Observe the temperature and relative humidity through respective Exhibit device anywhere set up, use thermo hygrometer or temperature and RH sensor to check temperature and RH in rooms/region.

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For the pharmaceutical creation, the architectural components with the HVAC systems have an effect on performances like home force differential cascades, avoidance of contamination and cross-contamination control.

To make sure that the item may be safely transported within just the desired temperature profile Which compliance with regulatory needs and also the anticipations of fascinated functions may be demonstrated:

建立有据可循的 书面协议（composed protocols）和 预期结果（envisioned results）对于工艺确认非常重要。书面协议应包括 生产条件（production problems）、 数据收集（facts collections）、 测试（testings）和 取样计划（sampling strategies）。

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In the current methodology (by TOC or By HPLC) of analysis of residue content, there will always be some residue acquired in outcome.

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Calibration Position: Confirm the calibration position of instruments and devices used in the qualification process.

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