DK177203B1

DK177203B1 - Test method for a liquid purification and/or filtration device

Info

Publication number: DK177203B1
Application number: DKPA201070235A
Authority: DK
Inventors: Roelie Bottema; Jean-Luc Madier De Champvermeil; Sebastien Gouin; Michael Stanley Pedersen; Mikkel Vestergaard Frandsen; Daniel Frauchiger
Original assignee: Vestergaard Frandsen Sa
Priority date: 2010-06-01
Filing date: 2010-06-01
Publication date: 2012-06-04
Also published as: WO2011150934A1; DK201070235A

Abstract

A test method for checking the stability performance of water filtration devices. The test is airning for a global standard including sirnulations for truck drive, drop of a bulk box containing the device, weathering and aging of the device, drop of a single device, irnpact sirnulations, static loads, long term use of moving parts of the device and pres sure stability.

Description

i DK 177203 B1

Test method for a liquid purification and/or filtration device

FIELD OF THE INVENTION

The present invention relates to stability testing of a fluid purification and/or filtration device, including water purifiers with chemical and/or physical filtration steps as well 5 as filtration devices used for medical applications, for example used for cell separation and dialysis.

BACKGROUND OF THE INVENTION

10 Membrane filtration is used in water purification, for example as published in international patent application W02009/019592 by Vestergaard SA, as well as in medical cell separation, for example as disclosed in international patent application W095/13829 by Braun Melsungen. Despite different purposes, the filtration principles, for example when using hollow fibre assemblies, are similar. The proper func-15 tioning of the filtration devices is essential in both fields, as a defective cell separation device or dialysis filter can be fatal for the patient, as well as a defective water purification device can be fatal for the user in areas, where the water contains pathogens. Quality criteria have to be high in both cases, and it should be assured that the filtration devices can fulfil the promised performance standards not only at the factory site 20 but also after delivery to the user. For this reason, there are performed functional tests for the corresponding filtration devices, and also similarly for other kind of purification devices, for example, water purification devices including chemical cleaning steps as disclosed in international patent application W02008/067816 by Vestergaard SA. However, a global standard does not yet exist.

25

In connection with portable water purification devices, special attention is given to purification devices that are used in rural areas or emergency situations where clean water is scarce. The purification devices have to function reliably over months or even years, as these devices, often, are the only means available for guaranteed purified 30 water, and no frequent supply of such devices is available. Typically, the purification 2 DK 177203 B1 devices are transported long distances for delivery in such areas, and the devices are subsequently exposed to rough handling during long term usage.

People in emergency areas or other rural areas, as described above, should be guaran-5 teed reliable water purification means living up to high standards, as malfunctioning is fatal. For this reason, global testing methods are required.

DESCRIPTION / SUMMARY OF THE INVENTION

10 It is therefore the object of the invention to provide steps for a reliable test procedure for liquid purification devices, preferably, a global standard test procedure. The test procedure should also be useful for testing liquid filtration devices in other areas, for example, devices for medical usage in medical separation processes.

15 This purpose is achieved with a number of handling simulations of a liquid purification and/or filtration device as explained in the following.

The term filtration has to be understood as a mechanical separation process, where a membrane or a fibrous, adsorptive filtration material retains particulate matter. This 20 retaining of particulate matter may be used for purification of a liquid or for increasing the concentration in a liquid, the latter especially used for biological or medical purposes, for example in treatment of blood. The term purification may cover these filtration processes as well if the purpose is purification, however, it also covers non-filtrative liquid purification as it is known from chemical treatment of water with sub-25 sequent exposure to adsorptive granular activated carbon (GAC) in order to kill and remove microbes.

In a preferred embodiment, the liquid filtration and/or purification device is a portable water filtration device with a housing having a liquid inlet upstream of a microporous 30 filter and a clean water outlet downstream of the microporous filter. For example, the filter is a bundle of hollow microporous membranes. An example of such filtration devices has a tubular housing, for example made of polycarbonate or polypropylene, containing the microporous membrane. For example, the housing has a length of less 3 DK 177203 B1 than 50 cm, rather in the interval of 20 to 40 cm, and a cross section of the tubular housing of less than 6 cm, rather in the interval of 2 to 4 cm. An example of such a filtration device is commercially available under the name LifeStraw®.

5 In the following, a number of simulations are explained. These are simulations testing the stability of the device when exposed to A- Truck drive into rural areas B- Drop of a bulk box containing the device C- Weathering and aging of the device 10 D-Drop of a single device E- Impacts F-Static loads G- Long term use of moving parts of the device H-pressure stability 15

These procedures may be combined into sequences. Advantageous sequences are sequences with the steps A and B, A and B and C, A and B and D, A and B and E, A and B and C and E, A and B and D and E, A and B and C and D and E, where the sequence of step can be subject of permutation, for example, the sequence “A and B and 20 C” includes the sequences A+B+C, A+C+B, B+A+C, B+C+A, C+A+B, and C+B+A.

If a sequence of simulations is used, advantageously, although not strictly necessary, the device is inspected after each of the simulations. An alternative is inspection of the device after a selection of simulations in the sequence or just a single inspection after 25 the entire sequence of simulations.

One of the possible test methods implies creating overpressure of gas in the device and testing, whether the gas leaves the device. Gas is a good detection method, because gas finds its way through even very small cracks and can be easily verified by observa-30 tion of bubbles in a test where the device is kept under water or other liquid. Such tests are described below as test J.

4 DK 177203 B1

Another possible test method is a measurement of the log reduction of microbes. Such an evaluative test is described below as test K.

For example, the purification and/or filtration device may be of the kind having a liq-5 uid inlet and a liquid outlet and a liquid filter or a non-filtrative purification means or both included in the flow path of the liquid between the liquid inlet and the liquid outlet. In the following, the filtration and/or purification device will be denoted “device” for sake of simplicity.

