactive post-disaster tactics. Following this approach is critical for any food establishment or restaurant to ensure best practices in the kitchen. The above statement specifically cites foodborne illness risk factors, of which are outlined below.

    • - Food from Unsafe Sources (farms, meatpacking plants, etc)
    • - Inadequate Cooking (to subpar temperatures)
    • - Improper Holding Temperatures
    • - Contaminated Equipment (bacteria, mold, dust, etc.)
    • - Poor Personal Hygiene (for line cooks, chefs, and prep personnel)

    The health inspector will be focusing on these five points of failure as they represent the most sensitive areas for food safety and food consumer protection. There are a number of tactics that can be used to avoid these risk factors, and while some dwell in the neighborhood of common sense, others are not so obvious. The following food safety management tips are taken directly from the Regulator’s Manual for Applying HACCP Principles to Risk-based Retail and Food Service Inspections. Consider this a quick ‘cheatsheet’ for your next inspection, and be sure to employ as many of these smaller strategies to conquer the larger goal of safe food practices. These represent FDA-approved guidelines for HACCP compliance.

    • - Standard Operating Procedures for critical operational steps in a food preparation process. This includes cooling, heating, reheating, and holding.
    • - Recipe Cards or ‘cheatsheets’ that contain specifics steps for individual item preparation. This should include important boundaries such as final cooking temperature, verification, and directives for temporary storage.
    • - Monitoring procedures for preventing bacterial growth, spoilage, and proper cooking/holding temperatures.
    • - Record keeping. These include temperature records, employee records, and equipment maintenance and upkeep documentation.
    • - Health policy for restricting ill employees from the establishment.
    • - Specific goal-oriented plans, such as Risk Control Plans (RCPs) that are used to control specific and more incremental risk factors.

    In the next piece, we’ll dive further into these incremental risk factors and RCPs that can easily be employed in your restaurant or food establishment. Remember that while the world of online reviews can boost your consumer reputation, the food safety management suggestions from above are equally as important for the long-term livelihood of your business.

    Temperature@lert HACCP Food Safety Monitoring

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  • We Have Launched a Full Services Arm

    After creating an extensive line of environmental monitoring devices for a range of conditions (including humidity, flood, and soil moisture), the services arm expands our ability to assist clients who require more than the “out-of-the-box” solution. Our services arm specifically includes nationwide installation, customized software & sensor development, private labeling / OEM, and verification/validation services.
     
    The expansion of our offerings is critical to Temperature@lert's development. Enterprise clients are often seeking a fully-fledged, customized solution for industry-specific applications, in line with the development and advancement of our remotetemperature monitoring devices. From implementation of a fault-tolerant solution for IT server rooms, to pharmaceutical refrigerators and food service kitchens; our services arm can meet the needs of Enterprise clients that require installation, customization, private labeling, and meeting compliance regulations.

    “Temperature@lert products are the easiest to use for out of the box environmental monitoring. We're confident you'll be up and running in no time,” states Harry Schechter, CEO/President of Temperature@lert. “However, there are times when you run up against a challenge and need just a bit more out of your investment. With the modular and open nature of our products, we believe there's always a way to customize or engineer new solutions to fit your exact specifications. With this belief is how our services arm was launched.“
     
    For more information on Temperature@lert’s latest service offerings, please visit:http://www.temperaturealert.com/Remote-Temperature/Services.aspx.

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  • Is Your Food in the Danger Zone?

    When dealing with food safety, it is crucial to remember that temperature variations can mean the safety and well-being of your diner. Although, many would not like to think so grimly about how changes in time and temperature affect your food so severely; these changes can most certainly gravely impact your diner's health. Food safety should always be a top priority and concern for anyone in food service.

    All foods should be maintained at certain temperatures; however, many foods still fall into the Danger Zone. The Danger Zone is known as the range of temperatures between 40°F to 140°F. This range of temperatures is most dangerous because it is within this range that germs and bacteria grow the fastest. Bacteria can double in growth within 20 minutes of being in the Danger Zone, especially if it's a moist environment. Once food falls into the Danger Zone, there is no way to kill off the germs in order to make the food safe enough to consume. Best practice would be to avoid the danger zone all together and follow theses guidelines:

    • -Keep hot cooked foods at or above 140 °F. Hot foods should be placed in preheated steam tables, warming trays, or slow cookers if the hot food is not being immediately served

    • -Keep cold foods at or below 40 °F. Food should be placed in containers on ice if not in refrigeration units.

    • -Cool leftovers using a blast-chiller, otherwise placing them into food pans and back into the refrigerator/freezer would work.

    • -Leftovers should be placed in shallow pans for quicker cooling.

    • -Leftovers should be placed into the refrigerator/freezer (<40°F) within 2 hours to prevent spoilage of perishable foods.

    • -Never leave food out of the refrigerator for more than 2 hours, and no more than an hour on a hot day (90°F+).

    • -Cooked foods must reach the minimum safe internal temperature for at least 15 seconds in order to be deemed safe for consumption.

    • -Reheated foods need to reach 165°F (hot & steaming) in order to be safe for consumption.

    • -When roasting meat and poultry, the oven temperature can be no lower than 325°F.

    • -Use a meat thermometer whenever possible to make sure that the internal temperature of your specific meat is being reached.

    • -Monitor temeprature of food prep areas if necessary to make sure your prepared ingredients don't spoil.

    Whether you're cooking, reheating, cooling, storing, or whatever you are doing with your food; it is important to remember the safety of your diner. Although a diner may not perish like your perishable food from bacteria, your diner can still get severely ill. It may seem to be a bit over-whelming to monitor all these various temperatures, but you can be sure that this will avoid a health violation and that your diner is happy to be served delicious, bacteria-free food from your establishment.

