CO2 Incubators - Equipment Qualifications in addition to Calibration

[Metron]

Our Metrology department performs the equipment qualifications in addition to the calibrations.
Currently our CO2 incubators are qualified at 37 Degrees and 5% CO2. continuous changes by the user is now required.
What is required to maintain control and still allow the processes to continue?
An example of change is to set the incubator to 36 Degrees 8% followed by 32.5 degrees at 0% and 38 degrees with 2% CO2 . Several other points may also be required. All of this is scheduled to occur over about a week to 10 days. Currently we issue a change Control and perform calibrations and full qualifications(empty ,loaded, open door, power failure) for each set point change.
This seems extreme and causes up to a month of process halt until the change control and the new qualification documents are signed by QA. in my 30 years of performing these tests we have not had a single failure that was temperature or CO2 related. This causes my question of why do we do this?
There must be a logical and more cost effective way to change a set point of an incubator and still remain compliant to GMP and FDA regulations. I welcome any suggestions as i cannot find any detailed regulations requiring these actions.

 

[Ronen E]

Re: Equipment qualifications in addition to Calibration - CO2 Incubators

Hello Metron and welcome to the Cove

I'm not sure I fully understand the intended use. What are these incubators used for? What does the user interface allow? Does it have user-operable controls for temperature and CO2 percentage? What is the declared tolerance around set targets? Etc.

If you want to change the device from a single set point to user-controlled, I'd go for a formal change under change control / design control and then verify and validate that the user-operated control works as expected.

 

[Metron]

Re: Equipment qualifications in addition to Calibration - CO2 Incubators

Thanks for responding,
These are standard Thermo incubators easily front panel controlled.
thank you for the suggestion it helps for some of my issue.
the difficult part is justifying in an audit that the incubator is in a qualified state per FDA and GMP regulation. Currently with each set point change, I issue a Change Control, re-perform full qualifications(empty ,loaded, open door, power failure)and this is very time consuming and costly to our client.
Do you have any suggestions that may ease the pain of this current practice?

 

[Ronen E]

Re: Equipment qualifications in addition to Calibration - CO2 Incubators

Honestly, I don't understand the problem. I am assuming that this is a Medical Device and that the applicable regulations (what you refer to as "FDA and GMP") are those that apply to Medical Devices. If it's not a Medical Device, could you please clarify as what sort of entity it is regulated?

If it is indeed a Medical Device, I don't understand the regulatory basis for your practice. If the device has a user-accessible control panel, the device's performance should be validated once when a design change occurs (eg extension of temperature range capability). That validation should cover all possible/allowable user interventions (excluding perhaps abnormal use, ie deliberately and conciously going against issued instructions). Changing a parameter target via user-accessible controls, in line with manufacturer issued instructions, is not considered a design change.

I am not familiar with any specifics of incubators regulation (eg Special Controls, if any exist) so if there is such regulation, or some related FDA guidance, that dictates your current practice, could you please call it out so that I could have a look and maybe better understand your situation?

Cheers,
Ronen.

 

[Metron]

Re: Equipment qualifications in addition to Calibration - CO2 Incubators

Sorry for the confusion, let me start with what we have and what we now need.
We currently have a Thermo model 3910 Co2 incubator.
It was initially qualified at the parameters of 37+/-2 degrees and 5%+/-2% for CO2.
Now multiple points are needed to be used for the new processes.
Our QA is requiring each needed set point needs to be qualified (empty ,loaded, open door, power failure). I am looking to see if anyone has a different take and an alternate action. I am unable to find a specific regulation, only that the Incubator must be kept in a qualified state. Any suggestions?

 

[Ronen E]

Re: Equipment qualifications in addition to Calibration - CO2 Incubators

Instead of qualifying individual set points I would validate the entire range through qualifying the extremes and some representative points in between. DOE techniques can be used to reduce the number of individual runs required for covering the entire range(s). Once this has been done you could completely drop the individual qualifications as long as the device design is not changed and the validated range is not exceeded.

Perhaps I still don't fully understand you; hopefully some other forum participants will contribute their angle.

Cheers,
Ronen.