Stability Chamber Requalification

Greetings All:
We currently have a 3 year re-qualification requirement on our walk-in and reach-in chambers. I’ve been asked to look through the years of data to give creditability to this time period or justify lengthening it. Within the company other sites and departments have other requirements like a four year re-qual time period and others have no re-qualification requirement at all. Does anyone know of an industry best practice? I’ll end up going through the laborious process of doing a risk assessment but it would be helpful to follow the industry norm if there is one.
Regards,
Socrates

[quote=Socrates]Greetings All:
We currently have a 3 year re-qualification requirement on our walk-in and reach-in chambers. I’ve been asked to look through the years of data to give creditability to this time period or justify lengthening it. Within the company other sites and departments have other requirements like a four year re-qual time period and others have no re-qualification requirement at all. Does anyone know of an industry best practice? I’ll end up going through the laborious process of doing a risk assessment but it would be helpful to follow the industry norm if there is one.
Regards,
Socrates[/quote]

I would hazard to say there isn’t a standard time frame as it would depend on the age of your chamber. New ones would most likely need less time before requalifying than old (due to wear and tear, what changes were made (motors etc).

If your SOP says you have to requalif after 3 years then do so. After that you can gather data to support a justification to change the time frame. I would look at change controls to the equipment, pm records, OOS reports (if anything) to support your justification in time frames.

I hope that helps.

[quote=seal]I would hazard to say there isn’t a standard time frame as it would depend on the age of your chamber. New ones would most likely need less time before requalifying than old (due to wear and tear, what changes were made (motors etc).

If your SOP says you have to requalif after 3 years then do so. After that you can gather data to support a justification to change the time frame. I would look at change controls to the equipment, pm records, OOS reports (if anything) to support your justification in time frames.

I hope that helps.[/quote]

Most of the companies, does annually.

Regards,
Bujji Kanchi.

[quote=bujjikanchi]Most of the companies, does annually.

Regards,
Bujji Kanchi.[/quote]

I’m sorry but I could not disagree more with that. I do not believe that companies remap and requalify ever year. I think you mean they calibrate any and all sensors.

I have only seen annual mapping on critical units (cell bank freezers). 3-5 years seems most common to me. Are the units on a monitoring system? If you can say the monitoring probe is in worst case location that would be good justification for reducing the mapping frequency.

In our case we have 5 monitoring points on each chamber independent from the control feedback. This way we are constantly monitoring the chambers. We calibrate every 6 months and do not re-qualify unless and event requires it.

We have stability chambers located within a building as well as external stability chambers in insulated enclosures. We map every 18 months to ensure seasonal variations are covered. First remapping in Winter, next Summer, next Winter etc.

As well as indicating potential deterioration in the performance of plant such as humdifiers, chillers, heaters, purified water systems it may also highlight issues were sealant is deteriorating between insulated panels, door seals may be deteriorating, loading patterns within the room may not be appropriate to allow proper airflow i.e. do samples overhang the front or rear of shelving etc. Remember 40degC / 75%RH is a harsh environment, it will cause issues over time if your original materials of construction weren’t specced sufficiently or if your preventative maintenance has been lax.

If you have a large room with a small number of monitoring probes you can only be ever sure that the room temperature and relative humidity in the proximity of the probes is within specification. If we could entirely rely on monitoring probes there would be no need to remap at all. In my opinion every 2 years would be the minimum frequency.

If you are an organisation storing potentially commercial product think about the value of the samples on stability and the importance of having robust systems in place. Mapping every 2 years doesn’t sound too bad compared to the potential impact, does it?

Please classify the activities done in calibration and Qualification Individually for a stability chamber .

Regards,
Bujji Kanchi.

[quote=bujjikanchi]Please classify the activities done in calibration and Qualification Individually for a stability chamber .

Regards,
Bujji Kanchi.[/quote]

All critical instruments must be calibrated - calibration

Verify that fully loaded Stability chamber achieves and holds required temperature and relative humidity

  • some of RQ tests…

Dear all,

for me also the following practical questions are interesting:

  1. When I perfrom OQ with empty chamber and PQ with loaded (filled) chamber I utilize Testo 174H data-loggers for temperature and humidity measurements. I never met a problem with temperature - it’s revaltively easy to maintain temperature with a tolerance +/- 2C. I prove this with a help of above mentioned data-loggers, because they have their own accuracy +/- 0,5 C. Another situation with humidity. Testo 174H have an initial accuracy +/- 3 % rH, but the requirement of the stability chambers are +/- 5 % rH. It seems to me, that it’s not siutable ranges, because even with negative results I couldn’t insist, that humidity conditions inside the chambers doesn’t met the requirements - my own mistake is too large. Who can give a practical explanations or advices?

  2. How do you perform periodic (annual) sensors calibration? As for me it’s not enough to check only one point, for example 60 % r.H. only, because in this case we doesn’t consider a possible slope. At the same time most of initial calibration certificates I’ve met contain only one point.

In my case there are Memmert HPP750.

Thank you in advance for possible replies

I’d say that the expected norm is that these things are risk assessed. What I would suggest is some sort of alignment of risk analyses between departments if you’re using the same equipment and the processes you undertake have similar criticality. It makes no sense that there are inconsistencies between the requalification of equipment which may be the same and be performing what is essentially the same function. If however your chambers are used for a more critical process than where used elsewhere, then the time period may be justified.

The updated annex 15 for requalification states: “Equipment, facilities, utilities and systems should be evaluated at an appropriate frequency to confirm that they remain in a state of control.” This is basically telling you to assess the frequency of requalification based on the criticality of the equipment to the process, criticality of failure, frequency of use, likelihood of failure etc.
It sounds like the bigger issue here are your risk assessment frameworks if you think of it as a laborious process. Only through robust risk assessment can you making decisions based on objective data which inform you about how to control processes. I gather your risk frameworks or lack of assessment historically may be the reason why you have this variability between sites in the first place.

Seal’s advice above is sound, but you’ll need to risk assess the frequency change as they alluded to.

Best of luck.

Anthony

Great thread guys!

1 Like