Considerations of Temperature Mapping and Datalogging for GMP-Regulated Products

On August 20th 2014, the ISPE LA/OC APICS joint meeting was held, covering Considerations of Temperature Mapping and Datalogging for GMP-Regulated Products.

Jason Daoust of Masy Systems discussed validation dataloggers, including their trends, considerations, and options in use today.

He presented an overview of how environmental mapping equipment has evolved and how the industry acceptance of validation dataloggers has increased significantly in recent years. Even though no perfect validation datalogger exists today, most major and minor companies are realizing their benefits. There is a wide variety of loggers for specific applications such as temperature ranges and probe types, and each system has trade-offs. Standalone validation dataloggers vary in temperature ranges (anywhere from -200C to 400C+), humidity ranges (typically anywhere from 0% to 95%), pressure (typically 0 to 72.5 psia) and time.

Mr. Daoust defined validation dataloggers as self-contained, with the ability to store data locally, operate independently, and be individually calibrated. He highlighted some of the benefits of using validation dataloggers, one of which is their lack of wires, which saves a lot of time and effort. They also have a quicker set up time, as they are “program and go”, making them great for large and small spaces alike. Not only do they reduce and even eliminate verification needs, but they can withstand difficult and unpredictable environments. Some are intrinsically safe, making them perfect for potentially explosive environments, and most can be submerged.

He discussed the changes that need to be made to adopt validation dataloggers, (i.e. protocol updates, pre/post verification considerations, handling battery life and replacement, and handling calibrations). He covered factors that need to be contemplated like the temperature range to ensure the efficacy of batteries, and questions that need to be considered regarding the need for live data. Mr. Daoust finished with a review of various verifications and calibrations topics for further individual consideration.

 

Kevin Loomis of Panasonic Healthcare NA discussed chamber mapping, including current best practices, choosing the right temperature mapping equipment, and protocol considerations.

He began his presentation by explaining the importance of temperature mapping. Equipment and facilities are temperature mapped to verify that they have the ability to meet specified performance characteristics. Specifications are established using URS, DS, FS, regulatory compliance criteria and established specifications for the products of the application. He shared a step-by-step guide to successful temperature mapping planning. The first step is to determine the critical mapping points and the sample rate. Then, data logger criteria must be established, and the loggers must be places at pre-determined points. After this, the logged data must be captured, retrieved and evaluated. Once this is done, the documents can be processed and if need be, the process is repeated. Mr. Loomis explained the differences in equipment, and the advantages and disadvantages of each kind. He spoke about sensor placement, and how it should follow a risk-based approach using design considerations and expected use. He remarked that location considerations follow the same methodology regardless of chamber size. He touched on refrigerators, freezers and cold rooms, as well as incubators and ovens, which require proper air flow in order to ensure uniformity and temperature control (it is important to note that cold wall units are not subject to air flow issues because they remove heat using evaporator coils encased in the chamber walls).

After touching on autoclaves, warehouses and dry storage chambers, he focused on uniformity testing and dynamic testing. Temperature mapping data helps determine areas in the chamber that may not meet specifications. He concluded with the characteristics of loaded versus empty chambers, saying that loaded chambers typically produce better data as the mass aids in buffering temperature fluctuations.

 

Both powerpoint presentations can be viewed and are available for download here.

 

Here are some pictures from the event!

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