Bioen 215 AA 8:30- 9:20 am Clay-based Water Purification Kit 3/17/2011

Charles Dewey Hani Mahmoud Derek Britain Soly Malai Anupama Ramakrishnan

Team members contributions: Hani: problem statement, market analysis, abstract (focus on background information) Soly: Prior art, conclusions, cover page (focus on prior art) Derek: Design specifications, design description (focus on product) Anupama: Ethical considerations, regulatory issues, future work (focus on future impact) Charles: solution generation (focus on product)

Abstract:

There are a large number of diseases that are transmittable and generated through

unsanitary and stagnant water sources (i.e Cholera, E. coli, Dysentery, and Malaria). Every year, millions of individuals die from these diseases due to lack of filtration devices and education about water-based diseases. The majority of such deaths occur in rural Sub-Saharan Africa, where countless humanitarian efforts have tried and failed to successfully provide improved water sources due to the poverty and remoteness of the rural villages. This project attempted to alleviate water-based disease and illness in such areas through the implementation of specially designed kits, which include picture-based educational information regarding the dangers of unsafe water and instructions for building a clay filter device, as well as a sample of wood flour to be used in constructing the filtration system. After research on the subject, such a kit was determined to be highly effective for its impoverished, uneducated end-users due to the selfsustainable, simple, low-cost nature of the solution. If successfully distributed among rural villages, this kit has the potential to save thousands of lives from water-based diseases. Problem Description: In the past few

decades, improving access to clean drinking water has been the central focus of countless humanitarian efforts. This is due in part to the sheer number of diseases and illnesses that are caused by sub-par water quality. Diarrheal diseases such as Cholera are most prevalent and directly linked to the consumption of unsanitary water, but other afflictions such as Malaria
Figure 1

and malnutrition are also rampant within countries that lack clean water sources. (Fig. 1) Approximately 3.6 million deaths are caused each year by the aforementioned diseases. [1] Furthermore, more than 1 billion individuals do not have access to a recently improved water source. [2] This number reflects the entire global population; however, the majority of the individuals mentioned above tend to reside in similar rural regions. While humanitarian projects have improved water quality and access in most of the world through advanced filtration technology, one major region has hardly seen any improvement rural Sub-Saharan Africa and Oceania. Figures 2 and 3 illustrate the comparison between these regions and the rest of the world in terms of access to improved drinking water. [3]

Figure 2

Figure 3

Despite the extensive research and technology developed to improve water quality, 50% of projects fail and less than 1% are monitored long-term. [1] This fact can be attributed to the poverty and remoteness of the rural villages in the regions depicted above. Thus, a cheap, selfsufficient solution is likely the only way that villagers will be able to gain access to sanitary drinking water and thereby successfully overcome water-based diseases, which comprise of onetenth of the global disease burden. [1] All the facts, research, and tools exist, so the only challenge is to implement a solution that will provide its impoverished users with access to clean water permanently. Market Analysis: This project focuses on a group of end users that is composed of very

similar individuals from the same regionfamilies of rural villagers in Sub-Saharan Africa. Ideally these end users would be the customers as well, but this is nearly impossible due to their poverty and distance from urban civilization (i.e. paved roads). Also, ideally, the government could distribute our kits. However, conditions in Sub-Saharan Africa are often far from ideal, and governments do not always cooperate as planned. Thus, the initial customers are shop owners, especially potters, in semi-urban towns that rural villagers visit regularly to buy necessities. Because the kit focuses on education and a self-sustainable, do-it-yourself solution, it is not necessary for every family in a village to own one. The kit is intended not to require anyone to be present to provide usage or building instructions. Thus, all that is needed is for the end users to be aware of the kits existence. Hopefully this necessity will be fulfilled by the shop owners, who will want to advertise the product, because the shop owners will buy it for such a low price that they will be able to make profit. Due to the lack of accessibility to clean water and affordable solutions in the targeted region, this product is in high demand. It provides a source of filtered drinking water that over 1

