Difference between revisions of "Team:CSMU Taiwan/Safety"
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<div class="col-md-9"> | <div class="col-md-9"> | ||
<h3>Biosafety</h3> | <h3>Biosafety</h3> | ||
| − | <p>Our team complies | + | <p>Our team complies with the third edition of <a href="https://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf">Laboratory Biosafety Manual</a> released by World Health Organization.</p> |
<p>Moreover, according to Taiwan Centers for Disease Control(Taiwan CDC), some of the current status for Biosafety are stated as bellow:</p> | <p>Moreover, according to Taiwan Centers for Disease Control(Taiwan CDC), some of the current status for Biosafety are stated as bellow:</p> | ||
<br> | <br> | ||
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</div> | </div> | ||
| − | <p><b> What our team did to comply with it</b></p> | + | <p style="color:#009698"><b> What our team did to comply with it</b></p> |
<p>Although no select agents or toxins on the list are involved in our experiment, we still looked through the guidance carefully.</p> | <p>Although no select agents or toxins on the list are involved in our experiment, we still looked through the guidance carefully.</p> | ||
<p>Nucleoprotein and hemagglutinin of Influenza A and Influenza B virus are our target protein for SELEX, meanwhile whole influenza viruses are used to test the inhibition ability of our selected aptamers. In addition, in the Charactization and Improvement section, we improved the water solubility of HA1(Hemagglutinin for H1N1). The subtypes we chose are classified as seasonal influenza, which are surprisingly potential select agents too.</p> | <p>Nucleoprotein and hemagglutinin of Influenza A and Influenza B virus are our target protein for SELEX, meanwhile whole influenza viruses are used to test the inhibition ability of our selected aptamers. In addition, in the Charactization and Improvement section, we improved the water solubility of HA1(Hemagglutinin for H1N1). The subtypes we chose are classified as seasonal influenza, which are surprisingly potential select agents too.</p> | ||
<p>Apart from complying to the Biosafety manual for Level 2 labs, we also took some effort looking through Dual Use Research of Concern, DURC. After discussing with our instructor, we drafted a Risk mitigation plan.</p> | <p>Apart from complying to the Biosafety manual for Level 2 labs, we also took some effort looking through Dual Use Research of Concern, DURC. After discussing with our instructor, we drafted a Risk mitigation plan.</p> | ||
<br> | <br> | ||
| − | <p><b>2. Biosafety Mechanism Registration</b></p> | + | <p style="color:#009698"><b>2. Biosafety Mechanism Registration</b></p> |
<p>By December 2018, 502 entities reported biosafety management units to Taiwan CDC, of which 496 entities established biosafety committees and 6 entities designated a biosafety specialist staff. These included 20 government agencies, 153 medical institutions, 54 academic research institutions and 275 other groups.</p> | <p>By December 2018, 502 entities reported biosafety management units to Taiwan CDC, of which 496 entities established biosafety committees and 6 entities designated a biosafety specialist staff. These included 20 government agencies, 153 medical institutions, 54 academic research institutions and 275 other groups.</p> | ||
<p><b> What our team did to comply with it</b> | <p><b> What our team did to comply with it</b> | ||
| Line 194: | Line 194: | ||
<p>Since 2006, Taiwan CDC has routinely inspected BSL-3 and above laboratories to monitor operations and ensure safety. In 2009, TB-containment laboratories, which process culture manipulation for identification and drug-susceptibility tests, were added to inspections. In 2019, Taiwan CDC completed the annual routine laboratory biosafety and biosecurity inspecting of 22 high-containment laboratories (refers to Level 3 and Level 4 biosafety and animal biosafety laboratories.) and RG3 pathogens storage facilities.</p> | <p>Since 2006, Taiwan CDC has routinely inspected BSL-3 and above laboratories to monitor operations and ensure safety. In 2009, TB-containment laboratories, which process culture manipulation for identification and drug-susceptibility tests, were added to inspections. In 2019, Taiwan CDC completed the annual routine laboratory biosafety and biosecurity inspecting of 22 high-containment laboratories (refers to Level 3 and Level 4 biosafety and animal biosafety laboratories.) and RG3 pathogens storage facilities.</p> | ||