10 If the device has a microporous filter, the device may, optionally, be equipped with a forward flush and/or backflush facility. For portable devices, which are predominantly envisaged here, the backflush facility advantageously includes a manually compressible balloon connected to the downstream clean water side of the filter. Exerting pressure on such balloon creates overpressure on the downstream side of the filter and 15 forces clean water backwards through the membrane of the filter in order to remove scale and clogging material from the influent side of the membrane.

Each of the following simulations or tests A though J is in its character independent from the other simulations or tests among A through J described herein. However, the 20 simulations or tests among A though J may advantageously be combined.

Simulation A - Truck transport simulation

The simulation has the purpose of simulating transport of boxes containing one or 25 more of the devices. The simulation contains vibrations that are believed to be transferred to the box when transported by a truck. For this reason, one or more transport boxes, for example two boxes, are filled with assembled and packed devices for the simulation. The box is then exposed to vibration.

30 Optionally, the device in the box is heated to a temperature TAi in the interval of 60°C to 100°C or cooled to a temperature Ta2 in the interval of -30°C to 10°C for the vibration simulation. In order to reach a temperature in this range, the box is heated to a temperature above ambient temperature. For the lower temperature range, it is envis 5 DK 177203 B1 aged that the device is cooled to below ambient temperature. For the heating and/or the cooling, a heating apparatus or a cooling apparatus can be used.

For example, the vibrations having an amplitude in the interval of 10 mm to 20 mm or 5 10 mm to 15mm, for example in the interval of 12 to 14 mm, possibly 13 mm

An optional frequency range for the simulation is 1 to 100 Hz or even 1 to 200 Hz. For example, the box is exposed to the entire range by continuously changing the frequency over that range. Alternatively, continuous sub-ranges of frequencies may be 10 selected for the simulations. As a further alternative, the entire range or one or more selected subranges may be selected and the box exposed to discrete frequency points in the range or selected sub-ranges. For example, the box may be exposed to a vibrational sequence of 1Hz, 2Hz, 3Hz, etc. up to 100 or 200 Hz.

15 In a further embodiment, the vibration is randomly changed within the vibration range of 1 to 200 Hz; or in one or more subranges within this interval of 1 to 200 Hz; or with discrete frequencies selected in this interval.

In one embodiment, the method for testing the device being a liquid filtration device 20 or a non-filtering liquid purification device comprises - heating the device to a temperature Tai in the interval of 60°C to 100°C or cooling the device to a temperature Ta2 in the interval of -30°C to 10°C, - performing a vibration test, wherein the vibration frequency is within the range of 1 to 200 Hz. Optionally, this test is performed with the device being packed in a trans- 25 port box, as this is typically the case when transporting such devices.

An optional time length ϊαι for the exposure to vibrations is at least 30 minutes or at least 1 hour, for example 30 minutes to 12 hours, or 1 to 5 hours or 1 to 4 hours or 2 to 4 hours or 3 hours.

30

An example of vibrational intensity is 0.2 to 0.8 G (rms, root mean square value), where G is the gravitation of 9.82m/s2, for example 0.4 to 0.7 G (rms) or 0.5 to 0.6 G (rms) or 0.52 G (rms).

6 DK 177203 B1

In a special embodiment, a random vibration test denoted “Simulation A3”, is performed according to the transport norm ASTM D-4169 for a truck drive simulation with assurance level Π for a time span of ϊα2 of in the interval of 30 minutes to 6 hours, 5 for example 1 to 5 hours or 2 to 4 hours or 3 hours. In a Simulation Al, tA2 is 3 hours and, optionally, the vibration has an intensity of 0.52 G (rms).

Alternatively or in subsequent addition, the simulation may imply a second simulation, Simulation A4, of a loose vibration simulation following the transport norm ASTM D-10 999 for a time span of ϊα4 of in the interval of 30 minutes to 6 hours for example 1 to 5 hours or 1 to 2 hours or 1 hour, at Frequency A in the interval of 3 to 6 Hz and an Amplitude Al in the interval of 10 to 40 mm. In Simulation A2, Frequency A is 4.5 Hz, Amplitude Al is 25 mm, and ϊα4 is one hour for a simulation according to the transport norm ASTM D-999.

15

In a further embodiment, Simulation A5, the simulation Al and simulation A2 are serially combined.

These vibration simulations can be performed at room temperature. A harder test for 20 the material, however, is obtained by performing the simulations under heated or cooled conditions, for example by first performing the simulation at heated conditions and then cooled conditions. Examples of heated conditions imply temperatures in the range of 60°C to 100°C, for example 70°C or 80°C. Examples of cooled conditions imply temperatures in the range -30°C to 10°C, for example at -20°C or 10°C. In case 25 of combination of heating and cooling, an example of a suitable temperature combination is -20°C and 80°C for a rough simulation and 10°C and 70°C for a standard simulation.

Especially, a test may imply the above simulation Al combined with A2 at a tempera-30 ture of -20 degrees and repeated by the same test at 80°C, or performed at 80°C first and at -20°C subsequently. Alternatively, the simulations Al is performed at these two temperatures followed by A2 performed at these two temperatures.

7 DK 177203 B1

An example of a simulation sequence for a box containing a device or rather a plurality of devices is performed in the following way: - conditioning at a first temperature TAi of 60°C to 100°C the box for a time span of 1-5 hours 5 - performing Simulation A3 for a time span 1-5 hours - re-conditioned at TAi of 60°C to 100°C for a time span of 1-5 hours - perform Simulation A4 for a time span of 0.5 - 2 hours - conditioned at a second temperature of -30°C to 10°C for a time span of 1-5 hours 10 - perform Simulation A3 for a time span of 1-5 hours - re- conditioning at Τλ2 -30°C to 10°C for a time span of 1-5 hours - perform Simulation A4 for a time span of 0.5 - 2 hours

The term “conditioning” implies that the temperature actually is attained by the de-15 vice, despite any insulating package inside the box.

