Difference between revisions of "Team:CSMU Taiwan/Safety"

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                                             <p>
 
                                             <p>
 
                                                  
 
                                                  
                                         <div style="border: solid 1px;padding: 0 5px;"><p><li>Freeze Dryer:</li>
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                                         <div style="border: solid 1px;padding: 0 5px;"><p><b>Freeze Dryer:</b>
 
                                                 </p>
 
                                                 </p>
 
                                                 <p>The order to start the machine is of great importance. First, we should turn on the machine in the middle to warm it up for about 30-60 minutes. Then we turn the pump open. Note that if any water drop slides into the liquid, the pump will rise. Therefore, remember to drop the water droplets slowly from below.</p></div>
 
                                                 <p>The order to start the machine is of great importance. First, we should turn on the machine in the middle to warm it up for about 30-60 minutes. Then we turn the pump open. Note that if any water drop slides into the liquid, the pump will rise. Therefore, remember to drop the water droplets slowly from below.</p></div>
 
                                         <div style="border: solid 1px;padding: 0 5px;"><p>
 
                                         <div style="border: solid 1px;padding: 0 5px;"><p>
                                                     <li>Low Temperature High Speed Centrifuge:</li>
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                                                     <b>Low Temperature High Speed Centrifuge:</b>
 
                                                 </p>
 
                                                 </p>
 
                                                 <p>Balance is very important! Balance the weight before putting the samples into the machine. Do not mess with the tools provided by a different company from the machine manufacturer. For example, if we want to centrifuge with 15 cc centrifuge tube, we use the centrifugal sleeve provided by the manufacturer instead of plugging the tube into any other centrifugal sleeve. Under high speed centrifugation, unbalance could cause great damage to the middle shaft of the machine (which is the heart of it), and would be very dangerous to operators since the samples could burst out from the machine in a very high speed. Don’t put any thing on the machine when it is operating as well.</p></div>
 
                                                 <p>Balance is very important! Balance the weight before putting the samples into the machine. Do not mess with the tools provided by a different company from the machine manufacturer. For example, if we want to centrifuge with 15 cc centrifuge tube, we use the centrifugal sleeve provided by the manufacturer instead of plugging the tube into any other centrifugal sleeve. Under high speed centrifugation, unbalance could cause great damage to the middle shaft of the machine (which is the heart of it), and would be very dangerous to operators since the samples could burst out from the machine in a very high speed. Don’t put any thing on the machine when it is operating as well.</p></div>
 
                                         <div style="border: solid 1px;padding: 0 5px;"><p>
 
                                         <div style="border: solid 1px;padding: 0 5px;"><p>
                                                     <li>Laminar Flow (Hood):</li>
+
                                                     <b>Laminar Flow (Hood):</b>
 
                                                 </p>
 
                                                 </p>
 
                                                 <p>The flow should be turned on for at least 20 mins before usage. The hood must be pulled down when the UV lights are on.</p></div>
 
                                                 <p>The flow should be turned on for at least 20 mins before usage. The hood must be pulled down when the UV lights are on.</p></div>
 
                                         <div style="border: solid 1px;padding: 0 5px;"><p>
 
                                         <div style="border: solid 1px;padding: 0 5px;"><p>
                                                     <li>Autoclave:</li>
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                                                     <b>Autoclave:</b>
 
                                                 </p>
 
                                                 </p>
 
                                                 <p>Don’t put any PC materials into the machine or it could melt. Always remember to check if both the drainage knob and exhaust knob has been tightly closed before powering up the machine. Ensure that the door is fully sealed, however, don’t over-tighten the bolt as it may result in damage to the gasket. Before taking out the materials, turn the exhaust knobs loose. Gloves are necessary.</p></div>
 
                                                 <p>Don’t put any PC materials into the machine or it could melt. Always remember to check if both the drainage knob and exhaust knob has been tightly closed before powering up the machine. Ensure that the door is fully sealed, however, don’t over-tighten the bolt as it may result in damage to the gasket. Before taking out the materials, turn the exhaust knobs loose. Gloves are necessary.</p></div>
 
                                         <div style="border: solid 1px;padding: 0 5px;"><p>
 
                                         <div style="border: solid 1px;padding: 0 5px;"><p>
                                                     <li>Ultrasonic washer:</li>
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                                                     <b>Ultrasonic washer:</b>
 
                                                 </p>
 
                                                 </p>
 
                                                 <p>The volume of water column needs to be adjusted according to the black indicator line. The water will drain out if it exceeds the line .</p></div>
 
                                                 <p>The volume of water column needs to be adjusted according to the black indicator line. The water will drain out if it exceeds the line .</p></div>
 
                                         <div style="border: solid 1px;padding: 0 5px;"><p>
 
                                         <div style="border: solid 1px;padding: 0 5px;"><p>
                                                     <li>Micro scales:</li>
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                                                     <b>Micro scales:</b>
 
                                                 </p>
 
                                                 </p>
 
                                                 <p>Items must be placed in the middle of the scale. Always check the gradienter to see if the scale is standing at a horizontal platform .</p></div>
 
