Translation of Validation Summary Report DOMETIC MT8B Original report in German established by page 1
Table of Contents Description of the Validation Method...3 Test Readings MT8B at +10ºC Outside Temperature over 24 Hours...5 Performance Report...6 Chart...7 Test Readings MT8B at +32ºC Outside Temperature over 24 Hours...8 Performance Report...9 Chart...10 Test Readings MT8B "Maximum Cold Life" at +32ºC Outside Temperature...11 Performance Report...12 Chart...13 Test Readings MT8B "Maximum Cold Life" at +43ºC Outside Temperature...14 Performance Report...15 Chart...16 Validation Results...17 Validation Report MT8B...18 page 2
Validation of the Dometic MT8B Containment for the Transport of Blood Preparations 1 Introduction Object of the validation is the transport of erythrocyte concentrates (EC) in the Dometic MT8B transport container whilst maintaining the cold chain required for these preparations. The relevant German and European laws and directives require a storage temperature of 4ºC ± 2K or a transport temperature between 1ºC and 10ºC. The question of this validation is under what environmental conditions can erythrocyte concentrates be transported legally safely (and therefore without quality loss) over what period using the Dometic MT8B. 2 Basic Conditions 2.1 Description of System The transport containers of the Dometic Series MT8B are cooled passively by means of ice packs. The casings are manufactured by rotation process and receive an insulation of polyurethane foam. The complete functional unit always consists of an outer and an inner container. Summary of Individual Features Description MT8B Outer dimensions (HxWxD in mm) 435x590x290 Weight 7.0 kg Gross interior volume 18 litres Storage capacity (ECs at 270 ml each) 14 blood bags Number of ice packs (at 600 ml each) at 2ºC to +10ºC outside temperature None at +10ºC to +20ºC outside temperature 2 at outside temperature of above +20ºC 4 In order to compensate for statistical deviations and series variations, three different test patterns are used for this validation. 2.2 Ambient Temperatures Three ambient temperature ranges have been chosen for this validation: +10ºC, +32ºC, and +43ºC. As minimum or maximum limits, these temperature ranges cover more than 90% of the transport scenarios imaginable for Central Europe, including safety margins. 2.3 Charge For the 24 hours tests at +32ºC and +43ºC the typical lower charge limit of blood bags is chosen as charge. These low charge levels are more unstable, and the resulting test readings are very telling in respect to critical temperature ranges. With increasing charges the preparations' temperatures in the secondary container become increasingly stable. In fact this means a charge of 2 blood bags at 270 ml each. In order to determine the Maximum Cold Life at +32ºC and +43ºC, the maximum charge (i.e. 14 blood bags at 270 ml each) is used to determine the absolute performance limits. page 3
