IE20040760A1 - Refrigeration vehicle - Google Patents

Abstract

A refrigeraton vehicle (10) for use in transporting temperature sensitive products such that the product is transferred between locations without being compromised. The refrigeration vehicle comprising a refrigeration area (42) operable within a required temperature range by at least two refrigeration units (12,14), a first refrigeration unit (12) being operable by the vehicle's power supply (1) and a second refrigeration unit (14) being operable by both a battery (2) and mains supply (6), at least one detection probe (11,15,16,17) for monitoring the temperature of the refrigeration area, a monitoring unit (21) for recording and displaying the temperature data form the detection probe (11,15,16,17), and an alarm unit which is triggered when the temperature of the refrigeration area (42) reaches a pre-set minimum or maximum temperature on the monitoring unit (21). The refrigeration vehicle (10) can further comprise a global positioning system (GPS) (23), which facilitates remote monitoring of the position of the vehicle and/or recording and displaying the analysis of the temperature detection probes. <Figure 3>

Description

The present invention relates to a refrigeration vehicle, in particular to a refrigeration vehicle for use in transporting temperature sensitive products such as, but not limited to, vaccines, blood factor concentrates and other pharmaceutical products.

In recent years there has been growing concern surrounding the maintenance of quality in relation to cold-chain storage and distribution of pharmaceutical products especially specialist pharmaceutical products such as biologicals, blood factor concentrates and vaccines.

There is growing importance in the pharmaceutical and biotechnology industry in Ireland, and indeed worldwide, when transporting products that are temperature sensitive for example 2°- 8°C. Many of the newer higher technological products require temperature control during storage and transportation. In parallel with this, the regulatory authorities are stepping up their inspections to ensure that pharmaceutical companies and wholesalers are following good distribution practice (GDP). The Medicines Control Agency (MCA) in the United Kingdom point out that temperature control and monitoring of warehouse storage and the cold chain are the highest areas of critical and major deficiencies found at audit in 2001. Temperature control and monitoring comprise more than one-third of all critical and major deficiencies found in that audit.

Validation is important in most industries, but is essential in the pharmaceutical and biological industries. It is absolutely necessary to demonstrate accurately and reproducibly that the pharmaceutical products supplied to the end users are of the highest standard and that the condition of said products have not deteriorated in any way from production through to use by the end users. Previous systems have failed to provide any such means or assurances.

It is with this backdrop that the inventor has developed a process in a refrigeration vehicle, which will give the pharmaceutical companies, regulatory bodies and health authorities every confidence that the temperature sensitive products are verifiably maintained during the transportation stage. It ensures that all the key systems have a backup source that can be relied upon if the main source fails.

Accordingly, the present invention provides a refrigeration vehicle comprising IE 04 0 76 0 (a) a refrigeration area operable within a required temperature range by at least two refrigeration units a first refrigeration unit operable by the vehicle’s power supply and a second refrigeration unit operable by both a battery and mains electrical supply, (b) at least one detection probe for monitoring the temperature of the refrigeration area, (c) a monitoring unit for recording and displaying the temperature data from the detection probe, and (d) an alarm unit which is triggered when the temperature of the refrigeration unit reaches a pre-set minimum or maximum temperature on the monitoring unit.

Ideally the first refrigeration unit comprises a primary refrigeration unit and the second refrigeration unit comprises an auxiliary refrigeration unit.

Preferably the refrigeration unit operates within the range of 2°C to 8°C or any appropriate temperature range for the products Preferably the alarm unit is triggered when the temperature of the refrigeration unit reaches a pre-set minimum temperature, for example 3°C or pre-set maximum temperature, for example 7°C. Ideally the alarm unit is triggerable when the temperature of the refrigeration area reaches within 1°C above the minimum temperature within the required temperature range or 1°C below the maximum temperature within the required temperature range. This enables corrective action to be taken quickly before the temperature of the refrigeration unit reaches the minimum or maximum temperature within the preferred range of operation, in this case 2°C to 8°C. Optionally a second alarm may be triggered when the temperature reaches the minimum or maximum temperature within the preferred range of operation.