<p> In addition, Taiwan CDC supervised the local government health bureaus to complete the laboratory inspecting of 75 BSL-2 microbiology laboratories of biotechnology industries. In order to strengthen biosafety and biosecurity of the entities that possess or use select agents and toxins, Taiwan CDC has counselled and visited the facilities of 7 entities in 2018.</p> | <p> In addition, Taiwan CDC supervised the local government health bureaus to complete the laboratory inspecting of 75 BSL-2 microbiology laboratories of biotechnology industries. In order to strengthen biosafety and biosecurity of the entities that possess or use select agents and toxins, Taiwan CDC has counselled and visited the facilities of 7 entities in 2018.</p> | ||
| − | <p><b> What our team did to comply with it</b></p> | + | <p style="color:#009698"><b> What our team did to comply with it</b></p> |
<p>All of our experiments regarding virus were conducted in the Biosafety Level-2 laboratories. Under the supervision of CDC, our instructor manages the lab strictly and obeys to all guidance written in the manual. For example, we were never allowed to enter the lab before putting on gloves, masks and lab coats. The wastes were always carefully collected and dispensed. Most importantly, our instructor seldom leaves us alone when performing experiments that could infect disease accidentally.</p> | <p>All of our experiments regarding virus were conducted in the Biosafety Level-2 laboratories. Under the supervision of CDC, our instructor manages the lab strictly and obeys to all guidance written in the manual. For example, we were never allowed to enter the lab before putting on gloves, masks and lab coats. The wastes were always carefully collected and dispensed. Most importantly, our instructor seldom leaves us alone when performing experiments that could infect disease accidentally.</p> | ||
<br> | <br> | ||
| Line 200: | Line 200: | ||
<p> | <p> | ||
<p>In 2018, 4 e-learning courses on laboratory biosafety were recorded. Taiwan CDC also organized 3 biorisk management and 3 select agents and toxins training course sessions, with a total attendance of 429 laboratory workers. Taiwan CDC developed “Laboratory biosafety management information system” (ver. 2.0) which helps to conduct and oversee the condition of management of storage and transformation of infectious biological material. We held 10 operation training and 2 systematic data maintenance symposiums to help all entities getting familiar with the system, and 508 laboratory workers attended.</p> | <p>In 2018, 4 e-learning courses on laboratory biosafety were recorded. Taiwan CDC also organized 3 biorisk management and 3 select agents and toxins training course sessions, with a total attendance of 429 laboratory workers. Taiwan CDC developed “Laboratory biosafety management information system” (ver. 2.0) which helps to conduct and oversee the condition of management of storage and transformation of infectious biological material. We held 10 operation training and 2 systematic data maintenance symposiums to help all entities getting familiar with the system, and 508 laboratory workers attended.</p> | ||
| − | <p> | + | <p style="color:#009698"><b> What our team did to comply with it</b></p> |
<p>We have organized to watch these videos when facing the same situations the videos focused on. </p> | <p>We have organized to watch these videos when facing the same situations the videos focused on. </p> | ||
<br> | <br> | ||
| Line 209: | Line 209: | ||
<p><b>Future Prospects</b></p> | <p><b>Future Prospects</b></p> | ||
<p>Taiwan CDC has participated in the Global Health Security Agenda (GHSA) for several years and realized the international concern of Biological Select Agents and Toxins (BSAT). In 2016, we applied JEE Tool (Joint External Evaluation Tool) published by WHO to assess the epidemic prevention system of our nation which includes reviewing the level of BSAT management. For the JEE Tool, the highest score for each indicator is score 5-sustaninable. Taiwan was scored 3-developed capacity in BSAT management. As a result, by 2018, Taiwan CDC has improved the insufficiency of BSAT management and has made a great progress on it. We believe by the time of 2020, we will reach a higher score on BSAT management on JEE tool, to prove the nation’s ability of managing BSAT can be as well as other advanced countries.</p> | <p>Taiwan CDC has participated in the Global Health Security Agenda (GHSA) for several years and realized the international concern of Biological Select Agents and Toxins (BSAT). In 2016, we applied JEE Tool (Joint External Evaluation Tool) published by WHO to assess the epidemic prevention system of our nation which includes reviewing the level of BSAT management. For the JEE Tool, the highest score for each indicator is score 5-sustaninable. Taiwan was scored 3-developed capacity in BSAT management. As a result, by 2018, Taiwan CDC has improved the insufficiency of BSAT management and has made a great progress on it. We believe by the time of 2020, we will reach a higher score on BSAT management on JEE tool, to prove the nation’s ability of managing BSAT can be as well as other advanced countries.</p> | ||