billion people lack, and while it does not revolutionize the way medicine will be done, it definitely brings medical solutions to those who could never afford them in the past. [2] As mentioned beforehand, the entire field of water sanitation is extremely well researched and many companies and groups exist to find and implement solutions. The group most closely related to our specific field is Potters for Peace, a U.S. based non-profit that educates people about low-cost filters similar to those proposed in our kit. [4] While this group has been relatively successful, they are not a major competitor because they focus on Central America. The market for a product like our kits is large due to the continuing need for access to improved water all across rural Sub-Saharan Africa. Although the market has shrunk in urban areas (see Fig. 2), it remains large in rural areas due to their remoteness and extreme poverty. Efforts to improve the water situation in these areas have failed in part because 2/3 of those in need of an improved water source live off of less than $1/day. [1] Thus, these individuals cannot afford to pay more than a few pennies for a solution. They do not need technology; they need something affordable. Luckily, our kit only costs a few pennies. That fact and the fact that our kit does not need to be distributed by an organization gives us a competitive advantage and a hope for a permanent solution. Prior Art: Many existing solutions have been developed in the past in order to improve

water purification techniques as an attempt to improve the worlds drinking water quality. These techniques include methods such as solar water disinfection, slow sand filtration, and activated charcoal filtration. Solar water disinfection (SODIS) is a purifying method that exposes contaminated water to the sun for about 6 hours in clear PET bottle. Despite its effectiveness in killing

bacteria, parasites and other living microorganisms, this method has many limitations. These include its inability to filter out particulates, its long processing time, and its restricted temperature(the sun light must be above 50 degrees Celsius). [5] In addition, to purifying water in large scale, this method requires the use of many PET bottles which are not biodegradable thus can contribute to waste and recycling problems. Other than purifying water by UV light, many other filtration methods have also been explored. Activated charcoal filtration is a filtering method that traps carbon-based substances to the charcoal surfaces while allowing water to go through its pores. These tiny pores are opened between carbon atoms by treating charcoal with oxygen. This method is selective in filtering carbon-based substances only thus unable to filter out other harmful chemicals and ions. It is also unable to be reused once the binding sites on its surfaces are used up. [6] Since it requires oxygen treatment, this technique is unable to be reproduced locally, making it less accessible to many poor developing countries. Slow sand filtration method is a similar filtering technique as above as it traps particulates while allowing water to pass through bed of porous sands. This method is incapable of removing dissolved inorganic substances. Furthermore, the required sand must be industrially manufactured. Used sands also need to be disposed, which presents another challenge in developing countries due to the lack of skilled waste operators. [7] Despite the amount of solutions that have been proposed, many techniques still have drawbacks that make clean drinking water tough to access in poorer demographics. Overall, the limitations are due mainly to the low filtered/purified water quality, its slow processing time, and the inaccessibility to those techniques as they are unable to be reproduced locally. In order to overcome those limitations, our group turned our attention to a wood-fired clay filtering

technique. This technique can remove more than 95% of particulates from the water, requires simple resources such as clay and wood flour, and can easily be made locally. A study in Leifong, China has shown that implementation of a clay pot filter has significantly improved the lives of the people in that region, further proving that it is a good solution that we should implement. [8] Design Specifications Need #1: Effectively clean particulates and eliminate water-borne pathogens. Need #2: Implementable in rural and low-resource settings. Need #3: Easily transportable to areas with little or no infrastructure (paved roads, trains, electricity). Need #4: Low cost and easily accessible to low income individuals. Need #5: The ability to provide clean water over long periods of time. Design Constraints With our design we wanted to provide clean water to extremely poor and rural regions of sub-Saharan Africa and Oceania. The most important aspect of our product was to provide clean water. This meant eliminating heavy metals and water-borne pathogens. While 100% purification would be optimal, we felt that 95% and above would be acceptable, as many diseases require a large dose of bacteria for infection to take place. For example, between 105 and 108 cholera bacteria must be ingested for infection to occur. [9] Stemming from need #3, our product needed to be compact and lightweight so that it could be brought to isolated villages over long distances of rugged terrain. Simplicity was desired because human beings are more likely to use a product that is easy to use (Need #2). A simple design is easily maintained and repaired (Need #5). The device needed to be constructed from materials accessible to the users (Needs

