Limit for Temperature & RH in Pharma Clean Room

raghu_1968 said:

The query is related to the limit for Humidity which has to be maintained in (Pharma area) clean room.

As per the guideline 14644, the typical set range of relative humidity is 30 to 65%.

During my audit to one of the supplier facility, the limit fixed for the relative humidity is 35 to 70%.

However they have qualified the area with the 70% RH.

The concept is, the temp. & RH maintained at clean room should cover our stability conditions of 25°C & 65% (RH). Here the value 70% is beyond the 65%,

The upper limit of fixing the value of 70% is acceptable?

Regards / Raghu

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raghu_1968 said:

The query is related to the limit for Humidity which has to be maintained in (Pharma area) clean room.

As per the guideline 14644, the typical set range of relative humidity is 30 to 65%.

During my audit to one of the supplier facility, the limit fixed for the relative humidity is 35 to 70%.

However they have qualified the area with the 70% RH.

The concept is, the temp. & RH maintained at clean room should cover our stability conditions of 25°C & 65% (RH). Here the value 70% is beyond the 65%,

The upper limit of fixing the value of 70% is acceptable?

Regards / Raghu

Click to expand...

raghu_1968 said:

The query is related to the limit for Humidity which has to be maintained in (Pharma area) clean room.

As per the guideline 14644, the typical set range of relative humidity is 30 to 65%.

During my audit to one of the supplier facility, the limit fixed for the relative humidity is 35 to 70%.

However they have qualified the area with the 70% RH.

The concept is, the temp. & RH maintained at clean room should cover our stability conditions of 25°C & 65% (RH). Here the value 70% is beyond the 65%,

The upper limit of fixing the value of 70% is acceptable?

Regards / Raghu

Click to expand...

BradM said:

Hello, Raghu!

I guess I don't understand the question. First, is there an ISO classification for the area?

Also, exactly what is the room supposed to be controlled within? Is there product/equipment in the area that has temp/ RH requirements?

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somashekar said:

As he is your supplier could you ask him to keep the limits to 25% to 65% and can he provide and maintain this with his infrastructure ?
The question is .. Do you have a non conforming product attributed to this setting or you see a potential non conforming product due to this ?

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raghu_1968 said:

The query is related to the limit for Humidity which has to be maintained in (Pharma area) clean room.

As per the guideline 14644, the typical set range of relative humidity is 30 to 65%.

During my audit to one of the supplier facility, the limit fixed for the relative humidity is 35 to 70%.

However they have qualified the area with the 70% RH.

The concept is, the temp. & RH maintained at clean room should cover our stability conditions of 25°C & 65% (RH). Here the value 70% is beyond the 65%,

The upper limit of fixing the value of 70% is acceptable?

Regards / Raghu

Click to expand...

Ajit Basrur said:

It is typical and not mandated. Is your question referring to the RH ranges between Clean room where the product is manufactured vs the stability chamber RH conditions ?

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raghu_1968 said:

Absolutely yes.

Regards / Raghu

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