2.4 Time Frame The validation is carried out for a transport time of 24 hours. This period covers almost 100% of the genuine range of usage times for Central Europe. In addition, the time value "Maximum Cold Life" is determined for the ambient temperature ranges +32ºC and +43ºC. This value indicates the maximum amount of time the blood products can be held in the defined transport temperature ranges. 2.5 Check Points The recording of test readings is carried out at ten points in the interior container of the transport container: eight check points in the corners of the container, always at a distance of two centimeters of all three nearest side walls, one check point at the intersection of the diagonals, and another one inside a blood bag. If more than one blood bag is used, the bag containing the sensor is placed in the centre. Top View Front View The erythrocyte concentrate is substituted by a mixture consisting of 110 ml PAGGS-M and 160 ml HAES-Sterile 6% infusion solution. This mixture has very similar characteristics with respect to density and viscosity. Composelect by Fresenius HemoCare is used as blood bags. 2.6 Other The ice packs are frozen to a core temperature of between -18ºC and -22ºC by storing them for at least 24 hours at the corresponding temperature. Before the boxes are equipped with the cooling elements, the elements are allowed to defrost at room temperature for 15-30 minutes. Before starting a series of readings, the open (both interior and outer container are open) transport containers are exposed to the ambient temperature for at least six hours. page 4
Test Readings MT8B At an outside temperature of +10ºC over 24 hours page 5
Ambient temperature: +10ºC Number of measuring runs: 3 Duration of validation: 24 hours Validation Summary Report Dometic Series MT Performance Report for Dometic MT8B at +10ºC over 24 h Ambient temperature Measuring run 1 Measuring run 2 Measuring run 3 Accumulated Absolute Average temperature 10.13ºC 10.16ºC 10.14ºC 10.14ºC 10.14ºC Minimum value 8.22ºC 8.34ºC 8.33ºC 8.68ºC 8.22ºC Maximum value 12.10ºC 12.10ºC 12.09ºC 11.77ºC 12.10ºC Test readings MT8B Charge: 2 ECs at 270 ml each; two cooling elements at 600 ml each Temp 30 (air at top) Average temperature 4.52ºC 4.45ºC 4.66ºC 4.53ºC 4.66ºC Minimum value 4.07ºC 3.97ºC 4.17ºC 4.07ºC 4.17ºC Maximum value 19.57ºC 19.50ºC 19.70ºC 18.98ºC 19.70ºC Temp 31 (air at top) Average temperature 4.44ºC 4.37ºC 4.57ºC 4.45ºC 4.57ºC Minimum value 3.99ºC 3.87ºC 4.07ºC 3.99ºC 4.07ºC Maximum value 19.56ºC 19.44ºC 19.66ºC 18.88ºC 19.66ºC Temp 32 (air at top) Average temperature 4.39ºC 4.32ºC 4.52ºC 4.40ºC 4.52ºC Minimum value 3.91ºC 3.80ºC 4.02ºC 3.92ºC 4.02ºC Maximum value 19.45ºC 19.34ºC 19.59ºC 18.84ºC 19.59ºC Temp 33 (air at top) Average temperature 4.50ºC 4.43ºC 4.64ºC 4.51ºC 4.64 ºC Minimum value 4.03ºC 3.92ºC 4.13ºC 4.04ºC 4.13 ºC Maximum value 19.59ºC 19.51ºC 19.67ºC 18.97ºC 19.67 ºC Temp 34 (air at bottom) Average temperature 4.30ºC 4.23ºC 4.44ºC 4.32ºC 4.44ºC Minimum value 3.88ºC 3.77ºC 3.99ºC 3.88ºC 3.99ºC Maximum value 15.87ºC 15.72ºC 15.99ºC 15.17ºC 15.99ºC Temp 35 (air at bottom) Average temperature 4.43ºC 4.36ºC 4.57ºC 4.44ºC 4.57ºC Minimum value 3.98ºC 3.88ºC 4.09ºC 4.01ºC 4.09ºC Maximum value 16.00ºC 15.81ºC 16.14ºC 15.29ºC 16.14ºC Temp 36 (air at bottom) Average temperature 4.47ºC 4.40ºC 4.61ºC 4.48ºC 4.61ºC Minimum value 4.02ºC 3.91ºC 4.13ºC 4.04ºC 4.13ºC Maximum value 15.98ºC 15.94ºC 16.09ºC 15.31ºC 16.09ºC Temp 37 (air at bottom) Average temperature 4.39ºC 4.3 ºC 4.53ºC 4.40ºC 