You can refer to IEC 60068-3-5-2001"Environmental testing Part 3-5: Supporting documentation and guidance. Confirmation of the performance of temperature chambers".
There are examples for placing 9 data logger.
Hope this would be helpful.
Regards
Temperature Mapping Test Protocol Example:
Temperature Uniformity Verification
Test Objective: To verify the temperature uniformity within the Oven chamber at empty load condition.
Acceptance Criteria The Oven chamber is capable of maintaining temperature of XX ± 10 °F for minimum of XY minutes.
Test Tools Required:
a. Calibrated Kaye Validator® and Kaye Validator Software
b. Type J or K Thermocouples (TCs)
c. Calibrated IRTD
d. Temperature Reference (Temperature Well)
- Number, identify, and calibrate a minimum of 10 thermocouples at the following temperature setpoints using the Kaye Validator® & Temperature Reference.
Setpoints: Low: X °F, Midpoint: Y °F, High: Z °F - Place thermocouples inside empty Oven chamber (a minimum distance of 6” from the walls for all locations) at the following locations (See TC Location Diagram):
a. Top front right
b. Top front left
c. Top rear right (Next to Equipment’s Control Temperature Probe)
d. Top rear left
e. Center of chamber (horizontally)
f. Center of chamber (horizontally)
g. Bottom front right
h. Bottom front left
i. Bottom rear right
j. Bottom rear left
Note: A “TC Location Diagram” can either be inserted in the protocol or attached with the protocol. - Turn equipment (freezer) power ON (if not already powered on).
- After all TC readings are stabilized at around set temperature, start Kaye Validator for Temperature Mapping study. Collect temperature readings for minimum of 30 minutes.
- After the completion of temperature recording, perform “Calibration Verification” of all thermocouple used, at check point/Midpoint of Y °F.
- Prepare Kaye Validator Reports for the followings:
a. Kaye Validator Setup Report
b. TC Calibration Report
c. TC Calibration Verification Report
d. Qualification Report (Raw Data from Kaye Validator)
e. Graphs and other modified reports - Verify the data on Chart Recorder, as applicable.
- Record tools/instruments detail in this section.
Setpoint Temp: XX °F Cycle Time: XY minutes
Attach a copy of Calibration Report.
Obtain Quailification Report from Kaye Validator and record the actual results.
Compare all minimum and maximum temperature readings of each thermocouple and determine whether they are within XX ± 10 °F.
TC # Min Max
TC 01
TC 02
TC 03
TC 04
TC 05
TC 06
TC 07
TC 08
TC 09
TC 10
Actual Duration of study
Circular Chart Recorder Print/Copy attached: Yes
3 Calibration Verification:
Attach a copy of Calibration Verification Report. All TCs passed Calibration Verification.
Have any of you worked at a GMP facility…any facility??? Or do you just sit in front your computer all day answering questions you don’t know a thing about.
Okay enough of that I feel better now. In a nutshell Validation is a testing process that can be applied to computer systems, equipment cleaning processes, manufacturing processes, analytical test methods, etc. Health authorities and GMP regulated companies have developed validation processes with a specific purpose: to provide Quality Departments a process for documenting that a system can and will give results that are CONSISTENTLY within PREDETERMINED requirements.
Qualification is a lower level but yet integrated process involving the testing of computer software Hardware, infrastructure, Laboratory equipment, etc. Performing qualification on a piece of equipment provides documented evidence that the equipment can function properly and can perform all the tasks you want it to perform.
Qualification and validation are related even though there are two separate Concepts. In a way qualification is a part of validation-- an area cannot reach a validated state without good qualification of all the individual systems that make up that area. Validation differs from qualification though, validation is a much more complex process that involves more time, resources, and money.
I could talk about this all day butt you’re likely not going to understand it just reading. There is a reason why you didn’t understand a word of what you read before you word vomited on this forum… I’ve been working in big Pharma quality over 10 years and it took me a long time to understand these Concepts. Validation is no little BS thing you can learn on the Fly to impress your friends. So stop misleading people who may actually be trying to learn something. I’m not trying to complain but there is 22 other responses on this thread. I have read every single one of them and every single one of you is talking out of your butt.
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(1) Temperature mapping of storage areas
Technical supplement to WHO Technical Report Series, No. 961, 2011
(2) Controlled temperature chamber mapping ISP- April 2012
BigPharma,
What is your role with BigPharma? QA, validation, labs? We would love your expertise, but would like you to be a lot more courteous when you do it.
Thanks,
JaredCroft
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Yes I would like to second what @JaredCroft has said, we run a friendly open community @BigPharm501 so let’s keep it that way.
Thank you
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I doubt you even have the basics of being in a big pharma company. Go get qualified first in talking decently to others. you need soooooo much trainig. what a pity