Conveniently the refrigeration vehicle further comprises a Global Positioning System (GPS) which facilitates remote monitoring of the location of the refrigeration vehicle and/or recording and displaying the analysis of the temperature detection probes. Ideally the detection probes comprises a plurality of air-temperature probes and at least one product probe wherein the air-temperature probes detect the temperature of the air within the refrigeration unit and the product probe mimics a packaged product. Preferably the product probe comprises a temperature probe packaged as a product and placed in a product container thereby mimicking a real product. The temperature of the product probe is monitored and is treated as being analogous to the temperature of an actual product.

Optionally, throughout a vehicles journey the temperature data can be downloaded through a Data Carrier Unit (DCU) device at a remote location for analysis and storage.

Conveniently, the GPS provides a back-up to this system.

Ideally the GPS can alert the office computer to temperature spikes and send a text messages to an “on call” staff member. This is convenient if the staff member for example the driver of the vehicle is delivering a product and is therefore not in the vehicle when the alarm is triggered.

Optionally the vehicle also comprises a battery powered heating system in case of freezing ambient temperatures. Conveniently this system can be incorporated into the refrigeration units.

Preferably the refrigeration area has extra insulation to that used normally on refrigeration vehicles, typically the insulation of the refrigeration area of the present invention is between 8cm to 12cm. This has the benefit of increasing the hold-over time in case of a total systems failure. Where the hold-over time is defined as the time for product to go outside the preferred temperature range when the refrigeration units are disengaged. Optionally the insulation provided for the refrigeration area of the vehicle can be of a temporary nature and can be removed to fit other vehicles.

Advantageously the refrigeration vehicle of the present invention could further include heavy duty plastic insulating barrier strips at the entrance to the refrigeration area thereby preventing a rapid temperature drop when the door to the refrigeration area is opened.

In other embodiments of the vehicle, the vehicle can be fitted with a separate ambient section, which includes a heater unit and a refrigeration unit to maintain products at an alternative temperature range that is for example, between 18°C to 25°C. Alternatively the vehicle may include a freezer section to maintain products between for example, 24°C to -30°C.

IE 0 4 0 76 0 Ideally in the preferred embodiment of the invention, the vehicle includes two refrigeration units, the first refrigeration unit being operated from the engine mains supply and the second refrigeration unit being operated by both a battery and mains supply, to cover driver breaks and engine failure.

The preferred embodiment of the invention further includes an alarm unit, three airtemperature probes and one product probe to constantly monitor and record temperature of the air within the refrigeration, the data being displayed on a visual and/or temperature monitor in the cab of the vehicle. Also included in the preferred embodiment of the invention is a Global Positioning Systems (GPS), which offers security in terms of vehicle position and also remote monitoring of “real time” and historical temperature recording from the office. Conveniently the records/data created by monitoring the temperature can be downloaded to a remote computer via the GPS.

The invention will hereinafter be more particularly described with reference to the accompanying drawings, which show by the way of example only, one embodiment of a refrigeration vehicle according to the invention.

In the drawings: Figure 1 is a side view of the vehicle; Figure 2 is an end view of the vehicle with the rears door of the vehicle and the door of the refrigeration vehicle in an open position; and Figure 3 is a side cross-sectional view of the vehicle.

Referring to Figures 1, 2 and 3, the refrigeration vehicle 10 comprises two refrigerating units 12 (Main Unit) and 14 (Back-up Unit) mounted on the roof of the vehicle. Each refrigeration unit comprises an evaporator 12a and 14a a condenser 12b and 14c. The main refrigerating unit 12 is connected and powered by the engine 1. The back-up refrigerating unit 14 is powered by the auxiliary battery 2 and can also be powered from a mains electricity supply 6. The auxiliary battery 2 is linked to the engine battery 1 and is recharged via an alternator 4 when the vehicle 10 is in motion.

