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  6. GMP/GDP compliant temperature mapping service

GMP/GDP compliant temperature mapping service

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last updated:Sep 17, 2024

セントラル科学貿易
セントラル科学貿易
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We support the validation of pharmaceutical storage cabinets!

"Temperature mapping" refers to the installation of multiple temperature loggers and the analysis of measurement data over a certain period. By conducting temperature mapping, it is possible to evaluate the temporal and spatial characteristics of temperature within a warehouse. Using the installation positions of sensors for continuous monitoring as a reference, assessments and evaluations are made for each room and each management area of the warehouse. [Frequency of Temperature Mapping Implementation] ■ When relocating a warehouse ■ When there are changes in the product accumulation state or air conditioning system ■ Once every three years ■ For rooms affected by seasonal changes: summer and winter ■ When temperature behaviors, such as difficult-to-explain spikes, are observed in continuous monitoring *For more details, please download the PDF or feel free to contact us.

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温度マッピング1.PNG

GMP/GDP compliant temperature mapping service

温度マッピング1.PNG
温度マッピング1.PNG
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【Temperature Mapping Process】 ■STEP 1: Hearing on management values and other conditions ■STEP 2: Confirmation of the installation location and method of the temperature logger on-site ■STEP 3: Submission of the estimate ■STEP 4: Creation and submission of the plan document (manual) ■STEP 5: Installation of the temperature logger and start of logging (measurement) ■STEP 6: End of logging and collection of the temperature logger ■STEP 7: Data analysis *Data processing and analysis are conducted using Part 11 compliant software ■STEP 8: Creation and submission of the report *For more details, please download the PDF or feel free to contact us.

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GMP/GDP compliant temperature mapping service

GMP/GDP compliant temperature mapping service

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セントラル科学貿易

セントラル科学貿易

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