An example of a Sequence A for a box containing a device or rather a plurality of devices is performed in the following way: - conditioning the box for 3 hours at a first temperature TAi 20 - performing Simulation A1 - re-conditioned at TAi for 3 hours, - perform Simulation A2 - conditioned at a second temperature TA2 for 3 hours - perform Simulation A1 25 - re- conditioned at for 3 hours - perform Simulation A2

For example, the temperatures are (TAi, 1^)=(80 °C, -20°C) or (TAi, 1^)= (70°C, 10°C).

30

Simulation B - Drop test bulk box 8 DK 177203 B1

This simulation B has the aim of simulating a drop of a box of packaged devices that can occur during transport.

In this Simulation B, a transport box with at least one device is dropped onto a hard 5 floor from a height of Hb , for example a height HB in the interval of 1 to 4 meter, for example 2 to 3 meter or 2.5 meter.

Optionally, this simulation is performed at elevated or lowered temperature. Examples of heated conditions imply temperatures in the rage of 60°C to 100°C, for example 10 50°C or 80°C. Examples of cooled conditions imply temperatures in the range -30°C

to 10°C, for example at 0°C or 10°C. In case of serial combination of heating and cooling, an example of temperature combinations is 0°C and 80°C for a rough simulation and 10°C and 50°C for a standard simulation.

15 The preferred simulation Sequence B is a first drop after conditioning of the box at TBi and once again after conditioning at TB2, where the temperatures are (Tbi,Tb2)=(80°C, 0°C) or (TBi,TB2)= (50°C, 10°C).

Alternatively, the temperatures are (TBi,TB2)=(0°C, 80°C) or (TBi,TB2)= (10°C, 50°C) 20

Simulation C - Weathering and aging

This simulation is used for provoking aging of the plastic under elevated temperature, 25 moisture, or UV light exposure, or a combination of these.

In this simulation, the device without transport box is exposed to a temperature of 40°C to 80°C for a period of 100 to 1000 hours, optionally combined with exposure to humidity, for example a humidity RH of 30% to 80%, for example 30% to 50% and 30 optionally with exposure to UV radiation.

9 DK 177203 B1

In Simulation Cl, the device is exposed to elevated temperature for a time tc and, optionally, with exposure to humidity. The latter can, optionally, be achieved by humidifying the device repeatedly during the simulation time tc. For example tc is 100 to 1000 hours or 200 to 800 hours or 400 to 600 hours, or 500 hours.

5

In Simulation C2, the device is exposed to UV light for a certain time tc , optionally, with exposure to humidity. The latter can be achieved by humidifying the device by water exposure repeatedly during the simulation time tc. Optionally, the repetition of the humidification has a frequency of 1 to 4 hours. An exampled for a UV light source 10 is a Xenon arc lamp certified for ISO 4892.

The Simulations Cl and C2 may, advantageously be combined, such that the device is exposed to UV light under elevated temperature conditions at a temperature Tc and exposed to humidification For example, Tc is in the interval of 40°C to 60°C; a good 15 value is 50°C.

An example of a simulation is a 500 hours exposure to UV light of the above stated type at a temperature of 50°C with regular or steady humidification.

20 For example, the simulation may be performed by exposure of the device to a temperature of 40°C to 60°C for 100 to 1000 or 200 to 800, optionally including exposure to UV light, for example according of the above described type. The sequence comprises 100 to 300 cycles. Each cycle contains exposure to 40°C to 60°C and a humidity RH of 10% to 40% or 40% to 60% followed by humidifying by water from a 25 shower. The RH levels are switched between 10% to 40% and 40% to 60% every 6 to 48 hours.

A further simulation Sequence C3 is exposure to 50°C for 500 hours, optionally including exposure to UV light, for example according of the above described type. The 30 sequence comprises 150 cycles of 120 minutes. Each cycle contains 102 minutes at 50°C and a humidity RH of 30% or 50% followed by + 18 minutes humidifying by water from a shower. The RH levels are switched between 30% and 50% every 24 hours.

10 DK 177203 B1

Simulation D - Drop test single product

This check simulates a drop that can occur in a normal using environment.

5

The device without any package is dropped from a height of 1 to 3 meter, optionally 1.8 m onto a hard floor. For example, the temperature is 20-30°C. For a rougher check, the temperature of the device is lowered to a temperature of -30°C to 10°C or raised to an elevated temperature of 40°C to 80°C for the drop onto a hard floor. For a 10 more soft check, the device is dropped on a cardboard covered floor.

In one embodiment, the simulation includes 10 drops at an elevated temperature of 40°C to 80°C, for example 40°C to 80°C, followed by 10 drops at a lowered temperature of -30°C to 10°C, all onto a hard floor from 1.8 meter.

15 A preferred simulation Sequence D1 includes 10 drops at 50°C followed by 10 drops at 10°C, all onto a hard floor from 1.8 meter. In another simulation, Sequence D2, the device is dropped at room temperature 5 times onto a cardboard covered floor from 1.8 meter.

20

Simulation E - Impact check

The impact check simulates a drop from a height He, for example He being 1 to 2.5 meter, for example 1.8 m, with the most vulnerable parts of the device hitting the floor 25 first.

The simulation uses the setup, where a steel ball with a weight of 500 to 1000 grams, for example 600 to 800 grams or 700 grams is attached to a cord of length HE of 1 to 3 meter, for example 1.5 and 2.5 meter or He being 1.8 meter. The ball with the cord is 30 fastened to a ceiling and held horizontal as a start position, after which it is released in order to accelerates on its way downward, where it hits the device, especially at vulnerable parts, for example flush valves or backflush balloon connectors.