The back-up refrigeration unit 14 is switched on by the driver when the engine is switched off. Alternatively the back up refrigeration unit 14 can be switched on while the main refrigeration unit 12 is in operation. Generally this will only occur when the external ambient temperature is very high and auxiliary cooling is required.

An isolation relay switch 5 is activated when the vehicle 10 is not in use to prevent power being drained from the main battery unit of the engine 1.

IE 0 4 0 76 0 Audio and visual alarms are built into the dashboard 20 of the vehicle. A global positioning system 23 is built into the vehicle 10, the aerial 22 of the GPS being positioned on the roof of the vehicle 10. The GPS 23 is linked to a temperature monitoring unit 21 which enables the driver of the vehicle to monitor the temperature at all times. The vehicle is tracked by a remote computer using the GPS 23 and Global Positioning System tracking technology which is linked to a data communication unit such as a GSM modem. Furthermore, the temperature data generated during a vehicles journey can be downloaded through a Data Carrier Unit (DCU) device and loaded to a remote computer for analysis and storage. Both systems allow interrogation of the vehicle positioning and temperature data in real-time or historic or a combination of both. This is performed on the GPS 23 by means of a GSM communication from the remote computer to the host unit in the vehicle. Any untoward event relating to temperature is signalled through the data communication unit back to base. The remote computer is then capable of SMS messaging to alert to an on-call staff member such as the driver of the vehicle or a technical engineer.

The refrigeration area 42 has a number of probes 11, 15, 16 and 17 positioned within it. There are three air probes, 15, 16 and 17 respectively and one product probe 11. The product probe 11 is packaged as if a real product and placed in a product container within the refrigeration area 42, thereby mimicking a real product. Each of the probes 11,15,16 and 17 are connected to the monitoring unit 23 within the cab of the vehicle 10.

The door 40 of the refrigeration unit is also connected to the monitoring unit 21, thus providing an indication every time the door 40 is opened and closed via switch 18.

As can be seen in Figure 2, when the rear doors 30 of the vehicle are opened, another door 40 of the refrigeration area 42 has to be opened to gain access to the area. The lg 040760 fridge door 40 is purpose built for extra insulation and extra insulation 44, approximately, double the normal, is provided for the refrigeration area 42.

Example of Validation Testing of the Refrigeration Vehicle Performance & Operational Qualification Example Protocol Currently, the main refrigeration unit on the vehicle is a Carrier Transicold Xarios 200 unit 12, supported by a Carrier Transicold Basic 700 back up refrigeration unit 14. Any suitable refrigeration unit known to a person skilled in the art can be used. The equipment was designed to ensure operating temperatures can be maintained over pre-set ranges at all times eg 2°-8°C.

The monitoring unit was a Tanscan 2 temperature recorder with four temperature probes (three air 15,16 and 17 and one product 11) in the refrigeration area.

The refrigeration vehicle 10 is tested under normal operating conditions. Each test taking at least 4 hours, monitoring every 10 mins. There are eight test locations in the refrigeration area 42. The position of the test probes are identified on Temperature Probe Location Forms. Each location is tested for 4 hours with the fridge empty (one test) and 4 hours with the fridge loaded (second test). Two operational 6 hour tests are then be carried out, thereby testing the vehicle 10 under full operational conditions. The hot and cold spots are then analysed and the final position of the probes for general use decided. Alarm tests are also carried out at both high and low set points.

Example Acceptance Criteria The fridges should show operational temperatures of within the set range appropriate to the product requirements at all times. In this example, the temperature range is 2°-8°C.

Any test that gives results outside the required limits is analysed and the reason for the deviation found. This is then corrected before further testing commences.

Example Report A Cold Chain Service is offered to Health Boards, Hospitals and Pharmaceutical companies. The service involves refrigerated storage of vaccines at an appropriate IE 0 4 076 Q warehouse, and refrigerated nationwide transport to deliver direct to health boards and/or hospitals.