| − | <p><b> What our team did to comply with it</b></p> | + | <p style="color:#009698"><b> What our team did to comply with it</b></p> |
<p>Not only did our team complied with the rules, we aimed to contribute to elevate the biosafety of lab and public health. In the section of design, we developed an AI system that is able to predict the spread of influenza.</p> | <p>Not only did our team complied with the rules, we aimed to contribute to elevate the biosafety of lab and public health. In the section of design, we developed an AI system that is able to predict the spread of influenza.</p> | ||
<p style=color:#009698><b>To sum up, since our experiment involves in virus experiments, we paid special attention towards this issue to secure the safety for both the researchers and public.</b></p> | <p style=color:#009698><b>To sum up, since our experiment involves in virus experiments, we paid special attention towards this issue to secure the safety for both the researchers and public.</b></p> | ||
Revision as of 06:36, 14 October 2019
Introduction
The ultimate aim of technology is to create a better world for human beings. However, risks arise during the development of these techniques, varying from physical harm to privacy invasion. The advantages of technology can never be fully demonstrated if these potential hazards presents, therefore, safety should be of the top priority no matter for researchers or users.
Our team aims to develop a more essential influenza rapid test tool. Meanwhile, creation of a new diagnostic tool takes more than research and development. Implementation of such a device means it will be brought into direct contact with society. To ensure that our work is safe for the end user and to prevent miscommunication about the purpose of the technology, it is also essential to consider the social aspects that our tool will bring.
To sum up, in the safety section, we are going to explore four different aspects of our project, respectively Biosafety, Lab Safety, Regulations, and Ethics.
Biosafety
Labsafety
Regulations
Ethics
Biosafety
Our team complies with the third edition of Laboratory Biosafety Manual released by World Health Organization.
Moreover, according to Taiwan Centers for Disease Control(Taiwan CDC), some of the current status for Biosafety are stated as bellow:
In 2018, Taiwan CDC completed editing, revision, and announcement of the “Guideline for Governing Management of Select Agents and Toxins”, “Guidance on the Inventory of Select Agents and Toxins”, “Security Guidance for Select Agent or Toxin Facilities”, “Guidance for Suitability Assessments”, “Drills and Exercise Guidance”, and “Select Agents or Toxins Biosafety/ Biocontainment Plan Guidance”. We also accomplished the amendment of the “Regulations Governing Management of Infectious Biological Materials” on January 31, 2019, categorizing select agents and toxins as a special section.
What our team did to comply with it
Although no select agents or toxins on the list are involved in our experiment, we still looked through the guidance carefully.
Nucleoprotein and hemagglutinin of Influenza A and Influenza B virus are our target protein for SELEX, meanwhile whole influenza viruses are used to test the inhibition ability of our selected aptamers. In addition, in the Charactization and Improvement section, we improved the water solubility of HA1(Hemagglutinin for H1N1). The subtypes we chose are classified as seasonal influenza, which are surprisingly potential select agents too.
Apart from complying to the Biosafety manual for Level 2 labs, we also took some effort looking through Dual Use Research of Concern, DURC. After discussing with our instructor, we drafted a Risk mitigation plan.
2. Biosafety Mechanism Registration
By December 2018, 502 entities reported biosafety management units to Taiwan CDC, of which 496 entities established biosafety committees and 6 entities designated a biosafety specialist staff. These included 20 government agencies, 153 medical institutions, 54 academic research institutions and 275 other groups.