11 DK 177203 B1

The check may be repeated several times. For example, it may be executed 2 to 8 times, or 3 or 5 times, optionally at different parts for each check or series of checks.

For example, the ball may hit the device consecutively 3 times as described, each time at a different vulnerable part or the same part under different angles.

5

In order to increase the effect of this check, the device may be cooled to a temperature Tei below room temperature or heated to an elevated temperature Te2- Alternatively, the device may be cooled to TEi in a first check or series of checks and then be exposed to a second check or series of checks at Te2· Non limiting examples of tempera-10 tures Tei are -10°C to 15°C or 0°C to 15°C, for example 8°C to 12°C or 10°C. Non limiting examples of TE2 are 40°C to 80°C, or 50°C.

In a simulation Sequence E, a steel ball with 700 grams on a cord of 1.8 m is hitting the device subsequently at three vulnerable parts while the device has been condi-15 tioned to 50°C followed by three corresponding hits at 10°C.

Simulation F - Static load

The static load check simulates a static loads applied to the product during normal use.

20

In one embodiment, a simulation is performed with static load of 10 - 40 kg, for example 15 to 30 kg, at a temperature of 20°C to 80°C, for example 40°C to 60°C.

A first specific type of simulation, Simulation FI, is performed with static load of 15 25 kg at a temperature of 40°C. A second, harder type of simulation, Simulation F2, uses a static load of 30 kg. An even more challenging simulation, Simulation F3, uses a static load of 30 kg after heating of the device to 50°C.

If the device is tubular, the static load is provided normal to the longitudinal axis of 30 the tube. In a practical embodiment, the device is placed on a smooth plane surface. Optionally, the static load is provided as a steel disc, for example having a diameter of 50 mm. The first contact is made before the force is applied, and the force is increased within 1 to 10 seconds until full load.

12 DK 177203 B1 A time for the static test is between 1 minute and 2 hours, for example between 5 and 10 minutes.

5

Simulation G - Endurance check of moving parts

This simulation is a check of the endurance of the moving parts of the device, for example turn valves, which are typically used on water purification devices.

10

In a first simulation, a valve is opened and closed a number of times as estimated to be approximately equal to the number of times that the valve is opened during the lifetime of the device, for example 10,000 to 100,000 times at a temperature of 0°C to 80°C.

15

For example the valve is opened and closed 25,000 to 75,000 times, for example 50,000 times. A suitable operation temperature for this simulation is 0°C to 80°C, for example 10°C to 50°C or 20°C to 30°C. If the device is a water filtration device with a clean water outlet valve, the simulation would be appropriate for such a valve. There-20 fore, for a water filtration or purification device with a clean water valve, in a simulation Sequence Gl, the valve is opened and closed 50,000 times at a temperature of 20°C to 30°C.

In a second simulation, a valve is opened and closed a number of times as estimated to 25 be equal to the number of times that the valve is opened during the lifetime of the device, for example 1,000 to 2,000 times or 1.100 or 1,300 times. A suitable operation temperature for this simulation is 0°C to 80°C, for example 10°C to 50°C or 20°C to 30°C. If the device is a water filtration device with a microporous membrane filter, for example with a hollow fiber membrane bundle, and configured for forward flushing 30 and/or backward flushing though a flush water outlet valve, the check for such a flush valve should be different from the clean water valve, as this flush valve, during normal operation, is not used as frequently as a clean water valve. For this reason, this simulation is appropriate for a flush valve. For a more realistic simulation, the device may be 13 DK 177203 B1 filled with turbid water for the flush water outlet valve simulation test. Accordingly, with such turbid water in the device at 20°C to 30°C, the flush valve is opened and closed 1300 times in a simulation Sequence G2 and 1100 times in a simulation Sequence G3.

5

If the device is a water filtration device with backflush capabilities, and a compressible balloon is provided for the backflush facility, an option for a check of the balloon is the following. In this simulation, the balloon is squeezed 1000 to 5000 times when containing liquid. In simulation Sequence G4, the balloon is squeezed with tap water 10 at 20°C to 30°C for 4,000 times, and in simulation Sequence G5, it is squeezed 3300 times according.

All Sequences G1-G5 include a visible inspection of the moving parts for damages.

15 Simulation H - Pressure stability.

This simulation is used for checking the reliability of the product when put under pressure. The device is filled with gas, for example air, and subjected to internal pressure of Ph for a time tH· Suitable values for Ph are 0.5 to 2 bar above atmospheric pressure, 20 for example 0.8 to 1.5 bar or 1 bar. Suitable values for tn are 5 to 60 seconds, for example 10 seconds.

A liquid pump may be used for creating the liquid pressure inside the device, while all taps are closed. If the device is a liquid filtration device with an internal filter, the 25 pressure should be applied to the upstream side of the filter and also to the downstream side of the filter. For example, the pressure may be provided to the upstream side first and then to the downstream side.

If the device is a tubular water filtration device, the pressure may be applied to a water 30 entrance connector in order to check the upstream side. It may then be connected to the water exit or, if present, to the connector of a back flush balloon. In a Simulation Sequence H, the device is connected with its water inlet to a water pump to create pressure of 1 bar inside the device for 10 seconds, after which the pressure is applied 14 DK 177203 B1 to the connector for the backflush balloon to create a pressure of 1 bar inside the device for 10 seconds.

Simulation J - Microbiological challenge 5

If the device is a water filtration device, or otherwise water purification device, it is advantageously checked for microbiological performance. For this reason, its capability for reduction of microbe concentration is checked by exposing the device to a liquid containing microbes, which should be removed to a sufficient degree. The degree 10 of microbe removal is typically measured in the reduction in terms of the logarithm of 10. Thus, a log 3 reduction of bacteria means that, after the filtering, the concentration of living bacteria is reduced to 0.1%.