4.53ºC Minimum value 3.94ºC 3.83ºC 4.06ºC 3.95ºC 4.06ºC Maximum value 15.95ºC 15.86ºC 16.02ºC 15.28ºC 16.02ºC Temp 38 (air at centre) Average temperature 4.44ºC 4.37ºC 4.58ºC 4.45ºC 4.58ºC Minimum value 4.00ºC 3.89ºC 4.10ºC 4.01ºC 4.10ºC Maximum value 18.36ºC 18.25ºC 18.48ºC 17.69ºC 18.48ºC Temp 29 (EC) Initial temperature 3.73ºC 3.84ºC 3.85ºC 3.81ºC Average temperature 4.53ºC 4.47ºC 4.67ºC 4.56ºC 4.56ºC Minimum value 3.73ºC 3.84ºC 3.85ºC 3.81ºC 3.73ºC Maximum value 5.34ºC 5.35ºC 5.47ºC 5.38ºC 5.47ºC Final temperature 4.71ºC 4.76ºC 5.00ºC 4.82ºC Storage temperatures for ECs (2ºC - 6ºC) were maintained for: > 24:00:00 Transport temperatures for ECs (1ºC - 10ºC) were maintained for: > 24:00:00 page 6
Temperature chart for Dometic MT8B over 24 hours at an ambient temperature of 10 C (accumulated results) Ambient temperature MT8B Top Temp 30 MT8B Top Temp 31 MT8B Top Temp 32 MT8B Top Temp 33 MT8B Bottom Temp 34 MT8B Bottom Temp 35 MT8B Bottom Temp 36 MT8B Bottom Temp 37 MT8B Centre Temp 38 MT8B EC Temp 39 Time (hours) page 7
Test Readings MT8B At an outside temperature of +32ºC over 24 hours page 8
Ambient temperature: +32ºC Number of measuring runs: 3 Duration of validation: 24 hours Performance Report for Dometic MT8B at +32ºC over 24 h Ambient temperature Measuring run 1 Measuring run 2 Measuring run 3 Accumulated Absolute Average temperature 32.06ºC 32.07ºC 32.07ºC 32.07ºC 32.07ºC Minimum value 28.08ºC 27.50ºC 28.01ºC 27.87ºC 27.50ºC Maximum value 35.07ºC 35.07ºC 34.67ºC 34.65ºC 35.07ºC Test readings MT8B Charge: 2 ECs at 270 ml each; two cooling elements at 600 ml each Temp 30 (air at top) Average temperature 6.62ºC 6.71ºC 6.77ºC 6.69ºC 6.77ºC Minimum value 1.59ºC 1.69 ºC 1.75ºC 1.68ºC 1.75ºC Maximum value 15.49ºC 15.59 ºC 15.63ºC 14.73ºC 15.63ºC Temp 31 (air at top) Average temperature 6.54ºC 6.62ºC 6.69ºC 6.61ºC 6.69ºC Minimum value 1.51ºC 1.58ºC 1.65ºC 1.60ºC 1.65ºC Maximum value 15.46ºC 15.50ºC 15.61ºC 14.62ºC 15.61ºC Temp 32 (air at top) Average temperature 6.49ºC 6.57ºC 6.63ºC 6.56ºC 6.63ºC Minimum value 1.44ºC 1.55ºC 1.60ºC 1.54ºC 1.60ºC Maximum value 15.38ºC 15.46ºC 15.51ºC 14.61ºC 15.51ºC Temp 33 (air at top) Average temperature 6.60ºC 6.68ºC 6.75ºC 6.67ºC 6.75ºC Minimum value 1.56ºC 1.64ºC 1.70ºC 1.67ºC 1.70ºC Maximum value 15.51ºC 15.57ºC 15.62ºC 14.69ºC 15.62ºC Temp 34 (air at bottom) Average temperature 5.38ºC 5.46ºC 5.53ºC 5.45ºC 5.53ºC Minimum value 1.18ºC 1.25ºC 1.31ºC 1.26ºC 1.31ºC Maximum value 16.24ºC 16.26ºC 16.30ºC 15.56ºC 16.30ºC Temp 35 (air at bottom) Average temperature 5.50ºC 5.59ºC 5.65ºC 5.57ºC 5.65ºC Minimum value 1.27ºC 1.35ºC 1.42ºC 1.38ºC 1.42ºC Maximum value 16.30ºC 16.39ºC 16.45ºC 15.66ºC 16.45ºC Temp 36 (air at bottom) Average temperature 5.54ºC 5.63ºC 5.69ºC 5.61ºC 5.69ºC Minimum value 1.31ºC 1.42ºC 1.48ºC 1.41ºC 1.48ºC Maximum value 16.34ºC 16.44ºC 16.51ºC 15.70ºC 16.51ºC Temp 37 (air at bottom) Average temperature 5.46ºC 5.55ºC 5.61ºC 5.53ºC 5.61ºC Minimum value 1.22ºC 1.32ºC 1.36ºC 1.31ºC 1.36ºC Maximum value 16.30ºC 16.40ºC 16.44ºC 15.62ºC 16.44ºC Temp 38 (air at centre) Average temperature 6.20ºC 6.28ºC 6.35ºC 6.27ºC 6.35ºC Minimum value 1.46ºC 1.51ºC 1.60ºC 1.53ºC 1.60ºC Maximum value 15.77ºC 15.85ºC 15.87ºC 14.97ºC 15.87ºC Temp 29 (EC) Initial temperature 4.22ºC 3.99ºC 4.48ºC 4.23ºC Average temperature 6.01ºC 6.08ºC 6.16ºC 6.08ºC 6.08ºC Minimum value 3.04ºC 3.04ºC 3.22ºC 3.10ºC 3.04ºC Maximum value 7.48ºC 7.57ºC 7.62ºC 7.55ºC 7.62ºC Final temperature 7.48ºC 7.57ºC 7.62ºC 7.55ºC Storage temperatures for ECs (2ºC - 6ºC) were maintained for: > 08:25:00 Transport temperatures for ECs (1ºC - 10ºC) were maintained for: > 24:00:00 page 9