All refrigerators used and the transport systems are subject to validation. Each refrigeration vehicle and transport procedures will are tested initially in both winter and summer conditions and then on an annual basis thereafter. Daily analysis occurs during normal operation of the vehicle 10.

Aims of Validation Most regulatory authorities require that validation and requalification processes should establish and provide documentary evidence as out lined below: • The premises, the facilities, the equipment and the processes have been designed in accordance with the requirements of current G.D.P. (Good Distribution Practice.) • The equipment has been installed in compliance with their design specifications.

The aim of this validation process will be to show that the facilities and equipment operate in accordance with their design specifications. This Process Qualification (P.Q) will show that the equipment and processes operate to a consistent and reliable standard, maintaining the integrity of the product at all times.

Any aspect of, including significant changes to, the vehicle, the equipment or the processes, which may affect the quality of the product, directly or indirectly, should be qualified and validated.

Requalification will occur annually or at another time where the changes outlined above require it. Appropriate documentary evidence will be carried out with each validation or requalification. Initial validation testing will be repeated during the winter to show testing through the two extremes of temperatures. The initial validation work will be carried during the summer.

The vehicle used is a Land Cruiser,. The main refrigeration unit is a Carrier Transicold Xarios 200 unit, supported by a Carrier Transicold Basic 700 as the stand by unit.

IE 0 4 0 7 6 0 Temperature Mapping Instuments A Transcan 2 temperature recorder was used for the testing. The unit situated on the glove box is unit R19165 has three air and one product temperature probes attached.

Example Methodology The aim of this validation is to prove that the refrigeration process can maintain the product between 2° - 8° C continuously. From loading of the van, through the journey, to delivery to the customer. Temperature mapping of all areas of the fridges are needed to confirm that irrespective of where a product is placed, the storage temperature requirements will be met. The number and location of the temperature probes will be determined for each appliance. The final positions will be related to the control probe, cooling coils and fan positions. The final positions of the probes 11, 15, 16 and 17 are shown in Figure 3.

A range of tests A to F are described below, showing the testing and operational functionality of the fridge.

• The test equipment is set up and calibrated against the reference temperature standard. The equipment is rechecked against the calibration reference at the end of the testing schedule.

• The temperature probes are positioned in their exact locations according to the protocol test diagrams . • 8 testing locations are used for the fridge. (Not shown) • A test sheet is completed for each day of testing, recording exactly what was done and making any comments required.

A) Fridge Setting Tests The temperature profile of both refrigeration units were assessed at settings 4 and 5. This allows the optimum setting to be chosen, for each unit.

B) Unloaded and Loaded Tests The system is closed to personnel access and the test period commences once the environmental conditions have stabilised in the test area. The testing period is 4 hours. The van will be tested both empty and loaded, with the fridge set at established set point. The testing schedule involves two unloaded tests and two loaded tests to be carried out, ΙΗ 0 4 0 76 0 with probes in the positions designated on the location chart. The product probe was placed in different areas of the van for each test.

C) Operational Tests The fridge will then be tested for a 6 hour period in its daily operation mode. This will involve actual replication of the daily working processes. The test will start with the van being loaded and the boxes will be removed gradually as the testing progresses. This will involve opening the door for 30 second intervals at least fifteen times at irregular intervals during the testing procedure. The back-up unit will be used during the test as it would be in the normal daily system. That is, it will be switched on when the van has to be left for any long period of time i.e. over lunch-time or when the van cannot be parked close to the surgery.

The results will be analysed to assess the position of the cold and hot spots within the fridges. The location of the 3 static air probes and the product probe will then be chosen to ensure the areas of largest fluctuation are monitored.

D) Door Open/Closed Tests The fridge was allowed to stabilise at 4-6 °C and the door was opened for varying time periods and then closed; this was repeated 8 times over a two hour period.

E) Warming Warming Test: The fridge will be stabilised at 4°C and 6°C, and the refrigeration units switched off. The time for the product to reach 8°C will be monitored.