                                                 <p>Items must be placed in the middle of the scale. Always check the gradienter to see if the scale is standing at a horizontal platform .</p></div>
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                                                 <p>If you’re uncertain about any step during the experiment, STOP! Never feel embarrassed to ask for help !!</p>
 
                                                 <p>If you’re uncertain about any step during the experiment, STOP! Never feel embarrassed to ask for help !!</p>
 
                                                 <br>
 
                                                 <br>
                                                 <p><b>MSDS</b></p>
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                                                 <h3>MSDS</h3>
 
                                                 <p>Material Safety Data Sheet, MSDS. Every chemical, reagents in the lab are printed and collected in this data folder. The folder is placed in a significant place near the door, which is easy to find and read in case of emergency.</p>
 
                                                 <p>Material Safety Data Sheet, MSDS. Every chemical, reagents in the lab are printed and collected in this data folder. The folder is placed in a significant place near the door, which is easy to find and read in case of emergency.</p>
 
                                                 <br>
 
                                                 <br>
                                                 <p><b>Biohazard waste Management</b></p>
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                                                 <h3>Biohazard waste Management</h3>
 
                                                 <p>All kinds of waste produced in the working area of the laboratory are considered biohazard waste, including every experiment and consumptive material. Those biohazard wastes would be collected into a specially labelled red plastic bag, and be sent to the Environmental Safety and Health Center of Chung Shan Medical University for further disposure process.</p>
 
                                                 <p>All kinds of waste produced in the working area of the laboratory are considered biohazard waste, including every experiment and consumptive material. Those biohazard wastes would be collected into a specially labelled red plastic bag, and be sent to the Environmental Safety and Health Center of Chung Shan Medical University for further disposure process.</p>
 
                                                 <!----Empìezo listado con una separación---->
 
                                                 <!----Empìezo listado con una separación---->
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                                             <br>
 
                                             <br>
 
                                             <h3>1. Animal Health Research Institute Council of Agriculture, Executive Yuan</h3>
 
                                             <h3>1. Animal Health Research Institute Council of Agriculture, Executive Yuan</h3>
                                             <p>&nbsp;&nbsp;&nbsp;We learned regulations associated with influenza epidemic prevention. Since our product aims to extend the usage of our rapid test to avian flu, the researcher and the director of Epidemiology Division “Fan Lee” gave us lots of information regarding avian flu control in Taiwan. It is sad to know that although laws are established, the government actually faces challenges when carrying it out. It dawned on to us that our AI system would be of great help when facing this situation. <a href="https://2019.igem.org/Team:CSMU_Taiwan/Design#C" style="color:#009698">(see Design)</h2>
+
                                             <p>&nbsp;&nbsp;&nbsp;We learned regulations associated with influenza epidemic prevention. Since our product aims to extend the usage of our rapid test to avian flu, the researcher and the director of Epidemiology Division “Fan Lee” gave us lots of information regarding avian flu control in Taiwan. It is sad to know that although laws are established, the government actually faces challenges when carrying it out. It dawned on to us that our AI system would be of great help when facing this situation. <a href="https://2019.igem.org/Team:CSMU_Taiwan/Design#C" style="color:#009698">(see Design)</a></h2>
 
                                                     <h3>2. Adimmune Corporation’s Biotechnological Company<a href="https://2019.igem.org/Team:CSMU_Taiwan/Human_Practices#iHP">(iHP)</a></h3>
 
                                                     <h3>2. Adimmune Corporation’s Biotechnological Company<a href="https://2019.igem.org/Team:CSMU_Taiwan/Human_Practices#iHP">(iHP)</a></h3>
 
                                                     <p>&nbsp;&nbsp;&nbsp;We learned regulations regarding using virus in experiments and vaccine development including human clinical tests.</p>
 
                                                     <p>&nbsp;&nbsp;&nbsp;We learned regulations regarding using virus in experiments and vaccine development including human clinical tests.</p>
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                                                     <p>&nbsp;&nbsp;&nbsp;We learned the laws associated with Experiments &Product design(00:00), Commercialization and Market Launch(01:48), and public promotion(08:10) including the attribution of responsibility if any unexpected situation arises.</p>
 
                                                     <p>&nbsp;&nbsp;&nbsp;We learned the laws associated with Experiments &Product design(00:00), Commercialization and Market Launch(01:48), and public promotion(08:10) including the attribution of responsibility if any unexpected situation arises.</p>
 
                                                     <!-- put vedio -->
 
                                                     <!-- put vedio -->
                                                     <p><b>Experiment stage(00:00):</b></p>
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                                                     <h4>Experiment stage(00:00):</h4>
 
                                                     <p>&rarr;Submit Application<br>&rarr;Review Board determine from the feasibility of science and the safety of ethics in the projects(including visiting our lab to see if we meet the requirements of basic operation)<br>&rarr;reject/rewrite/adjust<br>&rarr;everything complies with the regulation<br>&rarr;move on to clinical trial</p>
 