Temperature chart for Dometic MT8B over 24 hours at an ambient temperature of 32 C (accumulated results) Ambient temperature MT8B Top Temp 30 MT8B Top Temp 31 MT8B Top Temp 32 MT8B Top Temp 33 MT8B Bottom Temp 34 MT8B Bottom Temp 35 MT8B Bottom Temp 36 MT8B Bottom Temp 37 MT8B Centre Temp 38 MT8B EC Temp 39 Time (hours) page 10
Test Readings "Maximum Cold Life" MT8B At an outside temperature of +32ºC page 11
Performance Report for Dometic MT8B "Maximum Cold Life" at +32ºC Note: All statistical values refer to the period of time until the 10ºC limit in the EC is reached (Temp 39) Ambient temperature: +32ºC Number of measuring runs: 3 Ambient temperature Measuring run 1 Measuring run 2 Measuring run 3 Accumulated Absolute Average temperature 32.57ºC 32.57ºC 32.57ºC 32.57ºC 32.57ºC Minimum value 31.53ºC 31.53ºC 31.56ºC 31.65ºC 31.53ºC Maximum value 34.08ºC 33.98ºC 34.07ºC 33.80ºC 34.08ºC Test readings MT8B Charge: 14 ECs at 270 ml each; 4 cooling elements at 600 ml each Temp 30 (air at top) Average temperature 5.32ºC 5.58ºC 5.36ºC 5.42ºC 5.42ºC Minimum value 2.42ºC 2.81ºC 2.48ºC 2.59ºC 2.42ºC Maximum value 11.57ºC 11.51ºC 11.57ºC 11.52ºC 11.57ºC Temp 31 (air at top) Average temperature 5.23ºC 5.49ºC 5.27ºC 5.34ºC 5.33ºC Minimum value 2.31ºC 2.71ºC 2.38ºC 2.47ºC 2.31ºC Maximum value 11.47ºC 11.42ºC 11.45ºC 11.44ºC 11.47ºC Temp 32 (air at top) Average temperature 5.18ºC 5.45ºC 5.22ºC 5.29ºC 5.28ºC Minimum value 2.27ºC 2.65ºC 2.33ºC 2.44ºC 2.27ºC Maximum value 11.44ºC 11.38ºC 11.44ºC 11.36ºC 11.44ºC Temp 33 (air at top) Average temperature 5.29ºC 5.56ºC 5.33ºC 5.40ºC 5.39ºC Minimum value 2.38ºC 2.76ºC 2.44ºC 2.56ºC 2.38ºC Maximum value 11.53ºC 11.49ºC 11.55ºC 11.49ºC 11.55ºC Temp 34 (air at bottom) Average temperature 5.03ºC 5.32ºC 5.08ºC 5.14ºC 5.14ºC Minimum value 2.67ºC 3.06ºC 2.73ºC 2.83ºC 2.67ºC Maximum value 9.95ºC 9.80ºC 9.89ºC 9.86ºC 9.95ºC Temp 35 (air at bottom) Average temperature 5.16ºC 5.45ºC 5.20ºC 5.27ºC 5.27ºC Minimum value 2.78ºC 3.16ºC 2.83ºC 2.95ºC 2.78ºC Maximum value 10.02ºC 9.90ºC 10.01ºC 10.00ºC 10.02ºC Temp 36 (air at bottom) Average temperature 5.20ºC 5.49ºC 5.24ºC 5.31ºC 5.31ºC Minimum value 2.82ºC 3.21ºC 2.88ºC 3.00ºC 2.82ºC Maximum value 10.13ºC 10.00ºC 10.02ºC 10.05ºC 10.31ºC Temp 37 (air at bottom) Average temperature 5.12ºC 5.41ºC 5.16ºC 5.23ºC 5.23ºC Minimum value 2.74ºC 3.12ºC 2.80ºC 2.91ºC 2.74ºC Maximum value 9.98ºC 9.89ºC 9.94ºC 9.92ºC 9.98ºC Temp 38 (air at centre) Average temperature 5.21ºC 5.48ºC 5.26ºC 5.32ºC 5.32ºC Minimum value 2.49ºC 2.87ºC 2.56ºC 2.65ºC 2.49ºC Maximum value 11.02ºC 10.94ºC 10.99ºC 10.94ºC 11.02ºC Temp 29 (EC) Initial temperature 3.91ºC 3.82ºC 4.36ºC 4.03ºC Average temperature 5.02ºC 5.29ºC 5.09ºC 5.14ºC 5.13ºC Minimum value 2.79ºC 3.17ºC 2.86ºC 2.94ºC 2.79ºC Maximum value 10.01ºC 10.00ºC 10.00ºC 10.00ºC 10.01ºC Storage temperatures for ECs (2ºC - 6ºC) were maintained for: 30:30 Transport temperatures for ECs (1ºC - 10ºC) were maintained for: 57:02 page 12