F) Alarm Tests Alarm tests will be carried out at both high and low set points. This will be carried out by warming and cooling the individual probes and watching the transcan units to time when they visually flash and the alarm sounds G) Plug in Operation The main unit was switched on, and tested over a 12 hour period, to ensure it can maintain the required 2° to 8°C when plugged in overnight.

Example TEST RESULTS IE 0 4 0 78 0 A) Fridge Settings A) i) Fridge setting at 4 Main Unit: The probes were between 4.2 and 6.5°C Back Up Unit: The probes were between 4.5 and 5.4 °C.

A) ii) Fridge Setting at 5 Main Unit: The probes were between 4.8 and 7.0°C Back up Unit: The probes were between 5.5 and 6.5°C.

With the setting at 3, the temperatures were running very close to the 3°C parameter. Settings 4 and 5, operated more centrally, with setting 4 giving the better range around the 4°C to 5°C.

Therefore setting 4 was chosen as the optimal operational setting.

B) Unloaded and Loaded Testing Throughout all these tests the fridge was set at 4. The ambient temperature ranged from 17 °C to 30 °C through these tests.

Summary of Temperature Mapping loaded and unloaded. All numbers on the tables are in °C units.

Location Unloaded 1 Unloaded 2 Loaded 1 Loaded 2 Min Max Ave Min Max Ave Min Max Ave Min Max Ave Product Probe 5.4 7.2 5.9 4.6 7.2 5.1 5.2 6.8 6.2 5.1 6.0 5.4 Air 1 4.1 6.4 5.3 3.9 6.2 5.1 3.5 5.8 4.5 4.3 6.0 5.1 Air 2 3.0 6.0 4.8 3.6 5.9 4.9 3.6 5.9 4.7 3.3 5.8 4.6 Air 3 3.7 6.9 5.2 3.7 6.5 5.1 3.6 6.7 4.7 3.9 6.4 4.9 AirT2 4.7 6.5 5.8 4.1 7.4 5.6 4.8 6.9 5.6 3.7 7.5 5.5 AirT3 4.5 6.3 5.4 3.9 6.4 5.3 6.7 8.0 7.1 5.0 7.2 6.0 Air T4 4.5 5.9 5.3 3.9 6.7 5.2 4.0 6.2 5.0 3.3 6.8 5.0 IE 0 4 0 78 Ο Hot Spots The hottest area is position T2 in two of the four tests.

Cold Spots The coldest area in three tests was position Air 2.

During these tests the boxed product probe was placed in all areas of the fridge. Each 10 time the temperature recorded once stabilised, was between 4.6°C and 6.8°C. No matter where positioned in the fridge the probe was maintained within the required levels.

C) Operational Tests Summary of Temperature Mapping - Operational Runs Location Run 1 Run 2 Run 3 Min Max Ave Min Max Ave Min Max Ave Product Probe 5.2 6.9 5.6 5.1 7.3 5.5 4.8 7.9 5.4 Air 2 4.5 6.8 5.4 4.6 6.2 5.2 3.5 6.6 4.9 Air 3 3.7 6.2 4.9 3.4 7.3 5.0 2.8 6.0 4.5 Air 4 3.9 6.8 5.2 3.5 7.1 5.9 2.5 8.0 5.1 AirT2 4.3 6.7 5.4 3.8 6.9 5.4 4.0 8.3 5.8 AirT3 5.1 6.7 6.0 4.9 7.9 5.9 4.5 6.8 5.4 AirT4 3.8 6.3 5.0 3.6 6.2 5.0 3.6 7.7 5.2 The product probe was placed towards the back of the load on Run 1, in the middle on run 2 and towards the rear of the van on Run 3.

Once stabilised the product probe was maintained between 4.8°C and 6°C.

The coldest spot was in positions Air 3 and Air 4.

The warmest spot was T2.

IE 04 0 76 0 One probe went outside the 2-8°C parameters to 8.3°C for less than 5 minutes, the product probe remained below 6°C through this peak.