#4,5). Constructing the device of common materials would make the overall cost much lower than if specialized materials were needed. This would also make repairs feasible and expedient as there would be no waiting on a specialty material or part. Design Criteria A few other factors we considered were the rate of filtration and the volume of water that could be filtered at one time. While these traits are desirable, they are not vital to accomplishing our goal. Need # Design Constraints Unit of Measure 1 2 3 4 5 Cleans Water Simplicity Lightweight Cheap Durability Repairable Acceptable Value Ideal Value 100 NA 1 0.1 5 NA

% Threat eliminated 95-100 NA Kg Dollars (USA) Time (y) NA NA 1-6 0.1-1 1-5 NA

Generation of Design Specifications We chose these designs specifications by first looking at our problem and identifying key components that needed to be addressed. We saw that there were two main aspects to our problem, the first being how to purify contaminated water, and the second being how to distribute and implement a water purification system in rural settings. We researched the infrastructure of our target areas in order to identify potential problems we would have to overcome. We also researched the materials available in those areas to help guide the purification system we would choose.

Solution Generation and Selection:

As a team, we decided that our purpose was to aid

remote regions find a renewable source of potable water. Through brain-storming we decided that we were most interested in forming a package that would allow for the more remote regions to provide a means for the indigenous population to gain access to potable wateras non-potable water is a serious problem in remote areas of the developing world. The rural areas are of such importance because eight out of ten individuals that do not have access to clean water are from rural regions. [3] Through internet research we were able to discover multiple sources that discuss the implementation of filtration devices in rural areas, and many different organizations with the purpose of bringing the resource of clean water to these suffering people. Potable water in rural areas is integral to world health as unclean water leads to a large percentage of health issues; for example there are two million diarrheal deaths related to unsafe water, sanitation, and hygiene each yearthe vast majority are children under five. [2] Originally the team pooled ideas of different types of water purification and filtration, concentrating on simple and effective devices, in order that untrained individuals would be able to effectively and efficiently employ the device or tools included in the kit. To this end, the following devices were primarily selected for their ease of use, filtration and purification capabilities, price, reusability, and durability: PET Bottles(SODIS), Slow Sand Filters, and Charcoal Filtration systems. After these devices were selected, further research was performed in order to determine which would best fulfill our desired criteria. We found that while the PET bottles would kill the pathogens in the water, they would not remove particulates such as heavy metals, harsh chemicals, or even the killed vectors and pathogens. This shortcoming steered us towards

slow sand filters and charcoal filters, which seemed to have more simplistic designs that would allow for the rural communities to manufacture the devices themselves. Manufacturing the device themselves would not only provide them with a method for potable water production, but it would also create a sense of pride in the community. This pride would be invested in the device that they had created, which would ensure that it was more respected and valued than if the device was simply handed to the community. After further online research into the production of bio-sand and charcoal filters it became evident that they would not be an ideal choice for a filter in remote areas. It is not an ideal choice because the sand that is required for slow/bio sand filters- as a primary component of the filtration processmust be from a sterile water environment, or from a quarry above the water level, which severely limits the availability of the sand. The charcoal that is used in the filters must be remotely manufactured, which would limit the ability of the indigenous community to replicate the filter. This rarity of the sand and charcoal makes the slow sand filter and charcoal filters poor choices, because it would be difficult to maintain, reproduce, or inexpensively produce such filters. As all of our previously researched designs had been rendered inefficient, a new device for the kit was required. Thus further research was preformed, which presented our final device: the organic particulate clay filter. The clay filter is essentially a straining filtration device that is mixed with coffee grounds or fine wood flour (wood ground into particles of rough and differing sizes) and then molded into a containing shape. Next, the clay is fired, causing the wood particles to burn off, thereby leaving minuscule pores in the clay and allowing water to filter through. The firing process can be accomplished in a fire pit system that does not rely on complicated kiln equipment, making it a feasible option for