Validation for Dometic MT8B Transport Container Maximum Cold Life at +32 C (accumulated results) Time (hours) Ambient temperature MT8B Top Temp 30 MT8B Top Temp 31 MT8B Top Temp 32 MT8B Top Temp 33 MT8B Bottom Temp 34 MT8B Bottom Temp 35 MT8B Bottom Temp 36 MT8B Bottom Temp 37 MT8B Centre Temp 38 MT8B EC Temp 39 page 13
Test Readings "Maximum Cold Life" MT8B At an outside temperature of +43ºC page 14
Performance Report for Dometic MT8B "Maximum Cold Life" at +43ºC Note: All statistical values refer to the period of time until the 10ºC limit in the EC is reached (Temp 39) Ambient temperature: +43ºC Number of measuring runs: 3 Ambient temperature Measuring run 1 Measuring run 2 Measuring run 3 Accumulated Absolute Average temperature 43.40ºC 43.39ºC 43.39ºC 43.39ºC 43.39ºC Minimum value 36.21ºC 36.44ºC 36.25ºC 36.30ºC 36.21ºC Maximum value 44.28ºC 44.34ºC 44.29ºC 44.25ºC 44.34ºC Test readings MT8B Charge: 14 ECs at 270 ml each; 4 cooling elements at 600 ml each Temp 30 (air at top) Average temperature 5.32ºC 5.58ºC 5.36ºC 5.42ºC 5.42ºC Minimum value 2.42ºC 2.81ºC 2.48ºC 2.59ºC 2.42ºC Maximum value 11.57ºC 11.51ºC 11.57ºC 11.52ºC 11.57ºC Temp 31 (air at top) Average temperature 5.23ºC 5.49ºC 5.27ºC 5.34ºC 5.33ºC Minimum value 2.31ºC 2.71ºC 2.38ºC 2.47ºC 2.31ºC Maximum value 11.47ºC 11.42ºC 11.45ºC 11.44ºC 11.47ºC Temp 32 (air at top) Average temperature 5.18ºC 5.45ºC 5.22ºC 5.29ºC 5.28ºC Minimum value 2.27ºC 2.65ºC 2.33ºC 2.44ºC 2.27ºC Maximum value 11.44ºC 11.38ºC 11.44ºC 11.36ºC 11.44ºC Temp 33 (air at top) Average temperature 5.29ºC 5.56ºC 5.33ºC 5.40ºC 5.39ºC Minimum value 2.38ºC 2.76ºC 2.44ºC 2.56ºC 2.38ºC Maximum value 11.53ºC 11.49ºC 11.55ºC 11.49ºC 11.55ºC Temp 34 (air at bottom) Average temperature 5.03ºC 5.32ºC 5.08ºC 5.14ºC 5.14ºC Minimum value 2.67ºC 3.06ºC 2.73ºC 2.83ºC 2.67ºC Maximum value 9.95ºC 9.80ºC 9.89ºC 9.86ºC 9.95ºC Temp 35 (air at bottom) Average temperature 5.16ºC 5.45ºC 5.20ºC 5.27ºC 5.27ºC Minimum value 2.78ºC 3.16ºC 2.83ºC 2.95ºC 2.78ºC Maximum value 10.02ºC 9.90ºC 10.01ºC 10.00ºC 10.02ºC Temp 36 (air at bottom) Average temperature 5.20ºC 5.49ºC 5.24ºC 5.31ºC 5.31ºC Minimum value 2.82ºC 3.21ºC 2.88ºC 3.00ºC 2.82ºC Maximum value 10.13ºC 10.00 ºC 10.02ºC 10.05ºC 10.31ºC Temp 37 (air at bottom) Average temperature 5.12ºC 5.41ºC 5.16ºC 5.23ºC 5.23ºC Minimum value 2.74ºC 3.12ºC 2.80ºC 2.91ºC 2.74ºC Maximum value 9.98ºC 9.89ºC 9.94ºC 9.92ºC 9.98ºC Temp 38 (air at centre) Average temperature 5.21ºC 5.48ºC 5.26ºC 5.32ºC 5.32ºC Minimum value 2.49ºC 2.87ºC 2.56ºC 2.65ºC 2.49ºC Maximum value 11.02ºC 10.94ºC 10.99ºC 10.94ºC 11.02ºC Temp 29 (EC) Initial temperature 3.91ºC 3.82ºC 4.36ºC 4.03ºC Average temperature 5.02ºC 5.29ºC 5.09ºC 5.14ºC 5.13ºC Minimum value 2.79ºC 3.17ºC 2.86ºC 2.94ºC 2.79ºC Maximum value 10.01ºC 10.00ºC 10.00ºC 10.00ºC 10.01ºC Storage temperatures for ECs (2ºC - 6ºC) were maintained for: 12:02 Transport temperatures for ECs (1ºC - 10ºC) were maintained for: 16:39 page 15
Validation for Dometic MT8B Transport Container Maximum Cold Life at +43 C (accumulated results) Time (hours) Ambient temperature MT8B Top Temp 30 MT8B Top Temp 31 MT8B Top Temp 32 MT8B Top Temp 33 MT8B Bottom Temp 34 MT8B Bottom Temp 35 MT8B Bottom Temp 36 MT8B Bottom Temp 37 MT8B Centre Temp 38 MT8B EC Temp 39 page 16