In a Check Jl, one criterion for passing the test is a log reduction of parasites of at 15 least 3.

In a Check J2, one criterion for passing the test is a log reduction of bacteria of at least 6.

In a Check J3, one criterion for passing the test is a log reduction of virus of at least 4.

In a Check J4, the criteria Jl, J2, and J3 are combined.

20 K: Leaking check

For a water filtration device with a water inlet upstream of a microporous filter, a clean water outlet with clean water valve, a backflush balloon and a backflush water outlet, the following leaking checks may advantageously be used for checking the de-25 vice after one or more of the above simulations, for example after each simulation.

For example, the temperature for the leaking check is in the interval of 15°C to 25°C.

Check K1 is used for checking possible leaks in welds and at the backflush water tap.

30 The taps of the device are closed. The balloon has to be connected, and a compressor is connected to the water inlet exposing the device to pressurized gas. The device is kept under water, and it is checked for leaking of bubbles.

15 DK 177203 B1

Check K2 is used in a search for possible leaks in the clean water outlet. A compressor is connected to the backflush balloon connector and the clean water outlet valve is closed. The device is kept under water, and it is checked for leaking of bubbles. This check may also be used to check the tightness of a microporous membrane inside the 5 device.

Check K3 is used for checking the balloon. A compressor is connected to a clean water outlet with open outlet valve. The device is kept under water, and it is checked for leaking of bubbles.

10 A pressure value for the pressurised gas is in the interval of 0.3 to 4 bar above atmospheric pressure, for example in the interval of 0.3 to 1 bar above atmospheric pressure or 0.5 bar.

15 In Sequence K4, the three checks, Kl, K2, and K3 are combined as a serial sequence. Combination Check

In the following, a series of simulations are tabularised for a standard test and a worst-20 case-testing of a number of boxes, optionally 2 boxes, with sequential steps A-J. Optionally, each step apart from step J is followed by a check according to Sequence K4.

Worst-case simulation Standard simulation A Sequence A with Sequence A with (Tai, Ta2)=(80 °C, -20°C) (Tai, Ta2>= (70°C, 10°C) B Sequence B with HB=2.5 m Sequence B with HB=2.5 m (TB1,TB2)=(80oC,0°C) (TB1,TB2)= (50°C,10°C)

C Sequence C3 with environment tem- Sequence C3 with environment temperature: 50°C perature: 50°C

including UV exposure ISO 4892 D Sequence D1 with height 1.8m Sequence D2 with height 1.8m

E Sequence E no simulation E

16 DK 177203 B1 F Simulation F3 Simulation F1 G Sequence GI, G2, G4 Sequence GI, G3, G5

H Simulation H Simulation H

J Check J4 Check J4

It should be emphasized that the term “in the interval of’ for parameter intervals includes the endpoints of the interval.

5 SHORT DESCRIPTION OF THE DRAWINGS

The invention will generally be explained further with reference to the drawing, where FIG. 1 illustrates a water filtration device; FIG. 2 illustrates a water filtration device with greater detail of the valves; 10 FIG. 3 illustrates an impact simulation E for testing the mechanical stability of the device; in FIG. 3a, the ball hits the clean water valve laterally to the longitudinal axis of the tubular device, whereas in FIG. 3b, the ball hits the flush water valve parallel to the longitudinal axis of the tubular device; FIG. 4 illustrates a static load on the filtration device.

15

DETAILED DESCRIPTION / PREFERRED EMBODIMENT

FIG. 1 illustrates a portable water filtration device 1 for the proposed test. The filtration device is similar to the marketed water filtration device LifeStraw®. The filtration 20 device 1 comprises a housing 2 inside which a number of microporous capillaries 3 are contained. Water enters 4 through an inlet 5. The water flows through the capillaries 3 into an outlet chamber 6 in the lower end, from which it can be released through a flush water valve 7 at a flush outlet 8 in the case of forward flush. If the flush water valve 7 at the flush outlet 8 is closed, the pressure on the water drives the water 25 through the walls 10 of the capillaries 3 and into the interspaces 11 between the capillaries 3. From the interspaces 11, the water can be released for consumption through a clean water outlet 12 having a clean water outlet valve 13. In addition, the filtration device 1 has a compressible balloon 14 in which clean water is accumulated. As the balloon 14 is located lower than the clean water outlet 12, it is filled with clean water 17 DK 177203 B1 before water is released through the clean water outlet 12. When the clean water outlet 12 is closed by the clean water valve 13, and pressure is exerted on the balloon 14, pressure drives the water from the balloon through the capillary walls 10 and back into the inner volume 15 of the capillaries 3. This back flush presses microbes and other 5 particles out of the capillary pores and away from the inner surface 16 of the capillaries 3. A subsequent or simultaneous forward flush through flush outlet 7 removes the microbes and particles from the filtration device 1.

A different type of water filtration device, where a flat membrane instead of capillaries 10 is used is illustrated in International patent application W02008/110172 by Vester-gaard SA.

FIG. 2 illustrates a water filtration device in greater detail with respect to the clean water valve 13 at the upper end 17 and the flush valve 7 at the lower end 18. The con-15 nector 19 is used for attachment of a balloon under normal operation condition.

Although the simulations are described in connection with a water filtration device, the test methods are of a general nature may also be applied for medical filtration devices, for example those that are used for concentration or filtration of body fluids.

20 FIG. 3 illustrates the above mentioned Simulation E. A steel ball 20 with a weight of 500 to 1000 grams, for example 600 to 800 grams or 700 grams is attached to a cord 21 of length He, for example He being 1.8 m. The ball 20 with the cord 21 is fastened to a ceiling 22 and held horizontal as a start position, after which it is released in order 25 to accelerates on its way downward, where it hits the device 1, especially at vulnerable parts, for example flush valves 7 or backflush balloon connectors 19.