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filtration. The clay would also be readily available, because during the firing process any organic pathogen or vector would be incinerated, thereby making the clay sanitary. Design Criterion Weight PET Bottle Purification System 5 Slow Sand/Bio Sand Filter 4 Charcoal Filtration system 4 WoodFired Clay Filter 4

Eliminates Pathogens/ Viruses Removes Particulates Renewable (locally) /Reusable Inexpensive Durable Low Maintenance Speed Weighted Totals

5 4

0 2

5 0

4 3

5 5

4 3 2 1 Poss. 120

4 4 4 4 73

4 4 3 3 82

4 4 1 3 65

4 3 3 3 99

We then created a Pugh chart that allowed us to quantify the effectiveness of each device type. We weighted our Pugh chart so that the device would be compatible with a rural setting, thus the inexpensive and renewable/reusable aspects of the criteria. Most important, however, is that the device is effective at its purpose--purifying waterhence we weighted the ability to eliminate pathogens/vectors and remove particulates the highest. While it is important for the device to be durable, it is less important than if it is re-usable. If the device breaks under a medium amount of stress, but is easily fixable or remarkable, then durability is a much less

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integral part. When the scores were totaled, the clay filter emerged as a clear leader, which directly compliments the design specifications specified in our previous research. Design Description: Our design is

centered on incorporating Tony Flynns clay pot filter into a cost effective and easily distributed water purification kit. [10] The kit will consist of two re-sealable PET jars, one with radius 6.5cm and height 20cm, the other with radius 5cm and height 18.5cm. The two PET jars will serve as outer and inner molds for forming the filter. This will ensure that the clay pot walls are of optimal filtration thickness. When not forming clay pot filters, the two PET bottles can be used to store water and for the SODIS method. The procedure for making the clay pot filter is explained on laminated, picture-based instructions included in the kit. The instructions have information about the causes and spread of waterborne diseases on the reverse. This information would also be heavily picture-based and stress basic sanitary practices, such as drinking clean water, proper disposal of waste, and sources of disease. Pictures would allow the largely illiterate population to understand. The kit also includes enough organic material to make one clay pot filter to serve as an example for the types of materials that can be used. A clay pot filter is made using a mixture of clay and a fine organic matter (coffee grounds, tea leaves, wood flour). Manure is also required to fire the clay. These materials can be

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located on sight, making the manufacture of the filter cheap and accessible to rural villages. The principal behind the clay pot filter is that firing the pot causes the organic material to combust, leaving tiny pores behind in the pot. Firing also causes the clay to contract, shrinking the pores and increasing the effectiveness of the filter. The primary potential problem we face is quality control. While putting the manufacturing process in the hands of users makes the system more distributable and allows for easy replacement of broken filters, it gives us little control over the final product. This could open the door for errors in the manufacturing process that could result in inadequate filtration. To minimize this issue we must implement extensive testing of our instructions in multiple ethnic and cultural groups. There is potential for a similar problem with having the user acquire the necessary materials on site. The user may not have suitable organic materials or access to quality clay. We hope that providing examples of organic materials and implementing our device in areas where quality clay is available will reduce this issue. Following is an example of the instructional pictures that will be included in the kit:

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Step 1: Dry Clay in Sun

Step 4: Add water, mix into moldable clay

Step 2: Grind Clay into fine Powder

Step 5: Insert clay into large jar. Press small jar into center of clay. The two jar tops should be flush.