Validation Results page 17
Validation Report DOMETIC MT8B Object: Range of application: Results: Dometic MT8B Special transport container for the transport of blood preparations PROD-ID 958.4804.01; S/N 3090616, 3090625, 3090624 Transport of erythrocyte concentrates under Central European average climatic conditions Temp. +10 C over 24 h; 2 blood bags at 270 ml each; 2 icepacks at 600 ml each Ambient temperature Average: 10.14 C Absolute minimum: 8.68 C Absolute maximum: 11.77 C Blood bag core temperature Initial temperature: 3.81 C Final temperature: 4.82 C Maximum temperature: 5.38 C Minimum temperature: 3.81 C Temp. +32 C over 24 h; 2 blood bags at 270 ml each; 4 icepacks at 600 ml each Ambient temperature Average: 32.07 C Absolute minimum: 27.50 C Absolute maximum: 35.07 C Blood bag core temperature Initial temperature: 4.23 C Final temperature: 7.55 C Maximum temperature: 7.55 C Minimum temperature: 3.10 C Temp. +32 C "Max. Cold Life"; 14 blood bags at 270ml each; 4 icepacks at 600ml each Ambient temperature Average: 32.57 C Absolute minimum: 31.88 C Absolute maximum: 33.18 C Blood bag core temperature Initial temperature: 4.01 C Minimum temperature: 4.01 C Time until 6 C: 30h:30min Time until 10 C: 57h:02min Temp. +43 C "Max. Cold Life"; 14 blood bags at 270ml each; 4 icepacks at 600ml each Ambient temperature Average: 43.39 C Absolute minimum: 36.30 C Absolute maximum: 44.13 C Blood bag core temperature Initial temperature: 4.03 C Minimum temperature: 2.94 C Time until 6 C: 12h:02min Time until 10 C: 16h:39min page 18
Evaluation: The effect of the ambient temperature on the two erythrocyte concentrates stored in a transport container of the type Dometic MT8B over a period of 24 hours, is small. At an ambient temperature of +10 C, the preparations' core temperature within a MT8B charged with 2 blood bags at 270 ml each over more than 24 hours remains within the legally required storage temperature range. With the same charge and at an ambient temperature of +32 C, the storage temperature range of 2 C to 6 C is maintained for 8:25 hours and the transport temperature range is maintained for more than 24 hours. With a full charge of 14 blood bags at 270 ml each and at an ambient temperature of +32 C, the storage temperature range is maintained for over 30 hours and the transport temperature range for more than 57 hours, i.e. notably more than two days. Under extreme conditions, at an ambient temperature of +43 C and with a full charge, the storage temperatures are still maintained for more than 12 hours and the transport temperature range for over 16 hours. The passive design of the transport container makes the container entirely impervious to operating errors or power cuts under any environmental conditions if it is correctly configured. The casing of the transport container is extremely sturdy and almost entirely impervious against exterior forces, e.g. bumps and falls. Furthermore, it can be cleaned and disinfected easily and thoroughly. The interior does not feature any inaccessible corners and areas. Münster, 19th December 2003 page 19