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For more information, please contact: 6 Warner Rd. Warner, NH 03278 (603) 456-2011 [email protected] According the World Health Organization (WHO), the pharmaceutical industry generates hundreds of billions of dollars each year. Along with the large revenue comes strict requirements for regulations, rules and compliance. The list of critical factors is long, but a few rise to the top for facility managers to be aware of, specifically those issues related to temperature monitoring. General Climate Control One important factor for the pharma industry is general climate control. Most companies must have continuous monitoring in place to ensure building temperatures are appropriate for product integrity. Most pharmaceuticals should be kept between 15 °C- 25 °C, certain conditions and products may allow for the temperature to be set at 30°C. Data Loss Prevention The WHO states that wireless systems must be able to continuously collect data even during power outages and network failure. MadgeTech wireless data loggers offer real time data transmission from the device to a central computer and to the MadgeTech Cloud for remote instant access. In the event of a power outage or communications disruption, the data loggers will continue recording and saving the data to the internal memory of the device. All buffered data will transmit and download to the central PC when the network is restored. Pharmaceutical Storage Storage for pharmaceuticals is not easy, and the products being created or handled are extremely sensitive to storage temperature deviation. This is an important and sizable investment for pharmaceutical companies. Dedicated storage facilities can cost millions to construct, with the ongoing maintenance cost adding to this. If an HVAC unit were to fail in any hospital or storage facility, the potential spoiling of goods could cost the facility thousands of dollars. Exposure to improper temperatures, even for a short period of time could render pharmaceuticals useless and potentially harmful for patients. Vaccine storage is an example where there is little room for error in this regard. WHO has very strict standards set when it comes to the storage of pharmaceuticals, because they are not something you can store in any basement or closet, you must consider the needs of the specific pharmaceuticals. To address the monitoring needs for each scenario, MadgeTech data loggers come equipped with user configurable alarms and notifications. When any specified threshold is exceeded an alert can be sent by text or email to the desired recipient. This feature is extremely valuable, allowing the user to act quickly and correct the situation to head off product damage or spoilage. Ultra-Low Freezer Validation Some pharmaceuticals must be stored being below freezing temperatures. Typically, freezers are monitored with data loggers and that data is used to create reports to verify that consistent and appropriate temperatures were maintained. MadgeTech offers an all in one solution for this application, the ULT90-9 data logging system. This system includes 9 Cryo- Temp Ultra Low Temperature Data Loggers that can measure temperatures as low as -86°C. The ULT90-9 also comes with the IFC300 USB docking station to connect the loggers to a PC for configuration and data retrieval. This kit is bundled with the MadgeTech Secure Data Logger Software which offers advanced data analysis and reporting tools, along with IQOQPQ guidelines and workbook. This is ideal for simplifying compliance needs for pharmaceutical professionals. Maintenance of Monitoring Devices The WHO requires that all loggers are able to register accurate temperatures deviations of .05°C or less. This is where regular and responsible data logger maintenance pays off. Data loggers are extremely accurate and are designed to weather the exposure of intended environments, however, if the devices are not calibrated, results will start to drift over time. Calibration frequency depends largely upon how and where the device is used. With average use, MadgeTech recommends annual calibrations of all data loggers. If the device usage is constant or very high or if the device is exposed to extreme temperatures, increases calibration frequency is necessary. MadgeTech offers a wide variety of data loggers for pharmaceutical needs, including device options with wireless capabilities, and ultra-low or high temperature sensors. The MadgeTech product line combined with the powerful features of the MadgeTech Data Logger Software simplify the entire process, from monitoring and logging to downloading, analyzing and reporting for all pharmaceutical temperature critical applications.

Top five pharma temperature concerns

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For more information, please contact:

6 Warner Rd.

Warner, NH 03278

(603) 456-2011

[email protected]

According the World Health Organization (WHO), the pharmaceutical

industry generates hundreds of billions of dollars each year. Along with

the large revenue comes strict requirements for regulations, rules and

compliance. The list of critical factors is long, but a few rise to the top for

facility managers to be aware of, specifically those issues related to

temperature monitoring.

General Climate Control

One important factor for the pharma industry is general climate control. Most companies must have continuous monitoring

in place to ensure building temperatures are appropriate for product integrity. Most pharmaceuticals should be kept between 15 °C- 25 °C, certain conditions and products may allow for the temperature to be set at 30°C.

Data Loss Prevention

The WHO states that wireless systems must be able to continuously collect data even during power outages and network

failure. MadgeTech wireless data loggers offer real time data transmission from the device to a central computer and to the

MadgeTech Cloud for remote instant access. In the event of a power outage or communications disruption, the data loggers

will continue recording and saving the data to the internal memory of the device. All buffered data will transmit and

download to the central PC when the network is restored.

Pharmaceutical Storage

Storage for pharmaceuticals is not easy, and the products being created or handled are extremely sensitive to storage

temperature deviation. This is an important and sizable investment for pharmaceutical companies. Dedicated storage facilities can cost millions to construct, with the ongoing maintenance cost adding to this.

If an HVAC unit were to fail in any hospital or storage facility, the potential spoiling of goods could cost the facility thousands

of dollars. Exposure to improper temperatures, even for a short period of time could render pharmaceuticals useless and potentially harmful for patients. Vaccine storage is an example where there is little room for error in this regard.

WHO has very strict standards set when it comes to the storage of pharmaceuticals, because they are not something you can

store in any basement or closet, you must consider the needs of the specific pharmaceuticals. To address the monitoring

needs for each scenario, MadgeTech data loggers come equipped with user configurable alarms and notifications. When any

specified threshold is exceeded an alert can be sent by text or email to the desired recipient. This feature is extremely valuable, allowing the user to act quickly and correct the situation to head off product damage or spoilage.

Ultra-Low Freezer Validation

Some pharmaceuticals must be stored being below freezing temperatures. Typically, freezers are monitored with data loggers and that data is used to create reports to verify that consistent and appropriate temperatures were maintained.

MadgeTech offers an all in one solution for this application, the ULT90-9 data logging system. This system includes 9 Cryo-

Temp Ultra Low Temperature Data Loggers that can measure temperatures as low as -86°C. The ULT90-9 also comes with

the IFC300 USB docking station to connect the loggers to a PC for configuration and data retrieval. This kit is bundled with

the MadgeTech Secure Data Logger Software which offers advanced data analysis and reporting tools, along with IQOQPQ

guidelines and workbook. This is ideal for simplifying compliance needs for pharmaceutical professionals.

Maintenance of Monitoring Devices

The WHO requires that all loggers are able to register accurate temperatures deviations of .05°C or less. This is where regular

and responsible data logger maintenance pays off. Data loggers are extremely accurate and are designed to weather the exposure of intended environments, however, if the devices are not calibrated, results will start to drift over time.

Calibration frequency depends largely upon how and where the device is used. With average use, MadgeTech recommends

annual calibrations of all data loggers. If the device usage is constant or very high or if the device is exposed to extreme temperatures, increases calibration frequency is necessary.

MadgeTech offers a wide variety of data loggers for pharmaceutical needs, including device options with wireless

capabilities, and ultra-low or high temperature sensors. The MadgeTech product line combined with the powerful features of

the MadgeTech Data Logger Software simplify the entire process, from monitoring and logging to downloading, analyzing

and reporting for all pharmaceutical temperature critical applications.