Step 3: Mix equal parts clay and organic material

Step 6: Remove inner and out jars from clay pot

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Step 7: Allow clay to harden in sun

Step 10: Cover the clay with more manure as needed

Step 8: Build fire of manure, sticks and leaves around clay

Step 11: After one hour, remove clay from fire. Caution Hot!

Step 9: Cover completely with manure. Fire the clay for one hour

Step 12: Pour water into cup and catch the filtered water in kit jar or other container

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Ethical and societal considerations:

Our project is comprised of a very simple design

involving the use of clay and organic material. These materials are readily available and can be easily afforded by the members of the developing communities. It does not involve controversial issues such as stem cell use and organ transplantation. However, there are some potential problems could arise while implementing this filtration device in developing communities. Since there are several filtration models that have already been experimented with in these low-resource communities, it is possible that the community members would want to choose one model over the other. The benefits of the clay-based filtration device may not be made evident enough to the members of the community due to inadequate communication by volunteers or distributors. The community members might want to make changes in the design model of the filter to further suit their convenience. These changes, if not made correctly, could cause a substantial disturbance to the efficient functioning of the device. Another social consideration would be to consider compensating community volunteers for their work. It is usually understood that community volunteers would not have any monetary gains through the filter installation project. However, social and financial constraints could lead volunteers to demand for payment, which may not be covered by grant money. [11] These complications are likely, but can be avoided with good communication and coordination from supporting organizations. Education, health training, and follow-up are critical for successful implementation of the filtration device in developing communities, and this can be achieved with cooperation from global health promoting organizations. Regulatory issues: In order to launch our device to market, we will have to get it approved

by the FDA. For this, we will first need to find out which class our device falls under and determine the correct FDA code and regulation number. Since it is a life-sustaining device

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which offers clean drinking water to people, it would have to be classified as a class III device. While preparing the documents for submission, we will have to find similar devices that have previously received an FDA approval and determine whether they can be suitably used in the submission (Ex: SODIS). The next step would be to review our testing requirements and applicable FDA guidance documents and standards. In addition to this, we will be required to submit all documents, reports, diagrams and clinical data for 510(k) preparation to begin. Next, we will need to prepare a technical comparison of our device to other predicate devices with FDA 510(k) clearance. Once all of the required data has been collected, we will need to prepare all the 21 sections of the FDA application and submit the 510(k) to FDA along with the submission fee. Upon clearance of the device, we will have to prepare for the establishment registration process with the FDA. [12,13] To further test the efficiency of our device, we would organize a randomized trial in a fixed number of rural communities in a country to evaluate the ability of our clay-based filter to reduce water-borne. This could be done by randomly assigning individuals to receive an interventionconsumption of purified water from the clay-based filter. Another set of individuals would act as controls. The findings from this research can be evaluated to test for the efficiency of the filter. [14] Conclusions: Through the course of this project, our group has acquired many skills relating

to the engineering design process that are important for our future practice as bioengineers. First, we worked together and gathered various literature in order to identify a common issue that we considered a major global health problem. After we came to an agreement of focusing on the clean water issue, we did further research to explore and discover specific needs and areas that we wanted to address. We then found out that despite the many solutions that have already been proposed to improve water quality, those techniques are mainly unavailable to the

