Temperature mapping

TEMPLATES & PRESENTATIONS
1

Temperature mapping for RM/ Finished goods:

1.How many days mapping to be done
2.What are the points should consider temperature mapping
3.How can select hottest point for regular monitoring purpose
4.When temperature mapping required?
5.How can select the location for data logger for fixing
6.Sample Frequency during mapping
7.What type of data logger to be select
8.Why required for ambient conditions are monitored during mapping?
9.Power failure and Door opening study is required for raw material storage,controlled substances storage area, finished goods, in-process holding materia
10. Frequency and interval of temperature mapping

Regards
Sivakumar

2

24 hours to 72 hours(3 days ) required as per WHO and USP.

  1. 3 days(72 hours ) as per USP
  2. Entire range must be covered in the room.
  3. After completion of 3 days study , Hot point is reported.
  4. New house.
  5. 4 Corners(upper and lower) and 1 middle of the roof.
  6. Every 10 minutes
  7. Calibrated data logger certified with GOVT metrological Labs
  8. seasonal variations.
  9. Power failure and Door opening study is required
  10. One time study.

Reference WHO Guideline for mapping storage areas.

http://www.who.int/biologicals/expert_committee/Supplement-8-TS-mapping-storage-areas-ECSPP-ECBS.pdf

Regards,
Bujji Reddy.Kanchi.