Climate sensitive products have to be stored and transported within the specific climate conditions designed to ensure that they are preserved in a proper fashion. The main reason why we study a vehicle engaged in transportation of such goods is that we need to make sure that these conditions are met to ultimately preserve the integrity of these goods.
In case of transportation of medication as well as food products and logistics companies, there are some transport scenarios available from the climate standpoint.
For example in the case of pharmaceuricals, we need vechicles that typically maintain 2 temperature ranges:
2⁰C-8⁰C (refrigeration)
15⁰C-25⁰C (ambient)
The temperature mapping study will be explained below, explanation that applies to both to the OQ Temperature Mapping Study and the PQ real life Temperature Mapping Study.
One of the challenges is maintaining control over the temperature distribution across the storage space used for transport. Thus, potential changes of the temperature level due to various factors, will negatively impact the quality of the transported products.
A transport vechicle undergoes a process called IQ/OQ/PQ – which basically verifies and tests aspects pertaining to Installation and Maintenance of vechicle equipment and vechicle itself, among other things. A second venue involves the Operational Qualification, which involves a series of tests such as : Power On test, Power Off Test, Door Opening Tests for intervals such as 1 minute or 5 minutes. These tests are coupled as part of the OQ with an empty load temperature mapping session. And finally as part of the Performance Qualification tests, a real life / real transport temperature mapping is conducted under actual transport conditions to better understand based of various loads or driver and road specifics how the vehicle is able to maintain its climatic conditions in order to preserve the quality of the transported products.
In order to understand and determine the temperature distribution across the storage area of the transport vechicle, a temperature mapping study si mandatory. The temperature mapping study will help us and implicitly you, understand the different temperature levels in the vehicle, among other things determining hot and cold points.
This is the way a temperature mapping session is conducted:
1. Temperature dataloggers are installed within the storage space of the transport vehicle.
2. We determine how many dataloggers and each specific matrix through our own calculations and procedures, using as refference WHO Technical Report Series, No. 961, 2011, Technical Supplement 8 (May 2015), based on standard transportation storage spaces.
3. Based on the result of the studies involved, we provide a detailed report of the vechicle temperature levels under various situations.
4. Permanent temperature monitoring sensor locations are also provided for the transport vehicle within the complex qualification study.
Climate sensitive products have to be stored and transported within the specific climate conditions designed to ensure that they are preserved in a proper fashion. In this particular case we will be discussing Cold Rooms which are responsible for storing products that have to be kept within refrigeration temperature range, i.e. 2⁰C-8⁰C. The main reason why we study a Cold Room is that we need to make sure that the specific conditions are met to ultimately preserve the integrity of these goods.
A Cold Room undergoes a process called IQ/OQ/PQ – which basically verifies and tests aspects pertaining to Installation and Maintenance of Cold Room equipment as well as it’s build specs, among other things. A second venue involves the Operational Qualification, which involves a series of tests such as : Power On test, Power Off Test, Door Opening Tests for intervals such as 1 minute or 5 minutes. These tests are coupled as part of the OQ with an empty load temperature mapping session. And finally as part of the Performance Qualification tests, a real life / real usage temperature mapping is conducted under real storage conditions to better understand, based of various loads other specifics such as personnel pressence, typical open door times under real conditions, how the Cold Room is able to maintain its climatic conditions in order to preserve the quality of the stored products.
The temperature mapping study will be explained below, explanation that applies to both the OQ Temperature Mapping Study and the PQ real life Temperature Mapping Study.
One of the challenges is maintaining control over the temperature distribution across the Cold Room storage space, much like other storage spaces. Thus, potential changes of the temperature level due to various factors, will negatively impact the quality of the transported products. In order to understand and determine the temperature distribution across the storage area of the Cold Room, a temperature mapping study is mandatory. The temperature mapping study will help us and implicitly you, understand the different temperature levels in the Cold Room, among other things determining hot and cold points.
Here’s how a temperature mapping session is conducted:
1. Temperature dataloggers are installed within the storage space of the Cold Room.
2. We determine how many dataloggers and each specific matrix through our own calculations and procedures, using as refference WHO Technical Report Series, No. 961, 2011, Technical Supplement 8 (May 2015), based on standard Cold Room storage spaces.
3. Based on the result of the studies involved, we provide a detailed report of the Cold Room temperature levels under various situations.
4. Permanent temperature monitoring sensor locations are also provided for the Cold Room within the complex qualification study.
A specific aspect pertaining to the IQ/OQ/PQ processes of a Cold Room is that they can be done regardless of season, since they are installed in an already temperature controlled environment such as an ambient temperature warehouse. Thus they will not be exposed to outside conditions regardless of outside temperature conditions. This is generally valid for all fixed equipment that exists within a temperature controlled space, such as refrigerators, cold boxes that are permanently bolted in vehicles, etc.
As it is surely clear by now, climate sensitive products have to be stored and transported within the specific climate conditions designed to ensure that they are preserved in a proper fashion.
In this particular case we will be discussing Refrigeration Units such as: Refrigerators, Transport Cold Boxes, etc. which are responsible for storing products that have to be kept within refrigeration temperature range, i.e. 2⁰C-8⁰C.
The main reason why we study Refrigeration Units is that we need to make sure that the specific conditions are met to ultimately preserve the integrity of these goods.