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people who need them most. After weighing the advantages and constraints of different purifying techniques, we started to design our Water Purification kit that would overcome the main inaccessibility problem. Since we are unable actually build this kit and put it in practice, we can only guess the impacts of our specifically designed kit as follow. The Water Purification kit that we developed is an inexpensive, small, easy to follow instructional package that allows it to be widely distributed to many remote regions worldwide. Due to this high portability, it allows the already available wood-fired clay filtering technique to be more accessible to the people. This technique, along with the picture-based information of the danger of unsafe water that is included, will allow people to better protect themselves from water borne diseases. This would consequently lower mortality rates in third world countries, thereby lowering global health disparities. Future Work: After receiving approval from FDA and performing clinical trials, our team

would prepare to launch our product to market. For this, we would first need to find a funding source. This can be achieved by applying for a grant from an organization like the National Institute of Health or The Bill and Melinda Gates Foundation. Several of these US based associations offer financial support for global health projects. A possible strategy to adopt will be to launch this product in a fairly well developed city close to the targeted low-resource communities, and create awareness about the filter. We would also approach Non-Profit Organizations like Potters for Peace and Project Concern International to help promote our filtration device and help with its implementation. Through the support of these organizations, we would approach communities one at a time and recruit volunteers from the community to help out with installation of the filter. After instructing these community volunteers on the working and benefits of the clay-based filter, we would work on implementing this device in

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homes and work places. It would be helpful to instruct the community members on the use of this product in their local language, so that they understand the process easily and repeat it correctly. Throughout the process of implementation of the filter, we would spread awareness about the need to filter water and the impact of water-borne diseases.

References: [1] "Water Facts." Water.org. N.p., 2009. Web. 11 Mar 2011. <http://water.org/learn-about-thewater-crisis/facts/#water>. [2] "Household Water Treatment and Safe Storage." World Health Organization. N.p., 2011. Web. 11 Mar 2011. <http://www.who.int/household_water/en/>. [3] "The Millennium Development Goals Report." United Nations. N.p., 2010. Web. 11 Mar 2011.<http://www.un.org/millenniumgoals/pdf/MDG%20Report%202010%20En%20r 15%20-low%20res%2020100615%20-.pdf#page=60>. [4] "About." Potters for Peace. N.p., 2006. Web. 11 Mar 2011. <http://s189535770.onlinehome.us/pottersforpeace/>. [5] Yencho, Stephen. "Ultraviolet Water Purification System." United States Patent #7862728. (2011): Web. 12 Mar 2011. [6] "What is activated charcoal and why is it used in filters?" 01 April 2000. HowStuffWorks.com. Web. March 12, 2011. [7] "A National Drinking Water Clearing House Fact Sheet. "Tech brief. N.p., 14 Jun 2000. Web. 15 Mar 2011. [8] Vaysburg, Gita. "Water Filtration in Leifeng, China." (2006): 12. Web. 12 Mar 2011.

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[ 9 ] David A Sack, R Bradley Sack, G Balakrish Nair, AK Siddique, Cholera, The Lancet, Volume 363, Issue 9404, 17 January 2004, Pages 223-233, ISSN 0140-6736, DOI: 10.1016/S0140-6736(03)15328-7. <http://www.sciencedirect.com/science/article/ B6T1B-4BG8P11-V/2/0fa7d769a11d22a0f3a846cf80784d5d> [10] Flynn, Tony. "New lter promises clean water for millions." Australian National University. Australian National University, 19 Jan 2005. Web. 28 Feb 2011. <http://info.anu.edu.au/ovc/assets/claypotfilterfinalweb.pdf>.

[11] Eric Harshfield et. Al. Water Purification in Rural South Africa: Ethical Analysis and Reflections on Collaborative Community Engagement Projects in Engineering. International Journal for Service Learning in Engineering. Vol. 4, No. 1, pp. 1-14, Spring 2009. ISSN 1555-9033 [12] FDA 510(k) Submissions for Obtaining FDA Approval (Clearance). Emergo Group Company website. [13] Pre Market Approval Guidelines. US Food and Drug Administration. [14] Musezahl D, Christen A, Pacheco GD, Tellez FA, Iriarte M, et al. (2009) Solar Drinking Water Disinfection (SODIS) to Reduce Childhood Diarrhoea in Rural Bolivia: A Cluster-Randomized, Controlled Trial. PLoS Med 6(8): e1000125. doi:10.1371/journal.pmed.1000125

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