Question 1

How many sensors are needed to map our –20°C freezer room?

Accepted Answer

Sensor count depends on chamber volume and internal obstacles such as shelving, airflow baffles, and door positions. IQ/OQ/PQ best practice and GDP guidance recommend a minimum of one sensor per 10 m³, with additional nodes placed at known risk locations like door seals and near evaporator coils. Seemoto provides a pre-study layout plan so you can approve placement before any equipment enters the freezer.

Question 2

Does the mapping study need to be repeated after we modify the freezer shelving?

Accepted Answer

Yes — any structural change that alters airflow patterns constitutes a change that triggers re-qualification under GMP Annex 15. A targeted partial re-map focusing on the affected zones is usually sufficient and less costly than a full repeat study. We document the change-control rationale in the updated mapping report.

Question 3

Can the mapping data be used directly to support our GMP site master file?

Accepted Answer

Yes. The mapping report is structured to serve as a qualification document that can be referenced in your site master file and included in batch records or audit dossiers. It includes sensor calibration traceability, raw data exports, deviation summaries, and a signed conclusion statement confirming whether the chamber meets its defined temperature specification.

冷冻库温度映射

冰柜冷点探测

包含与可选功能

标配

可选附加组件

相关无线温度测绘产品

常见问题

规划冷冻库温度验证