In case of Refrigeration Units storage of medication for instance, there are some scenarios available from the climate standpoint.
Any Refrigeration Unit (mobile or fixed) undergoes a process called IQ/OQ/PQ – which basically verifies and tests aspects pertaining to Installation and Maintenance of the Refigeration Unit’s equipment as well as it’s device specs, among other things. A second venue involves the Operational Qualification, which involves a series of tests such as : Power On test, Power Off Test, Door/Lid Opening Tests for intervals such as 1 minute or 5 minutes. These tests are coupled as part of the OQ with an empty load temperature mapping session. And finally as part of the Performance Qualification tests, a real life / real usage temperature mapping is conducted under real storage conditions to better understand, based of various loads other specifics such as typical open door times under real conditions, how the Refrigeration Unit is able to maintain its climatic conditions in order to preserve the quality of the stored products.
The temperature mapping study will be explained below, valid for both the OQ Temperature Mapping Study and the PQ real life Temperature Mapping Study.
One of the challenges is maintaining control over the temperature distribution across the Refrigeration Unit’s storage space, much like other storage spaces. Regardless of the size, our experience has proven that even the smaller Refrigeration Boxes have the potential to have significant differences between various zones within its storage space. Thus, potential changes of the temperature level due to various factors, will negatively impact the quality of the transported products. In order to understand and determine the temperature distribution across the storage volume of the Refrigeration Unit, a temperature mapping study is mandatory.
The temperature mapping study will help us and implicitly you, understand the different temperature levels in the Refrigeration Unit, among other things determining hot and cold points.
The way a temperature mapping session is conducted is :
1. Temperature dataloggers are installed within the storage space of the Refrigeration Unit.
2. We determine how many dataloggers and each specific matrix through our own calculations and procedures, using as refference WHO Technical Report Series, No. 961, 2011, Technical Supplement 8 (May 2015), based on standard transportation storage spaces.
3. Based on the result of the studies involved, we provide a detailed report of the Refrigeration Unit’s temperature levels under various situations.
4. Permanent temperature monitoring sensor locations are also provided for the Refrigeration Unit within the complex qualification study.
When it comes to Refrigeration Units, the IQ/OQ/PQ processes can vary in procedure based on the type of Unit, from a mobility standpoint. Thus, fixed Refrigeration Units (such as Warehouse Refrigerators) will undergo IQ/OQ/PQ process regardless of season, as they are installed and will permanently remain in an already temperature controlled environment, i.e the warehouse with controlled ambient temperature. However, certain Refrigeration Units are mobile, and will implicitly have the potential to be exposed to outside uncontrolled temperatures. Such units (ex: Mobile Active Cold Boxes) will undergo an IQ/OQ/PQ process performed in the two extreme seasons (summer and winter) from a temperature standpoint.
HVAC is obviously an acronym. It simply means heat, ventilation and air conditioning. HVAC refers to the different systems used for moving air between indoor and outdoor areas, along with heating and cooling both residential and commercial buildings.
Surely, climate sensitive products have to be stored and transported within the specific climate conditions designed to ensure that they are preserved in a proper fashion. These climate conditions are maintained by HVAC Systems. We could be going into a lot of detail, about how HVAC System Design is a sub-discipline of mechanical engineering, based on the principles of thermodynamics, fluid mechanics and heat transfer. But you can find all this stuff on Wikipedia.
Instead, we are going to focus on explaining what we do to validate all aspects of warehouse HVAC Systems, starting from Installation Qualification (IQ), and moving on to Operational Qualification (OQ). Last but never least, we will explain about Performance Qualification (PQ) for such systems.
All HVAC Systems responsible for maintaining proper climate conditions for temperature/RH sensitive products undergo a process called IQ/OQ/PQ.
IQ typically verifies how the HVAC components were installed and if the installation is executed according to product installation specs. All documents are checked, including the existence of proper manuals, installation documentation, maintenance documentation and periodicity, calibration of relevant system components, as well as plans and schedules for calibration.
OQ is responsible for a sequence of tests performed on the HVAC System, such as: maintaining proper functioning parameters for a specific period of time and system responsiveness to changes. System parameters are modified actively during testing in order to test that the settings apply within a reasonable timeframe. These tests are performed prior to using the HVAC Systems in real life storage facilities.
The “questions we ask” are:
Is the HVAC system able to maintain the set temperature over a specific period of time?
Is the HVAC system able to keep it’s ventilation speed over a specific period of time?
How long does it take for the HVAC system to reach the set parameters, such as a temperature setpoint?
How swiftly does the HVAC system respond to ventilation speed user adjustments?
PQ is in a certain sense OQ’s cousin when it comes to testing. Similar tests are performed, similar questions are asked.
This time however we’re talking real life testing, with systems actually functioning in a storage space with products in it.
Assuming that the OQ phase was a succes, PQ now plans to test what happens in actual real conditions which, we all know, can offer occasional surprises that no one really needs when storing climate sensitive products, such as medication.
That is why some of the tests we have done during the OQ phase, we now redo for a longer period of time. We make sure that all areas of the storage facility are properly “taken care of”. This is in part achieved by HVAC PQ testing, coupled with Storage Space Temperature and RH Mapping results, For more details about T/RH Mapping, please see our Mapping section.