Temperature mapping of cold room

GOOD DOCUMENTATION PRACTICE (GDocP) PQ (PERFORMANCE QUALIFICATION)
1

i need protocol of temprature mapping of cold room if anyone has format of this protocol pls help me to sending the format:)

2

Hi :slight_smile:

Our company is a GMP facility. I am looking for a temperature mapping protocol for fridges. Is there a standard template for this? If anyone can share this it would be greatly appreciated.

Thanks

Kalyani

3

Hi Sanjib
Protocol is paid document…so i think nobody can help you…better go the tha ISO guide line…

4

Hi,

Have you thought of using a Temperature Mapping Kit?

Everthing is supplied to you with the loggers already pre-set, we tell you where to put them, send them back to us and we will produce a full report complete with;

Full Report
Recommendations
Statistical report
Graphs
etc…
contact: lyn.radnell@coolpac.com

5

[quote=kchari]Hi :slight_smile:

Our company is a GMP facility. I am looking for a temperature mapping protocol for fridges. Is there a standard template for this? If anyone can share this it would be greatly appreciated.

Thanks

Kalyani[/quote]

Dear Kalyani,
You can refer the key contents of PQ of refrigerator as follow.
Objective is to demonstrate that the refrigerator is capable to maintain design/intended temperature range.
Following may be the typical test which can be included in OQ/PQ protocol.
1-Temperature pool down time.- Empty Chamber
2-Empty chamber distribution
3-Loaded (may be partial) chamber distribution
4-Power failure test (meant to evaluation the time for which refrigerator can maintain intended temperature with or without normal door opening.)
5- Door opening test (Meant to evaluate the max time for which refrigerator door can be kept open without allowing it to cross upper limit of temperature range)
6-Optionally hot spot can also be identified
Rgds
Ravi Dhanbhar

6

hi frnds,
could any one tell me what is the acceptable temperature difference bettween two temp probes during temp mapping of the chamber

for eg in autoclave validation normaly we consider 0.5 degree is the acceptable limite likwis wat is the limit for stability chamber/ cold storage room during temp mapping.

Regards,
Jagadeesh