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GMP-compliant temperature mapping service - メーカー・企業と製品の一覧

GMP-compliant temperature mapping serviceの製品一覧

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GMP/GDP compliant temperature mapping service

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.

  • Other services

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Temperature mapping service compliant with GMP/GDP.

By mapping the temperature, it is possible to evaluate the temporal and spatial characteristics of the temperature within the warehouse.

We would like to introduce our "Temperature Mapping Service" in compliance with GMP/GDP. In the storage of pharmaceuticals, temperature mapping is necessary to measure the temperature distribution indoors for compliance with GMP and warehouse validation. Even after the establishment of a new warehouse, regular mapping is required to confirm the validity of the existing sensor positions. Our company provides this service to support our customers in their audit responses and also offers various systems for continuous monitoring. [Purpose] ■ Understanding of worst points (highest and lowest temperatures) - Reference for the installation positions of sensors for continuous monitoring - Judgment and evaluation against management values for each room and warehouse ■ Operational qualification (OQ) assessment for validation of new warehouses ■ Performance qualification (PQ) assessment for existing pharmaceutical warehouses and cold storage *For more details, please refer to the PDF document or feel free to contact us.

  • Other contract services

ブックマークに追加いたしました

ブックマーク一覧

ブックマークを削除いたしました

ブックマーク一覧

これ以上ブックマークできません

会員登録すると、ブックマークできる件数が増えて、ラベルをつけて整理することもできます

無料会員登録