I am in project work of small volume paranteral plant. Recently we are going to start room temperature and RH mapping. My question is how to calculate the mapping points for rooms. Is there any formula to calculate it by using room volume. Which guideline can I prefer for the same.
ISO 14644-1 “Classification of air cleanliness by particle concentration” has the following table for the number of locations for air sampling in cleanroom areas.
Dear Mr. Ankur Choudhary,
I didn’t ask about sampling in cleanroom areas. I have asked about Temperature and RH mapping. How can I calculate of Temperature and RH mapping points for rooms. Is there any formula for it. Please suggest guidelines for room temperature and RH mapping.
I need these validation parameters & how it perform.
1.Air velocity measurement.
2.Particle count test
3.Room pressurisation test
4.Air flow visualisation test
5.Light intensity test
6.Noise level test
7.Air exchange rate
10.Temperature & humidity test
Please refer the document
Refer the following document
Thank you Mr. Ankur Choudhary,
I read that article, in which the guidelines ISPE is mentioned for number location for particular room volume. But in which volume of ISPE (and which edition).
You can refer to -ISO14644-1&14644-3I for frequency,limitsand for parameters.
No of Probes / Sensors shall be based on the following criteria,
a. Based on the Area
b. Based on the Worst case conditions
The Minimum number of probes / sensors shall be determined by using the following formula
N = √(A) + 1
Where N: Minimum number of sampling locations (rounded up to a whole no.)
A: is the area of the room in square meter.
Placement of probes
a. Areas near the exterior walls so that it may stay warmer or cooler in response to temperatures outside.
b. Racking, shelving areas since they may create “hot spots” by obstructing air circulation.
c. Near the doors since the doors that are left open will affect temperature conditions.
d. Near the Exhaust Grills.
e. Document the location of each sensor / probe and label each sensor / probe to ensure that it is not repeatedly placed in the same location.
f. To ensure consistency practice the following rules:
Using the data logger software, name each sensor / probe by its location,
Label the exact spot where the sensor / probe should be placed by the location name,
Create a physical map with all sensors / probes marked by name.
Kindly clarify the calculation of total air change for determination of air change per hour.
Could you explain formula for allocating no. of Data logger to be placed with respect to 3 dimension space of room volume, as I think It will be more appropriate than 2D…
Thanks and regards…