How the division of area is done for temperature mapping study in an ISO 8 class area for a pharma formulation facility
from my experience temperature mapping a room it is broken up into different areas for example top, middle and bottom then you would have probes in the top right corner, top left hand corner top middle repeat for the middle and bottom of the room. Obviously it also depends on the size and what exactly is in the room. You should have a probe also beside you control probe which maybe be you facility monitoring system probe?
I have validated incubation chambers this way so I hope this is of some assistance.
thank you for reply
As per my experience, Thermal / Temperature Mapping can be done as follows:
- Thermal mapping protocol / guideline shall be prepared.
- Depends on the room volume, use Probes / Individual small data loggers (If the room is so huge, data loggers can be used).
- Prepare a diagram in which you can propose for the probe location.
The probes shall cover all corners of the room.
- Justfication for the probe selection shall be given / mentioned.
- Conduct Empty load and Full load studies seperately.
- When using probes, it shall be connected to a Bigger data logger to monitor, record the data.
- Set the Interval time between two recordings and Define for howmuch time the study is going to be connected (lets say: 4 / 12 / 24 / 72 hours)
- Minimum & Maximum temperature shall be calculated during this study.
- Thermal mapping shall be done for the Worst Case Studies also like:
a) by using 1 or 2 compressors in running condition (if 2 or 3 compressors are available in that room)
b) by doing Power Failure Study
c) by opening the door for some time.
d) with more man power presence (to create the worst case)
e) Hot Seasons
f) Cold Seasons
I hope this will be useful for performing Temperature Mapping Study.
Y. S. Reddy - Manager (QA & Validation)
Subject: temperature mapping- storage area
Instead of probes can you use calibrated Temp/RH meters?
Are there any rules concerning the area of the room, for example you have to have 10 probes in an 100 m2 room?
Are there specific probing-maps /guidelines/recommended, if yes where can you get them???
Our facility is GMP licensed.
Thank you for your attention
ISO14644 does not specify numbers of probes, etc. It does emphasise minimum distances from walls, etc. The Area square root calculation is an air quality monitoring standard and should not be applied to this kind of study. You need to look at the room in a logical way, understand the air distribution throughout the room and consider the following as a minimum:
- Personnel movements
- Area size (cubicle vs warehouse)
- Heat stratification (warmer air rises, therefore air tends to be warmer at ceilings than at ground level in areas with fairly low change rates)
- Heat generating sources at working level (Human body temp, machine heat exhaust, etc)
- Room shape (regular 4-sided square/rectangular shape, irregular polygonal areas with dead space)
- Obstructions (machine installations, racking, etc)
- Air change rates. Warehouses with 5 air changes equilibrate more slowly than cubicles with 30 air changes.
Once these factors have been evaluated, you can decide on a mapping strategy. Minimum for cubicles would be 4 sensors in each corner at high and low level, usually about 30 cm away from the nearest wall, with 1 sensor in the middle at working height. For larger spaces, use 15 - 30 sensors, spaced at regular intervals at low-level, working level and high level to account for the factors mentioned above.
Hope this helps
Im agree with you. And I would like ask you about MKT is acceptable or not during temperature mapping? If there are some time the temperature is out of specification but MKT meet requirement? How can we conclusion Pass or Failure?
Yes, you can say …it’s Pass.