                                                     <p>&rarr;Submit Application<br>&rarr;Review Board determine from the feasibility of science and the safety of ethics in the projects(including visiting our lab to see if we meet the requirements of basic operation)<br>&rarr;reject/rewrite/adjust<br>&rarr;everything complies with the regulation<br>&rarr;move on to clinical trial</p>
                                                     <p><b>Clinical Trial and Market Launch</b></p>
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                                                     <h4>Clinical Trial and Market Launch</h4>
 +
                                        <div style="border: solid 1px;padding: 0 5px;">
 
                                                     <p>Phase 0<br>&rarr;Pass the examination of Institutional Review Board, IRB <br>(complies to Declaration of Helsinki)
 
                                                     <p>Phase 0<br>&rarr;Pass the examination of Institutional Review Board, IRB <br>(complies to Declaration of Helsinki)
 
                                                         <a href="https://static.igem.org/mediawiki/2019/4/45/T--CSMU_Taiwan--helsinki.pdf"><br>Declaration of Helsinki</p>
 
                                                         <a href="https://static.igem.org/mediawiki/2019/4/45/T--CSMU_Taiwan--helsinki.pdf"><br>Declaration of Helsinki</p>
 
                                                 </a>
 
                                                 </a>
                                                 <p>Phase1: Ensure the safety<br>&rarr;Check the safe dosage<br>&rarr;Find a few patients and give them the medicine to see how effective it is<br>&rarr;Continue to adjust the dosage amount and other medicine related parameters<br>Phase 2: Drug Test<br>&rarr;Find a large amount of patients , see if the medicine achieve the safety and effectivity we expected<br>&rarr;the Ministry of Health and Welfare approves the result</p>
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 +
                                                 <p>Phase1: Ensure the safety<br>&rarr;Check the safe dosage<br>&rarr;Find a few patients and give them the medicine to see how effective it is<br>&rarr;Continue to adjust the dosage amount and other medicine related parameters
 +
                                        <div style="border: solid 1px;padding: 0 5px;">
 +
                                                <p>Phase 2: Drug Test<br>&rarr;Find a large amount of patients , see if the medicine achieve the safety and effectivity we expected<br>&rarr;the Ministry of Health and Welfare approves the result</p>
 +
                                        <div style="border: solid 1px;padding: 0 5px;">
 
                                                 <p>Phase 3<br>&rarr;Apply for marketing authorization of the government: Taiwan Food and Drug Administration, TFDA<br>&rarr;Get the Medicament license, then we can produce our products</p>
 
                                                 <p>Phase 3<br>&rarr;Apply for marketing authorization of the government: Taiwan Food and Drug Administration, TFDA<br>&rarr;Get the Medicament license, then we can produce our products</p>
 +
                                        <div style="border: solid 1px;padding: 0 5px;">
 
                                                 <p>Phase 4: Marketing<br>&rarr;Sell the products to the market<br>&rarr;Requires a long-term follow-up because most adverse drug reaction are unpredictable<br><br></p>
 
                                                 <p>Phase 4: Marketing<br>&rarr;Sell the products to the market<br>&rarr;Requires a long-term follow-up because most adverse drug reaction are unpredictable<br><br></p>
                                                <p><b>Patent Application</b></p>
+
                                        </div>
                                                 <ol>
+
                                                <h4>Patent Application</h4>
                                                    <li>Experiment Stage: </li>
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                                        <div style="border: solid 1px;padding: 0 5px;">
                                                     <ul style="list-style-type:disc;">
+
                                                 <p>Experiment Stage:
 +
                                                     <ul>
 
                                                         <li>Note if any protocol/design have the potential to apply for patent.</li>
 
                                                         <li>Note if any protocol/design have the potential to apply for patent.</li>
 
                                                         <li>Keep every record of the experiments.</li>
 
                                                         <li>Keep every record of the experiments.</li>
 
                                                     </ul>
 
                                                     </ul>
                                                     <li>Commercialize Stage:</li>
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                                        <div style="border: solid 1px;padding: 0 5px;">
 +
                                                     <p>Commercialize Stage:</p>
 
                                                     <ul style="list-style-type:disc;">
 
                                                     <ul style="list-style-type:disc;">
 
                                                         <li>Note if any of the process infringes other people’s patents, they could sue you</li>
 
                                                         <li>Note if any of the process infringes other people’s patents, they could sue you</li>
 
                                                         <li>Do a search to check if any patent already exists.<br>(Consult the Incubation Center of our Academy ) </li>
 
                                                         <li>Do a search to check if any patent already exists.<br>(Consult the Incubation Center of our Academy ) </li>
 
                                                     </ul>
 
                                                     </ul>
                                                </ol>
+
                                        </div>
 
                                                 <p><a href="https://2019.igem.org/Team:CSMU_Taiwan/Safety#Ethics" style="color:#009698"> See ethics for more about Associated Responsibilities</a></p>
 
                                                 <p><a href="https://2019.igem.org/Team:CSMU_Taiwan/Safety#Ethics" style="color:#009698"> See ethics for more about Associated Responsibilities</a></p>
 
                                                 <h3>4.The incubation center of Chung-Shan Medical University</h3>
 
                                                 <h3>4.The incubation center of Chung-Shan Medical University</h3>

Revision as of 08:24, 20 October 2019

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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:


1.  Legislative and Regulatory Changes

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.

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.


6. 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.

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