FIG. 4 illustrates the above mentioned static load Simulation F. The water filtration device 1 has a tubular housing 2, and the static load 23 is provided normal to the lon-30 gitudinal axis 24 of the tubular housing 2. In a practical embodiment, the device 1 is placed on a smooth plane surface 25 and the static load 23 is provided by a steel disc 26, for example having a diameter of 50 mm.

Claims

1. En fremgangsmåde til testning af en indretning, hvor indretningen er et filter til filtrering af væske eller en ikke-filtrerende rense-indretning, hvilken fremgangs- 5 måde omfatter - at indretningen opvarmes til en temperatur TAi over omgivelsernes temperatur eller afkøles til en temperatur TA2 under omgivelsernes temperatur, - at der uføres en vibration af indretningen, hvor vibrationsfrekvensen er i området fra 1 til 200 Hz. 10A method of testing a device, wherein the device is a liquid filtration filter or a non-filtering cleaning device, comprising: heating the device to a temperature TA 1 above ambient temperature or cooling to a temperature; TA2 below ambient temperature - a vibration of the device is carried out where the vibration frequency is in the range of 1 to 200 Hz. 10

2. En fremgangsmåde ifølge krav 1, hvor metoden omfatter opvarmning af indretningen til en temperatur TAi i intervallet 60°C til 100°C eller en køling af indretningen til TA2 i intervallet -30°C til 10°CA method according to claim 1, wherein the method comprises heating the device to a temperature TA1 in the range 60 ° C to 100 ° C or cooling the device to TA2 in the range -30 ° C to 10 ° C.

3. En fremgangsmåde ifølge krav 1 eller 2, hvor vibration har en intensitet på 0,2 til 0,8 G.A method according to claim 1 or 2, wherein vibration has an intensity of 0.2 to 0.8 G.

4. En fremgangsmåde ifølge krav 1, 2 eller 3, hvor vibration af indretningen udføres i mindst 1 time. 20A method according to claim 1, 2 or 3, wherein vibration of the device is carried out for at least 1 hour. 20

5. En fremgangsmåde ifølge krav 1 eller 3, hvor fremgangsmåden omfatter, at indretningen tilvejebringes i en transportkasse, - at transportkassen konditioneres i en tid tA1 til en første temperatur TAi; - at der udføres en tilfældig vibrationstest, hvor vibrationsfrekvensen ændres til-25 fældigt inden for et vibrationsområde fra 1 til 200 Hz i et tidsrum tA2; - at der re-konditioneres ved TAi i et tidsrum på tA3; - at der foretages en løs vibrationstest på 4,5 Hz med en amplitude Al i et interval på 10 til 40 mm i et tidsrum tA4; - at indretningen konditioneres ved en anden temperatur TA2 i et tidsrum på tA5; 30. at der udføres en tilfældig vibrationstest, hvor vibrationsfrekvensen ændres til fældigt inden for et vibrationsinterval fra 1 til 200 Hz for et tidsrum på tA6; - at der re-konditioneres ved TA2 i et tidsrum tA7; - at der foretages en løs vibrationstest på 4,5 Hz og en amplitude Ai i intervallet på 10 til 40 mm i et tidsrum på tA8; 35 hvor tAi, tA2, tA3, tA4/ tA5, tA6, tA7; tA8; hver er i intervallet 30 minutter til 6 timer, og hvorTAi er i intervallet 60°C til 100°C, og TA2 er i intervallet -30°C til 10°C DK 177203 B1 2A method according to claim 1 or 3, wherein the method comprises providing the device in a transport box, - conditioning the transport box for a time tA1 to a first temperature TA1; - a random vibration test is performed wherein the vibration frequency is changed randomly within a vibration range from 1 to 200 Hz for a period tA2; - reconditioning at TA1 for a period of tA3; - a loose vibration test of 4.5 Hz is performed with an amplitude Al in a range of 10 to 40 mm for a period tA4; - conditioning the device at a different temperature TA2 for a period of tA5; 30. performing a random vibration test wherein the vibration frequency changes to fall within a vibration range from 1 to 200 Hz for a period of tA6; - reconditioning at TA2 for a period tA7; - a loose vibration test of 4.5 Hz and an amplitude Ai in the range of 10 to 40 mm for a period of tA8; Wherein tAi, tA2, tA3, tA4 / tA5, tA6, tA7; TA8; each is in the range of 30 minutes to 6 hours and wherein TA1 is in the range of 60 ° C to 100 ° C and TA2 is in the range -30 ° C to 10 ° C.

6. En metode ifølge krav 5, hvor (TAi, TA2) = (80 C°, -20°C) eller (TAi, TA2) = (70°C, 10°C).A method according to claim 5, wherein (TA 1, TA 2) = (80 ° C, -20 ° C) or (TA 1, TA 2) = (70 ° C, 10 ° C).

7. En fremgangsmåde ifølge krav 5 eller 6, hvor tAi,tA2;tA3; tA5j tA5og tA7 hver er 3 timer, og tA4 og tA8 hver 1 time.A method according to claim 5 or 6, wherein tAi, tA2; tA3; tA5j tA5 and tA7 each are 3 hours, and tA4 and tA8 every 1 hour.

8. En fremgangsmåde ifølge krav 5, 6 eller 7, hvor amplituden Ai er 25 mm.A method according to claim 5, 6 or 7, wherein the amplitude A 1 is 25 mm.

9. En fremgangsmåde ifølge et hvilket som helst af kravene 5-8, hvor den vilkårli ge vibrationstest udføres i henhold til transport normen ASTM D-4169 til en kørselssimulering foren lastbil med sikkerhedsniveau II.A method according to any one of claims 5-8, wherein the random vibration test is performed according to the transport standard ASTM D-4169 for a driving simulation for a truck with safety level II.