D) Door Open/Closed Tests The van has a double rear door and inside is the single door of the refrigeration unit. The fridge was allowed to stabilise at 4-5 °C and the door was opened for varying time periods ranging from 15 seconds to one minute and then closed. This was repeated 8 times over a one hour period.

The test was carried out with the main refrigeration unit and the backup unit working alternately. The unit in operation did not affect the temperatures recorded.

E) Warming Tests These tests were carried out, to simulate the warming scenarios if both refrigeration units failed.

Warming The tables show the time it takes for the product probe to reach 8°C.

Test Time for Product to reach 8°C From Engine Switch off From 5.5°C Ambient 23°C (Outside) 1 hour Unloaded From 4.5°C Ambient 23°C (Outside) 1 hour Loaded On a warm summers day 23°C to 25°C it took one hour for the product probe to reach 8°C.

F) Alarm Tests All the alarms registered visually by the number on the transcan unit flashing visually and by sounding the buzzer, at both the high and low alarm set points. Ιζ 040760 G) Back-up Unit The back up unit was plugged into the mains and operated for 6 hours on three separate tests Location Run 1 Run 2 Run 3 Min Max Ave Min Max Ave Min Max Ave Product Probe 5.2 5.6 5.4 5.2 6.1 5.4 5.2 7.3 5.7 Air 2 4.7 5.1 4.9 4.4 6.8 5.1 3.3 5.1 4.1 Air 3 4.8 5.4 5.0 4.4 6.7 5.1 3.5 4.9 4.2 Air 4 5.0 5.4 5.2 4.5 6.9 5.3 3.5 5.7 4.3 AirT2 4.4 6.9 4.8 4.4 6.9 4.9 4.7 6.4 5.4 AirT3 5.0 7.2 5.2 5.1 6.9 5.3 4.9 6.3 5.6 AirT4 4.0 6.1 4.6 4.1 6.9 4.8 4.0 5.8 4.7 The probes showing the highest and lowest readings were those from the second transcan unit, probes T2, T3,T4.

Deviations During all the test runs there was only one deviation outside the 2- 8 °C limits, the probe reached 8.3 °C for less than 5 minutes and had no effect on the product probe.

Discussion The optimal fridge setting of 4 was established during tests A.

All tests where then carried out with the fridges set at 4, which maintained the required temperatures. The probe placement tests show there is little variation in temperature around the fridge, even when loaded. The location of the product probe box within the load showed little variation and was maintained well within the required limits, in all locations.

For the operational tests, product was introduced into the fridge at different temperatures, and each time the product probe stabilised to between 5°C and 6°C,even when at different ends of the van. £ 0 4 0 76 0 The door open/closed tests showed that the one door could be left open for at least 1 minute and still remain within the temperature requirements. In reality it will be rare that the door is open for this length of time. In day to day operation the door will be opened for about 15 to 30 seconds.

The alarm parameters are set 1 °C inside the required 2-8°C temperature range, and will alarm if the temperature is outside 3-7°C for more than 2 minutes. The alarm tests proved that they operate exactly as set. A second alarm parameter is set at 2 and 8°C to alarm immediately.

The warming studies showed that in the event of both units failing, there would be about one hour, on a warm summers day, before the product temperature would exceed the required levels, ensuring some time to deal with the cause of the problem, that activated the alarm.

Cooling studies will need to be carried out, once the winter temperatures drop to ensure optimal operation during exceptional cold spells. An exceptional cold spell did not occur whilst this testing was being carried out.

Example Recommendations The fridge needs to be allowed to stabilise for at least 15 minutes before it can be loaded. Strict loading practices must be adhered to. Not only for loading pattern, but also to ensure both the fridge and the monitors are active and operating. A daily record sheet must be signed off by both the driver and warehouse manger to ensure correct practices. All products accepted for transportation must be between 2 and 8°C, at loading. The transcan display should be observed at regular intervals during the journey and at the end of each journey the temperature data must be downloaded and analysed.

It is to be understood that the invention is not limited to the specific details described herein, which are given by way of example only and that various modifications and alterations are possible without departing from the invention.