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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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  • Is Your Food Ripe for Bacterial Growth?

    Refrigerators, freezers, steam tables, and food prep areas are all known sources of bacterial growth when proper temperatures are not maintained. Of course there are paper logs and thermometers that you can place in these areas, but what happens when that person who is supposed to be monitoring is absent, or if the thermometer malfunctions? Who ismonitoring the system for monitoring?

    When a temperature monitoring system is not fault tolerant, this leaves food and beverages dependent on proper temperature storage extremely vulnerable for bacterial growth. Cooking food at the proper temperature is not the only determinant for killing bacteria. Even after food is cooked for prep, they are stored in a food prep area such assteam trays that must be maintained at 150°F in order to prevent bacterial growth. Salmonella, E. coli, and Listeria are some of the bacteria that can grow when cooked food drops below 135°F.

    For cold food storage, the maximum temperature is 41°F. Anything above this can cause bacteria growth. Failure to store food within temperature thresholds is a critical health violation found in many restaurants, cafeterias, and other areas for food service when proper temperature monitoring procedures are not followed.

    Although temperature monitoring is frequently overlooked, we cannot overlook the effects caused by lack of monitoring.Besides spoilage and contamination, there are the health effects such as gastrointestinal symptoms, vomiting, GI issues, and diarrhea. A single strand of bacterium can cause such stomach upset, due to the fact that no one is monitoring the monitoring system. This is when a fault-tolerant system comes in handy!

    Fault-tolerant systems would be able to alert you of temperature issues before one arises. Not to mention, it would alleviate the pressure of frequently checking temperatures when one does not have the timeLearn more about proper food storage from our FREE Cheat Sheet in Food Service Monitoring!

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  • It's Hot! It's Cold! Oh No... It's Your Fluctuating Server Room Temperature Again...

    We know that every room, especially a server room, has its own microclimate. Even sensors that are inches apart can read different values! Although similar applications might share the same temperature threshold range, every sensor placement location is unique. It sounds strange; that there would be such fluctuations in temperature within inches, but this happens because your server room has its own minature weather pattern!

    So how do you figure out the correct temperature range for monitoring your server room? Or where to place your sensor? As many conditions as there are for the actual ourdoor weather patterns, there are many variables for sensor placement and operational range because of the changing indoor microclimate.

    Essentially, in order to determine the right thresholds for your server room "environment", you need to acquire adequate baseline knowledge. This process is called "baselining", which involves monitoring your server room first to establish a history of normal conditions. Temperature is a significant threat to your equipment and in order to battle this, you need to discover and establish your server room's microclimate (i.e. baselining)!


    Baselining is basically achieved through studying the space of your server room while considering the components within it. Thic can be done to determine the proper ranges for both temperature and humiditySo what spots are the most critical for consideration when it comes to sensor placement?

    1. Hot Spots
    At the bare minimum, place at least one sensor in a central location in the room. Note: every room has its own mini weather pattern, and conditions from one part to another can vary based on what the room contains and where vents/returns are located. The simplest rule of thumb is that heat rises. So, the higher the sensor placement, the warmer the temperature

    2. Cooling Vent Locations
    Whether it is an air conditioner, economized cooler, or another chilling device, it will affect the sensor reading depending on proximity of the sensor to the vent. If you want to monitor whether your cooling unit may be going out at different times,place a sensor in the air duct and you can determine when the cooling unit is off. Placement of a sensor in close proximity to the cooling unit may cause the sensor to pick up cooling unit "cycles", sending you false alerts in the process.

    3. Exhausts
    Besides cooling vents, you need to also consider hot vents from server cabinets or compressors. Placing a sensor near or in between these areas is crucial as high temperatures can cause damage to hardware. The exhaust-based alerts will draw attention to the high temperatures within the servers, allowing you to prevent loss of hardware (and revenue!)

    4. Ancillary Humidification Systems
    These systems help control humidity. Too much humidity can cause condensation, which leads to electrical shorts. Not enough humidity causes one to have quite the mini-electrifying experience with static electricity at its peak. Place your humidity sensor in a location seperate from the ancillary humidification system in order to prevent the sensor from getting shorted and to avoid false humidity readings.

    By monitoring temperature and humidity, one can have early warning of any disasters looming in your server room. It is always better to prevent a disaster rather than mop up after it (speaking of, flood sensors are great too!). If you need assistance in determining the best practices and routines for your server room, please feel free to shoot me an email:diane@temperaturealert.com.

    Happy Monitoring!

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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? 

     

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    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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  • The Concerning Environmental Conditions in Your Server Room

    Scorching temperatures, flooding, and humid conditions all come together to form the perfect storm. However, this doesn't occur in just nature. This can also occur in your server room! Servers are expensive pieces of equipment and the last thing you want to have is a server meltdown.

    Last week we discussed how temperature plays a significant factor in maintaining the lifespan of your server. When monitoring your server room, you need to be aware of the various conditions from temperature to humidity to flooding. Reason being that any of these environmental hazards can seriously damage your servers.

    Power outages, air conditioner failures, water leaks, or high humidity can cause an array of problems. Together, these conditions can shutdown or even melt server room equipment. Flooding and high humidity can cause electrical shorts as well.

    Air conditioners and cooling units are neccesary to prevent your server room temperatures from reaching scorching temperatures. Nevertheless, power failure can happen to anyone. When the power fails, the cooling units stop cooling. Without fully-operational cooling units, server temperatures can reach catastrophic extremes. According to ASHRAE, you have about 15 minutes before a temperature problem arises, mostly due to the high rate of change. In summary, Proper cooling systems, air conditioning units, and solid monitoring practices are important for any server room.

    Tune in next week to learn more about how to effectively monitor your server room or learn more now from our free E-Book.

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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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