Webinar1501

What is temperature mapping?

• All answers are correct
• Temperature mapping is the study of temperature distribution

• Temperature mapping is to define hottest and coldest spot

• All answers are incorrect

Below is the objective of doing temperature mapping, except:

• To satisfy management committee

• To satisfy authority as part of QMS

• To ensure the safety and consumer well being

• Improper storage condition can damage product and cost thousands in wasted product

Temperature mapping need to be done in these types of storage conditions:

• Ambient Temperature

• Temperature controlled storage

• Freezer

• All answers are correct

What is the minimum accuracy of the EDLM to be used for temperature mapping?

• ± 0.1°C

• ± 0.5°C

• ± 1.0°C

• ± 5.0°C

Below are items to be checked during Operational Qualification (OQ) of Controlled Temperature Storage, except:

• Calibration of controllers and sensors

• Power failure test

• Temperature Mapping - Full

• Temperature Mapping - Empty

What is the recommended number of data loggers to be used for conducting temperature mapping activity of small storage area (below 2 meters cubic)?

• A. 5

• B. 10

• C. 15

• D. 20

These factors should be considered for doing temperature mapping of large ambient temperature Warehouse, except:

• Seasonal Variations

• Volume / load mass of products being stored

• Racks and Shelving

• Power failure

These factors should be considered for doing temperature mapping of small temperature-controlled storage cabinet, except:

• Seasonal Variations

• Volume / load mass of products being stored

• Air circulation

• Power failure

Below is correct statement regarding MKT, except:

• Must be calculated using Kelvin

• Correlate with product degradation during stability study

• Can be implemented for temperature and humidity

• All statements are correct

Below are acceptance criteria of Temperature Mapping process, except:

• Homogen temperature distribution

• No temperature excursion

• Using MKT calculation to justify temperature outside limit

• All answers are correct