What our team did to comply with it
We are proud to announce that our institution, Chung-Shan Medical University, is one of the registered entity! We have applied for agreement to use virus in our experiment at the safety committee of CSMU, and the safety committee checked our facility, gave us a quiz regarding associated operations before permitting us. In addition, CDC tracks our usage regarding all contagious agents including influenza virus.
3. Biosafety Inspections of High-Containment Laboratories
Since 2006, Taiwan CDC has routinely inspected BSL-3 and above laboratories to monitor operations and ensure safety. In 2009, TB-containment laboratories, which process culture manipulation for identification and drug-susceptibility tests, were added to inspections. In 2019, Taiwan CDC completed the annual routine laboratory biosafety and biosecurity inspecting of 22 high-containment laboratories (refers to Level 3 and Level 4 biosafety and animal biosafety laboratories.) and RG3 pathogens storage facilities.
In addition, Taiwan CDC supervised the local government health bureaus to complete the laboratory inspecting of 75 BSL-2 microbiology laboratories of biotechnology industries. In order to strengthen biosafety and biosecurity of the entities that possess or use select agents and toxins, Taiwan CDC has counselled and visited the facilities of 7 entities in 2018.
What our team did to comply with it
All of our experiments regarding virus were conducted in the Biosafety Level-2 laboratories. Under the supervision of CDC, our instructor manages the lab strictly and obeys to all guidance written in the manual. For example, we were never allowed to enter the lab before putting on gloves, masks and lab coats. The wastes were always carefully collected and dispensed. Most importantly, our instructor seldom leaves us alone when performing experiments that could infect disease accidentally.
4. Laboratory Biosafety Education and Training
In 2018, 4 e-learning courses on laboratory biosafety were recorded. Taiwan CDC also organized 3 biorisk management and 3 select agents and toxins training course sessions, with a total attendance of 429 laboratory workers. Taiwan CDC developed “Laboratory biosafety management information system” (ver. 2.0) which helps to conduct and oversee the condition of management of storage and transformation of infectious biological material. We held 10 operation training and 2 systematic data maintenance symposiums to help all entities getting familiar with the system, and 508 laboratory workers attended.
What our team did to comply with it
We have organized to watch these videos when facing the same situations the videos focused on.
5. Laboratory Biorisk Management
In 2018, the bio-risk management system using CWA 15793 standard was introduced to 17 biotechnology-relatived microbiology laboratories. By focusing on continuous improvement and the Plan-Do-Check-Act (PDCA) cycle, this system will identify and monitor all aspects of laboratory biosafety and biosecurity.
Future Prospects
Taiwan CDC has participated in the Global Health Security Agenda (GHSA) for several years and realized the international concern of Biological Select Agents and Toxins (BSAT). In 2016, we applied JEE Tool (Joint External Evaluation Tool) published by WHO to assess the epidemic prevention system of our nation which includes reviewing the level of BSAT management. For the JEE Tool, the highest score for each indicator is score 5-sustaninable. Taiwan was scored 3-developed capacity in BSAT management. As a result, by 2018, Taiwan CDC has improved the insufficiency of BSAT management and has made a great progress on it. We believe by the time of 2020, we will reach a higher score on BSAT management on JEE tool, to prove the nation’s ability of managing BSAT can be as well as other advanced countries.
What our team did to comply with it
Not only did our team complied with the rules, we aimed to contribute to elevate the biosafety of lab and public health. In the section of design, we developed an AI system that is able to predict the spread of influenza.
To sum up, since our experiment involves in virus experiments, we paid special attention towards this issue to secure the safety for both the researchers and public.
Images 1-2. On the left, Roger explaining Marc how to deal with chemical containers, on the right, the containers which CGROM manage.
As an additional safety measure we use SYBR Safe instead of Eidium bromide. Its use is identical in all the protocols but without carcinogenic risks.
