Oven Validation Protocol (procedure) needed

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J

Jeff Frost

#3
Trucle

Our Calibration Engineer recommends AMS 2750 as a starting point for calibration and survey methods for ovens.
 

BradM

Staff member
Admin
#5
First, a belated welcome to the Cove!:bigwave:We are sure glad you dropped by, and hope you tell your friends.

When you ask for an oven validation protocol, is this the FDA? Or, are you in the aerospace industry, and need to perform uniformity studies?

For calibration/ uniformity surveys, Jeff provided the "Handbook" so to speak, for the aerospace industry. That will let you know for your particular equipment how many T/C's, location, tolerance, etc.

For a validation, that is a little different story (for pharmaceutical industry); hence Harry's link. Your protocol should generally follow a pre-existing plan established for protocols. Per Marc's question, is this an IQ validation plan? or are you interested in temperature uniformity/ tolerance?

For temperature, you should place T/C probes uniformly throughout the realistic work zone, and verify deviation from the control probe, overshoot, recovery time, correlation to load probes, etc.
 
T

TrucLe

#7
Thank You for your help. I would like to know validation plan oven for temperature and humility (FDA). I need to validate oven before i use it to test shelf life of medical device. What the performance test i should do? (temperature test, humility ......)Please give advice.
 

BradM

Staff member
Admin
#8
Thank You for your help. I would like to know validation plan oven for temperature and humility (FDA). I need to validate oven before i use it to test shelf life of medical device. What the performance test i should do? (temperature test, humility ......)Please give advice.
Do you have a current validation plan in place at your facility? Is there any up-front functional specifications written for what the oven is supposed to do/is expected to do?

You should have a general layout on how you will proceed. You will need to perform an Installation Qualification, and then some level of Operational/ Performance Qualification.

As to actually validating the oven, it will depend on what you want to use it for. If you are dry heat sterilizing, then you will probably have to verify sterility issues along with the functionality of the oven.

It's important that your validation documentation follow any standard approach you have within your organization for validation, and to address the requirements established (hopefully) when the equipment was purchased.
 
D

dataglo

#9
Do a search on GHTF.org. Its medical device specific but it identifies requiements for IQ, OQ PQ. If you still need support after that detail on the forum the paremeters your trying to validate.
 
R

rogerheffington

#10
I would like to clarify terms: You validate a process and qualify equipment, You must qualify equipment that you wish to use in a process. Then you validate the process. When I perform an IOQ on an oven, I always conduct uniformity and distribution studies. Additionally, if it is a depyrogenation oven, there would be biological challenges. May I ask: did you recieve the sample protocol you are seeking?

Roger
 
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