For more information, please contact:

6 Warner Rd.

Warner, NH 03278 (603) 456-2011

info@madgetech.com

Data Loggers Used to Map Environmentally

Controlled Areas for Pharmaceuticals

The United States Pharmacopoeia Convention (USP) is a nonprofit

organization that sets standards for human and veterinary drugs, dietary

supplements, and certain food ingredients. Although the strict guidelines

published by USP are not regulated by the organization itself, they are

enforceable by the United States FDA and are used in over 140

international counties.

ONE CHAPTER THAT HIGHLIGHTS THE BEST PRACTICES AND PRINCIPLES PUT

OUT BY USP IS CHAPTER 1083, GOOD DISTRIBUTION PRACTICES (GDP). THIS

CHAPTER IS DIVIDED INTO FOUR SUB-CHAPTERS, ONE OF WHICH, 1083.2,

FOCUSES COMPLETELY ON ENVIRONMENTAL CONDITIONS MANAGEMENT. IN

ORDER TO REMAIN IN COMPLIANCE, COMPANIES MUST BE ABLE TO

DEMONSTRATE A LEVEL OF CONTROL THAT THEY HAVE OVER THE

ENVIRONMENTS THAT THE PHARMACEUTICALS ARE SUBJECTED TO.

THE TWO MAIN ENVIRONMENTS THAT MUST BE MONITORED AND TIGHTLY

CONTROLLED OCCUR DURING THE STORAGE AND SHIPPING OF THE PRODUCTS.

IN ORDER TO ADHERE TO REGULATIONS AND ENSURE THE SAFETY OF

PHARMACEUTICALS BEING RELEASED TO THE PUBLIC, MAPPING STUDIES MUST

BE DONE IN BOTH SHIPPING ENVIRONMENTS AND STORAGE FACILITIES.

For more information, please contact:

6 Warner Rd.

Warner, NH 03278 (603) 456-2011

info@madgetech.com

Data Loggers Used to Map Environmentally

Controlled Areas for Pharmaceuticals

MAPPING The mapping process creates a detailed overview and record of the environment, including temperature and humidity levels, which the product will be exposed to. This provides the ability to better prepare for and recognize fluctuations that may occur and compromise the contents. The most effective way to perform a mapping study is by using data loggers to establish a temperature profile of the room. Because of natural occurrences in buildings such as cooling coils, heaters, windows and doors, temperature and humidity levels can vary. These areas should be noted and addressed so that products will not be compromised. The temperature profile should also include the mean kinetic temperature (MKT) of various areas in the storage or shipping facility.

When mapping the facility to be used for storage, MadgeTech wireless data loggers offer a reliable and flexible

solution to monitor and record temperature and humidity levels in warehouses and other storage facilities. These data loggers can measure multiple parameters and can transmit data wirelessly back to a central PC to be viewed in real-time. Additionally, all MadgeTech Wireless data loggers can be configured to utilize MadgeTech Cloud Services, making data instantly visible and accessible from any internet enabled device for authorized users. Using the MadgeTech Data Logger Software, results can easily be displayed on the screen, and calculations (such as the mean kinetic temperature) can automatically be computed.

CONTINUOUS MONITORING As outside weather changes, it is unrealistic to believe that internal temperature and humidity levels will remain the same from day to day. Although mapping provides a thorough temperature profile, giving a clear overview of the area that the products are being stored, ongoing monitoring is important and necessary for product safety. Monitoring and recording throughout the actual storage and shipment of each load, provides the record and notification of any fluctuation that does occur so that appropriate action can be taken to keep the pharmaceuticals safe.

With the release of MadgeTech Cloud Services, continuous monitoring becomes as simple as checking a mobile

phone. Now, wireless data loggers can be easily connected to the cloud to make data available in real time from any internet enabled device. This means that regardless of location, managers can stay up to date on the current conditions in any storage facility, or multiple storage areas around the globe.

MadgeTech also offers stand-alone data loggers designed specifically to travel with the product and monitoring shipping. This series of data loggers are small enough to fit easily in with shipments and track the environmental exposure for the entire shipment process. MadgeTech has a variety of data logger options to best suit specific product needs. For example, the Cryo-Temp data logger is compact and ideal for monitoring cryogenic material

during shipping. The Cryo-Temp data loggers can operate in temperatures as low as -86 °C, which accommodates certain pharmaceuticals and products that must consistently maintain and be stored in ultra-low temperatures.

For pharmaceuticals that do not need to be kept at such low temperatures, there is the TransiTemp series of data

loggers. These splash proof, compact, affordable devices can measure between -20 °C and 70 °C and are available with humidity monitoring capabilities as well.

DATA LOGGERS Although the regulations that are mandated require strict procedures and processes, they are in place to assure that safe pharmaceuticals are distributed to the public. Fortunately, data loggers help streamline the required processes and simplify the tasks for everyone involved in the storage and distribution of pharmaceuticals.