WAREHOUSE CLIMATIC MAPPING


This is a graphic used in Warehouse Climatic Mapping.


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.

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.


WAREHOUSE CLIMATIC MAPPING



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Validation Plan (Issue 8)
$89.00  10000008

This document follows our well developed method of using a generic document and allowing the customer to apply an attached detailed SOP to it, turning the generic document quickly into a first class company bespoke document. This VP details and integrates all validation activities and procedures required for a small to medium sized project, involving production/facility/utility equipment using electronic controls or monitoring.

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Validation Risk Assessment (Issue-11.)  $125.00
10000014

The Risk and Part 11 Validation Risk Assessment(VRA) protocol is becoming the most important document in the validation 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 validation activities.
This VRA now includes the assessment table for categorising and documenting the new 21 CFR Part 11 guidance ruling on what predicate data must be stored in a Part compliant system, along with the new broadsheet to establish your new database of part 11 records. (now mandatory).

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Cold Chain Zone IQ (Issue 5)
$115.00  10000401

The SOP used to generate this IQ, takes you through the process line by line, chapter by chapter. It really is unique to find a SOP document so easy to use, all the work is done for you. All the documents are detailed, all the drawings listed and all the checks and tests detailed. The final product is a professional and comprehensive Installation Qualification Protocol for your temperature controlled cabinet or room. One that you can produce in less than 60 minutes. Yes, think about it, we all know how long producing IQ documents has taken in the past. There is now no reason for not being able to produce 4 to 8, IQ protocols per 8 hour day.


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Cold Chain Zone OQ (Issue 7).  $115.00  10000404

You will find the step by step attached SOP delightfully simple and straightforward to use, as it takes you through the process of customization of your Operational Qualification Protocol template. Following the attached SOP will quickly and smoothly convert your template into an equipment specific Operational Qualification Protocol for your temperature controlled cabinet or room. The OQ template comes complete with all the standard test scripts, more specialist test scripts can be found listed below. These can easily be pasted into the standard OQ, allowing you to quickly build your own fully detailed and referenced company bespoke Operational Qualification Protocol.

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Cold Chain Zone PQ (Issue 4)
$89.00  10000408

The Performance Qualification is the last of the qualifying tests that equipment and processes are subjected to, prior to the actual first product run. It maybe that there are some steps in the process that can only be verified by actually running them (quick freezing and sublimation, to mention only two) or it somtimes is the fact that the product is a very expensive product, and can not be wasted. So no one wants to run the process with product, until they are completely certain there will be minimal waste.

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Cold Chain Validation Package (Issue 3)  $1575.00
10000399
Level Two.
You want to validate a cold container or a mobile cold cabinet or a vehicle integral container or smaller service van.  In this case you require the following validation protocols;   This package is complete with all the validation documentation you require to validate the climatic condition within a warehouse a room or a large cabinet. Documentation includes our interactive and detailed Validation Plan (VP) the Validation Risk Assessment (VRA) the really easy to use Installation Qualification (IQ), the Operational Qualification (OQ) and finally the Performance Qualification (PQ). Along with the documentation are 10 highly accurate and easy to use data loggers ready to monitor and record close to 17K (each) parameters over what ever time base you select. This is now the simplest most expedient and most cost effective method of validating the climatic condition within any climatically controlled zone.
Each of these protocols are interactive and fully detailed.
VP, VRA, IQ, OQ, PQ.
This package consists of one of each of these documents.

Quantity

Cold Chain Validation Package (Issue 3)  $575.00 10000399
Level One.
You want to validate a cold container or a mobile cold cabinet or a vehicle integral container or smaller service van.  In this case you require the following validation protocols;   This package is complete with all the validation documentation you require to validate the climatic condition within a warehouse a room or a large cabinet. Documentation includes our interactive and detailed Validation Plan (VP) the Validation Risk Assessment (VRA) the really easy to use Installation Qualification (IQ), the Operational Qualification (OQ) and finally the Performance Qualification (PQ). This is now the simplest most expedient and most cost effective method of validating the climatic condition within any climatically controlled zone.
Each of these protocols are interactive and fully detailed.
VP, VRA, IQ, OQ, PQ.
This package consists of one of each of these documents.

Quantity  

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