Claims (20)

1. A refrigeration vehicle comprising; (a) a refrigeration area operable within a required temperature range by at least two refrigeration units, a first refrigeration unit operable by the vehicle’s power supply and a second refrigeration unit operable by both a battery and mains electrical supply, (b) at least one detection probe for monitoring the temperature of the refrigeration area, (c) a monitoring unit for recording and displaying the temperature data from the detection probe, and (d) an alarm unit is triggerable when the temperature of the refrigeration area reaches a pre-set minimum or maximum temperature on the monitoring unit.

2. A refrigeration vehicle as claimed in Claim 1, wherein the first refrigeration unit comprises a primary refrigeration unit and the second refrigeration unit comprises an auxiliary refrigeration unit.

3. A refrigeration vehicle as claimed in Claim 1 or Claim 2, wherein the detection probe comprises a plurality of air-temperature probes and at least one product probe.

4. A refrigeration vehicle as claimed in Claim 3, wherein the product probe comprises a temperature probe packaged as a product and placed in a product container thereby mimifeklng a real product.

5. A refrigeration v^^icle as claimed in any one of the preceding claims, wherein the alarm unit comprises at least one alarm triggerable when the temperature of the refrigeration area reaches the pre-set minimum or maximum temperature within the required operable temperature range.

6. A refrigeration vehicle as claimed in Claim 5, wherein the alarm unit is triggerable when the temperature of the refrigeration area reaches within 1°C above the minimum temperature within the required temperature range or 1°C below the maximum temperature within the required temperature range. £ 0 4 0 76 0

7. A refrigeration vehicle as claimed in Claim 6, wherein the alarm unit comprises a second alarm which is triggerable when the temperature of the refrigeration area reaches the minimum temperature within the required temperature range or the maximum temperature within the required temperature range.

8. A refrigeration vehicle as claimed in any one of the preceding claims, including a Global Positioning System (GPS).

9. A refrigeration vehicle as claimed in Claim 8, wherein the Global Positioning System (GPS) facilitates remote monitoring of the location of the vehicle.

10. A refrigeration vehicle as claimed in Claim 8 or Claim 9, wherein the Global Positioning System (GPS) facilitates remote monitoring of the analysis from the detection probe.

11. A refrigeration vehicle as claimed in any one of Claim 8, Claim 9 or Claim 10, wherein the Global Positioning System (GPS) signals the remote computer to temperature spikes and enables a text messages to be sent to a remote site.

12. A refrigeration vehicle as claimed in any one of the preceding claims, including a battery powered heating system.

13. A refrigeration vehicle as claimed in Claim 12, wherein the battery powered heating system is incorporated into the refrigeration area.

14. A refrigeration vehicle as claimed in any one of the preceding claims, wherein the , refrigeration area is enclosed with a layer or layers of insulation material.

15. A refrigeration vehicle as claimed in Claim 14 wherein the insulation is readily removable from the refrigeration area.

16. A refrigeration vehicle as claimed in any one of the preceding claims, including heavy duty insulating barrier strips at the entrance to the refrigeration area.

17. A refrigeration vehicle as claimed in any one of the preceding claims, wherein the refrigeration units are operable within the preferred range of 2°C to 8°C. IE 0 4 0 76 0

18. A refrigeration vehicle as claimed in any one of the preceding claims, including a separate ambient section, which includes a heater unit and a refrigeration unit to maintain products at ambient temperatures that is, for example, between 18°C to 25°C.

19. A refrigeration vehicle as claimed in any one of the preceding claims including a separate freezer section to maintain products between, for example, -24°C to -30°C.

20. A refrigeration vehicle substantially as herein described with reference to and as shown 10 in the accompanying drawings. MACLACHLAN & DONALDSON Applicant’s Agents 47 Merrion Square 15 DUBLIN 2 £ 040760 1/3 FIGURE 1 Ο £ 040760 2/3 FIGURE 2 IE 0 4 0 76 0 3/3 12b A 12a / 7 14b A 14a o FIGURE 3