WAREHOUSE CLIMATIC MAPPING
Click anywhere on image for further details.Initial Studies and Justifications.
Warehouse climatic mapping is required whenever regulatory controlled product is stored either between processes or as a finished product in the warehouse. There is a cGMP requirement that the warehouse storage conditions must be validated. This is to verify that where storage conditions have been specified; they are complied with, and where they are not specified; to ensure that the storage conditions will not cause irreparable damage to the product or the product packaging or any appended documentation. Where there are no conditions specified then best practice must be followed and best practices are available in guidance documents from regulatory authorities world-wide. These should be discussed and a documented justification for the values adopted included in the Validation Plan.
Validation of these storage climatic conditions must verify that all shelf and free standing areas where product is to be stored; must remain within the temperature and humidity levels specified in the storage specifications for the product. These storage conditions must be maintained regardless of seasonal variations in the local ambient weather system. Where these are extreme it may require the validation task to be run continuously through theses seasons or simply repeated during their occurrence. This matter should be discussed and a documented justification included in the Validation Plan.
For many years warehouse climatic mapping tasks involved running hundreds' of metres of sensor cable and weaving in out shelving, across access passages and generally making life difficult for the often exasperated warehouse staff. Now; using wireless individual data loggers the task has become a lot less intrusive, individual data logger sensors can be attached to shelving support structure (using adhesive tape), so keeping them clear from the routine product movement that the shelves are subjected to. In fact the sensors can be installed discretely in a matter of minutes and left unattended for the complete duration of the mapping exercise.
The number of; and location of; individual data logger sensors required for successful warehouse climatic mapping is governed by several factors, disruptive air flow entering or leaving the storage area, distribution of conditioned air inlet and exhausts, open doorways and or windows and generally the environmental insulation to walls and ceilings. A typical layout for 1000 square metre warehouse climatic mapping with shelves stacked 4 metres high; good general wall and roof insulation; no open doorways or windows and evenly spaced-out condition-air inlets and exhausts, could be one sensor in each corner of the storage area, and one midway along each wall, with one in the centre. This means nine sensors would be placed on the lowest storage shelf, then nine on the middle shelf and finally nine on the top shelf. Smaller rooms could be scaled similarly, with one sensor in each corner and one high layer and one lower layer, giving a total in a smaller room of eight sensors. If there are disruptive influences to the general air in /out flows or to the location of the conditioned air inlet and or exhausts then these location would have to be altered and would possibly have to be establish by conducting preliminary warehouse climatic mapping air flow studies. However when the position and number of sensors has been agreed, the justification for your choice must be documented in the Validation Plan. Are you beginning to see just how important the Validation Plan is?
Data logger Specifications.
As stated above the advent of the low priced accurate data logger has changed the task of climatic mapping large buildings and warehouses. We now use these data loggers for all large temperature and humidity mapping tasks. It has cut the cost dramatically. It has also simplified the task considerable and changed the task from one that had to be carefully planned and integrated to cause minimal disruption, to one that now goes barely noticed.
Data logger Specifications.
As stated above the advent of the low priced accurate data logger has changed the task of climatic mapping large buildings and warehouses. We now use these data loggers for all large temperature and humidity mapping tasks. It has cut the cost dramatically. It has also simplified the task considerable and changed the task from one that had to be carefully planned and integrated to cause minimal disruption, to one that now goes barely noticed.
The specification of the data loggers we use is given below:
Data
Storage Capacity 16,382 Temp and Humidity Readings
(32,764 Total Readings/Samples) Humidity
Measurements Range: 0 to 100% RH
Repeatability:
±0.1%RH
Accuracy: ±3.0%RH Overall (20 to 80% RH)
Internal
Resolution: 0.5 %RH
Long Term Stability: 0.5 % RH per Year
Temperature
Measurements Range: -35°C to 80°C (-31°F to
176°F)
Repeatability: ±0.1°C (±0.2°F)
Accuracy: ±0.5°C
(±1°F) Overall
Internal Resolution: ±1.1°C (±2°F) Overall
Dew
Point Accuracy
(overall
error)
(25°C,
40-100%RH) ±1.1°C
(±2°F)
We supply these data loggers in multiples of five. Each multiple is supplied with its own DVD containing a copy of the associated software.
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Risk Mitigation in Validation template (Issue 11) $125.00 The Risk and Part 11 Validation Risk Assessment(VRA) protocol is becoming the most important document in the validation online train. The VRA reassures the regulators that you have looked at specific equipment functionality and considered the appropriate level of validation that is required. You have also considered various aspects of its use and the implications of any malfunctions. From the results of this exercise the scope of all validation activity can and must be justified. This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your Risk Mitigation in Validation template.
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This Pharmaceutical Validation combination protocol has been produced in response to several hundred reader suggestions we received in our ‘Suggestions Section’. It has been carefully designed to make it the preferred choice for Process and Laboratory stand alone equipment and associated standard operating procedure TEMPLATE. The associated medical device validation Master Plan template is interactive, easy to use and suitable for all mixes of equipment with and without software. Where temperature mapping is required it will included in this section. This of course may well be a Risk Mitigation in Validation risk Assessment template. As per 21 CFR Part 11.
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