10. En fremgangsmåde ifølge et hvilket som helst af kravene 5-9, hvor den løse 15 vibrationstest udføres ifølge transport normen ASTM D-999 ved 4,5 Hz og med en amplitude Ai på 25 mm.A method according to any one of claims 5-9, wherein the loose vibration test is performed according to the transport standard ASTM D-999 at 4.5 Hz and with an amplitude Ai of 25 mm.

11. En fremgangsmåde ifølge et hvilket som helst af de foregående krav, omfattende at lade en transportkasse, der indeholder indretningen, falde på gulvet fra 20 en højde på 2 til 3 meter.A method according to any one of the preceding claims, comprising dropping a transport box containing the device on the floor from a height of 2 to 3 meters.

12. En fremgangsmåde ifølge krav 11, hvor transportkassen lades falde medens indretningen har en forhøjet temperatur i området 60°C til 100°C og efterfølgende når indretningen har en lavere temperatur i området -30°C til 10°C 25A method according to claim 11, wherein the transport box is dropped while the device has an elevated temperature in the range 60 ° C to 100 ° C and subsequently when the device has a lower temperature in the range -30 ° C to 10 ° C.

13. En fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor fremgangsmåden omfatter opbevaring af indretningen ved en temperatur på 40 til 60°C i 200 til 800 timer med en gentaget befugtning med vand hver 1 til 4 timer.A method according to any one of the preceding claims, wherein the method comprises storing the device at a temperature of 40 to 60 ° C for 200 to 800 hours with a repeated wetting of water every 1 to 4 hours.

14. En fremgangsmåde ifølge krav 13, hvor indretningen udsættes for en tempe ratur på 40°C til 60°C i 100 til 1000 timer, idet indretningen udsættes for 100 til 300 cykler, hvor indretningen udsættes for 40°C til 60°C ved en fugtighed RH på 10% til 40% eller 40% til 60% efterfulgt af befugtning med vand fra en bruser, hvori RH niveauer skiftes mellem 10% til 40% og 40% til 60% hver 6 til 48 timer. 35A method according to claim 13, wherein the device is subjected to a temperature of 40 ° C to 60 ° C for 100 to 1000 hours, the device subjected to 100 to 300 cycles, the device subjected to 40 ° C to 60 ° C at a humidity RH of 10% to 40% or 40% to 60%, followed by wetting with water from a shower, wherein RH levels change between 10% to 40% and 40% to 60% every 6 to 48 hours. 35

15. En fremgangsmåde ifølge krav 13, hvor indretningen opbevares ved en temperatur på 50°C i 500 timer, idet indretningen udsættes for 150 simuleringcyklusser af 120 minutter under disse 500 timer, idet hver cyklus indebærer 102 minutters opbevaring ved 50°C og en luftfugtighed RH på 30% eller 50%, efter DK 177203 B1 3 fulgt af 18 minutters befugtning med vand fra en bruser, hvor RH niveauerne skifter mellem 30% og 50% hver 24 timer.A method according to claim 13, wherein the device is stored at a temperature of 50 ° C for 500 hours, the device subjected to 150 simulation cycles of 120 minutes during these 500 hours, each cycle involving 102 minutes of storage at 50 ° C and a humidity. RH of 30% or 50%, after DK 177203 B1 3 followed by 18 minutes of wetting with water from a shower, where RH levels change between 30% and 50% every 24 hours.

16. En fremgangsmåde ifølge krav 14 eller 15, hvor indretningen udsættes for UV-5 lys under opbevaringen.A method according to claim 14 or 15, wherein the device is exposed to UV-5 light during storage.

17. En fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor fremgangsmåden omfatter at tabe indretningen på et gulv fra en højde i intervallet 1 til 3 meter. 10A method according to any one of the preceding claims, wherein the method comprises dropping the device on a floor from a height in the range of 1 to 3 meters. 10

18. En fremgangsmåde ifølge krav 17, hvor højden er 1,8 meter, og fremgangsmåden indebærer at lade indretningen falde 10 gange ved 40°C til 60°C efterfulgt af 10 fald ved -10°C til 15°C. 15A method according to claim 17, wherein the height is 1.8 meters and the method involves dropping the device 10 times at 40 ° C to 60 ° C followed by 10 drops at -10 ° C to 15 ° C. 15

19. En fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor der tilvejebringes en stålkugle fastgjort til en snor med en længde i intervallet fra 1 til 2,5 meter, hvor stålkuglen accelereres ved hjælp af tyngdekraften langs en kvart cirkel fra en vandret streng-orientering til en lodret streng-orientering, og indret- 20 ningen rammes af kuglen, når strengen er i den lodrette streng-orientering.A method according to any one of the preceding claims, wherein a steel ball is provided attached to a string with a length in the range of 1 to 2.5 meters, the steel ball being accelerated by gravity along a quarter circle from a horizontal string orientation to a vertical string orientation, and the device is hit by the ball when the string is in the vertical string orientation.

20. En fremgangsmåde ifølge krav 19, hvor strengen har en længde på 1,8 meter, og fremgangsmåden omfatter at ramme indretningen tre gange på forskellige dele, mens indretningen er konditioneret ved en temperatur på 40°C til 60°C. 25A method according to claim 19, wherein the string has a length of 1.8 meters and the method comprises hitting the device three times on different parts while the device is conditioned at a temperature of 40 ° C to 60 ° C. 25

21. En fremgangsmåde ifølge krav 19 eller 20, hvor fremgangsmåden omfatter at ramme indretningen tre gange på forskellige dele, når indretningen er konditioneret ved en temperatur på -10°C til 15°C.A method according to claim 19 or 20, wherein the method comprises hitting the device three times on different parts when the device is conditioned at a temperature of -10 ° C to 15 ° C.

