5 Frequently Asked Questions about Temperature and Humidity Validation / Mapping

The US Food and Drug Administration (FDA) tells us that we must identify the environmental conditions that can affect the strength, identity, safety, quality, and purity of our regulated products. Temperature and Humidity Validation/Mapping can be a difficult task to complete. Whether you are an end user or a hired mapping contractor rest assured this document will demystify the 5 most frequently asked questions regarding Validation/Mapping.

What limits should I use as an acceptable range for my study?
What type of sensor(s) should I use?
How many sensors do I need, and where should I place them?
What kind of calibration do my sensors require?
What is the appropriate duration for a mapping study?

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