Access to the laboratory
As we are a multidisciplinary team formed by biotechnologists, engineers and artists, not everybody knows how to behaviour in a laboratory. That is why we did several seminars directed by Alejandro Vignoni and Yadira Boada to teach the basics of their laboratory. However, as a security measure, they decided that not everybody would be allowed to work in the lab alone, only biotechlogists and biomedical engineers could be there without surveillance due to their experience and knowledge adquiered during their degree.
Over the course of these seminars we were informed about the evacuation protocols, waste management and our rights and liabilities as UPV staff. These information can be seen in the information sheets they gave us and that you can download through these buttons:
Strains
Printeria uses E.coli and V.natriegens as chassis. Both are classified as risk 1 so the harm which can cause to people is minimal. The E.coli are from strains DB3.1, 10G and TOP10, for V.natriegens we use the strain ATCC 1404 from CECT (Colección Española de Cultivos Tipo). To do constructions we use biobricks and parts supplied by IDT prepared with the Golden Gate grammar.
Labsafety
Paris-Bettencourt 2012 team was right when they said in their page "How safe is safe enough?": “Biosafety is an exciting design challenge, an essential enabling technology for synthetic biology, and a fundamental ethical obligation of all bioengineers”.
This sentence describes perfectly what we did with Printeria. Printeria was designed to ensure safety for all audiences, to be safe enough for the world. In the next table you can see different safety problems we saw with our instructors help, and how we solved them.
|
Safety Problem |
Implemented solution |
|---|---|
|
Sterilization of the PCB |
How do we clean the PCB (Printed Circuit Board) without damaging metalic and plastic components? Well, we decided to copy what flow cabins do. Based on this, we decided to use UV led lights to achieve this objective. This idea was given by Mojica as a part of our intergrated human. Furthermore we have programmed an especial reaction that use little droplets with HCl and ethanol to clean and ensure we have perfectly sterilized the PCB which is protected by a plastic film as well and this feature prevents acid from attacking it. |
|
Sterilization of the microfluidic tubes |
The reaction fluid is going to pass through microfluidic tubes and it will contaminate them. To reverse this situation we will use the same special program wich usses droplets with ethanol and HCl. |
|
Protection of the user |
We want users to see what is happening inside Printeria but also we want them to be protected if something wrong happens inside. That is why we thought that a metacrilate box that covered the machine would be a nice option. Besides, it is useful to pin up the elements which will be part of Printeria. |
|
Overheating of the PCB |
As the PCB has a cold and a hot zone, it is necessary to evacuate the heat generated. The hot zone can achieve more than 80º degrees and can be a potencial danger. A resistance is responsible of heating, and a peltier plate is responsible of chilling. Peltier effect is based in a semiconductor metal where you apply a potential difference. Then, you create a hot part and a cold one in that semiconductor. We use the cold part to extract the energy and stabilize the temperature via conduction of the PCB's hot zone. |
|
Ventilation |
The peltier plate is responsible of chilling the PCB but how do we evacuate all the energy generated? Well, the answer is simple, Printeria just needed ventilation holes and watercooling to do it. Watercooling is based in the higher termic capacity of fluids (water in this case) to absorb energy. Water is pumped through microfluidic tubes to reach the peltier and chill it. |
|
Electroporator |
This device is capable to reach high voltages, so if you require one of these in your design first of all, ensure no one can harm himself/herself. This is the reason why we designed our own electroporator in a dedicated and compacted printed circuit to isolate it from any exposure. It can reach until 1600V, which is not a joke. |
|
Tips |
Tips which go in the revolver wheel are disposable to ensure the purity of each reaction. |
Regulations
Science without ethics is cruel, and ethics without science is empty. Ethics become really important when a project is being thought. For this reason we wanted to pass the UPV (Polytechnic University of Valencia) ethics committee. Here you can download the document we sent them to approve and the positive veredict of the committee.
Ethics
Science without ethics is cruel, and ethics without science is empty. Ethics become really important when a project is being thought. For this reason we wanted to pass the UPV (Polytechnic University of Valencia) ethics committee. Here you can download the document we sent them to approve and the positive veredict of the committee.
References
1. Dual use: A report by iGEM team Bielefeld-CeBiTec 2015. [Germany]. Universität Bielefeld, . 30 pages.