22. En fremgangsmåde ifølge krav 11, hvor indretningen opbevares ved en tem peratur på 40 til 60°C i 200 til 800 timer med en gentaget befugtning med vand hver 1 til 4 time, og hvor en stålkugle tilvejebringes fastgjort til en snor med en længde på 1,8 meter, og stålkuglen accelereres ved hjælp af tyngdekraften langs en kvart cirkel fra en vandret streng-orientering til en lodret streng orientering og 35 rammer indretningen, når strengen er i den lodrette orientering, hvor indretningen rammes tre gange på forskellige dele, mens indretningen er konditioneret ved en temperatur på 40°C til 60°C, og indretningen rammes tre gange på forskellige dele, når indretningen er konditioneret ved en temperatur på -10°C til 15°C. DK 177203 B1 4A method according to claim 11, wherein the device is stored at a temperature of 40 to 60 ° C for 200 to 800 hours with a repeated wetting of water every 1 to 4 hours and wherein a steel ball is provided attached to a string of length. of 1.8 meters and the steel ball is accelerated by gravity along a quarter circle from a horizontal strand orientation to a vertical strand orientation and strikes the device when the string is in the vertical orientation, where the device is hit three times on different parts, while the device is conditioned at a temperature of 40 ° C to 60 ° C and the device is hit three times on different parts when the device is conditioned at a temperature of -10 ° C to 15 ° C. DK 177203 B1 4

23. En fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor indretningen udsættes for en belastning på 15 til 30 kg ved forhøjet temperatur på 40°C til 60°C, hvor belastningen forøges gradvist i løbet af 1 til 10 sekunder, 5 indtil fuld belastning.A method according to any one of the preceding claims, wherein the device is subjected to a load of 15 to 30 kg at elevated temperature of 40 ° C to 60 ° C, wherein the load increases gradually over 1 to 10 seconds. until full load.

24. En fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor indretningen har en rørformet polymerhus, hvor polymerhuset har en længde på mindre end 50 cm og et tværsnit på mindre end 6 cm. 10A method according to any one of the preceding claims, wherein the device has a tubular polymer housing, wherein the polymer housing has a length of less than 50 cm and a cross section of less than 6 cm. 10

25. En fremgangsmåde ifølge krav 24, hvor indretningen har et væskeindløb og et væskeudløb og et væskefilter eller et ikke-filtrerende rensemiddel eller begge indeholdt i strømningsvejen for væsken mellem væskeindløb og væskeudløb, hvori væskeudløbet omfatter en ventil. 15A method according to claim 24, wherein the device has a liquid inlet and a liquid outlet and a liquid filter or a non-filtering cleaning agent or both contained in the flow path of the liquid between liquid inlet and liquid outlet, wherein the liquid outlet comprises a valve. 15

26. En fremgangsmåde ifølge krav 25, hvor ventilen betjenes 10.000 til 100.000 gange.A method according to claim 25, wherein the valve is operated 10,000 to 100,000 times.

27. En fremgangsmåde ifølge krav 24 eller 25, hvor indretningen har en væske-20 filtermembran og et skylnings-væskeudløb for forlæns skylning med væske fra væskeindløbet til skylnings-væskeudløbet langs en indløbs-overflade af membranen, hvor skylnings-væskeudløbet har et skylleventil.A method according to claim 24 or 25, wherein the device has a liquid-filter membrane and a flushing liquid outlet for forward flushing with liquid from the liquid inlet to the rinsing-liquid outlet along an inlet surface of the membrane, where the rinsing-liquid outlet has a flushing valve.

28. En fremgangsmåde ifølge krav 27, hvor skylleventilen betjenes 1000 til 2000 25 gange.A method according to claim 27, wherein the flushing valve is operated 1000 to 2000 25 times.

29. En fremgangsmåde ifølge krav 27 eller 28, hvor indretningen har en manuel betjent ballon nedstrøms i forhold til membran-filteret for baglæns skylning af filteret. 30A method according to claim 27 or 28, wherein the device has a manually operated balloon downstream of the membrane filter for backward flushing of the filter. 30

30. En fremgangsmåde ifølge krav 29, hvor fremgangsmåden indebærer at klemme ballonen 1000 til 5000 gange ved en temperatur på 20°C til 30°C, medens ballonen indeholder væske.A method according to claim 29, wherein the method involves squeezing the balloon 1000 to 5000 times at a temperature of 20 ° C to 30 ° C while the balloon contains liquid.

31. En fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor fremgangsmåden omfatter indvendig tryksætning af indretningen med væske ved et tryk i intervallet fra 0,5 til 1,5 bar i 5 til 60 sekunder.A method according to any one of the preceding claims, wherein the method comprises internal pressure setting of the device with liquid at a pressure in the range of 0.5 to 1.5 bar for 5 to 60 seconds.

32. En fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor DK 177203 B1 5 fremgangsmåden omfatter indvendig tryksætning af indretningen ved et tryk på 0,3 og 1 bar over atmosfærisk tryk og anbringelse af indretningen i væske under tryk, samt kontrol for lækage ved at observere, om gas bobler inde fra enheden gennem væsken. 5A method according to any one of the preceding claims, wherein the method comprises internal pressure setting of the device at a pressure of 0.3 and 1 bar above atmospheric pressure and placing the device in liquid under pressure, as well as checking for leakage by observing whether gas is bubbling from inside the unit through the liquid. 5

33. En fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor fremgangsmåden omfatter at kontrollere egenskaberne for reduktion af mikrober, hvor egenskaberne omfatter en log-reduktion af parasitter på mindst 3, en logreduktion af bakterier på mindst 6, og en log-reduktion af virus med mindst 4.A method according to any one of the preceding claims, wherein the method comprises controlling the microbial reduction properties, the characteristics comprising a log reduction of parasites of at least 3, a log reduction of bacteria of at least 6, and a log reduction. reduction of virus by at least 4.