• 제목/요약/키워드: Biosafety laboratory

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BSL2 Audit and Certification Program: An Effort to Harmonize and to Raise Standards in Both Laboratory Infrastructure and Biosafety Practices in Singapore

  • Tin, Tun;Lee, Kien Wah
    • 대한의생명과학회지
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    • 제22권3호
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    • pp.65-74
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    • 2016
  • The critical aspects of biosafety and bio-containment have been increasingly important in recent years. Biological agents involved in biological research projects at the Nanyang Technological University (NTU) Singapore are usually those with low risks. Biosafety level 2 or BSL 2 laboratories are widely used. However, biosafety measures which refer to the implementation of laboratory practices and procedures, specific construction features of laboratory facilities and safety equipment must be in place to reduce the exposure of laboratory personnel, the public or the environment to potentially infectious agents or other biological hazards. It is also required to pay more attention to laboratory-acquired infections (LAIs) which may occur in research laboratories, clinical laboratories or animal facilities. BSL 2 audit and certification program is implemented as an internal exercise covering laboratories in the university where biological agents are handled or biological research works are carried out. We have put some efforts to raise biosafety standards university-wide in both laboratory infrastructure and laboratory practices to a higher level. Common audit findings are briefly discussed in this presentation.

Status of Laboratory Biosafety and Biosecurity in Veterinary Research Facilities in Nigeria

  • Odetokun, Ismail Ayoade;Jagun-Jubril, Afusat Toyin;Onoja, Bernard A.;Wungak, Yiltawe Simwal;Raufu, Ibrahim Adisa;Chen, Jessica Corron
    • Safety and Health at Work
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    • 제8권1호
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    • pp.49-58
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    • 2017
  • Background: This study determined current status of laboratory biosafety in Nigerian veterinary research facilities. Methods: A questionnaire was developed to obtain information from researchers across Nigeria from July 2014 to July 2015. Information regarding demographics, knowledge of laboratory biosafety, availability and proper use of personal protective equipment (PPE), any priority pathogens researched, attitude on and use of standard laboratory practices, and biosafety awareness was obtained using a numeric scoring system. Data were analyzed with descriptive statistics, and univariate and multivariate logistic regression. Results: A total of 74 participants from 19 facilities completed the questionnaire. General knowledge scores ranged from 3 to 28 (out of 28 possible points), with 94.6% of respondents receiving low scores (scores < mean + 1 standard deviation). Very few (17.6%) reported availability or use PPE. Many participants (63.5%) reported no access to biosafety level (BSL)-1-3 facilities. None reported availability of a BSL-4 facility. Knowledge scores pertaining to biosafety management practices ranged from 0 to 14 (out of 14 possible points) with 47.3% of respondents receiving good scores (scores > mean + 1 standard deviation). Only 16.2% of respondents (from four facilities) reported having biosafety officers. Rabies virus was the most researched pathogen (31.1% of respondents). The majority (71.6%) were unaware of laws guiding biosafety. Researchers [odds ratio (OR) = 18.0; 95% confidence interval (CI): 1.63, 198.5; p = 0.023], especially in BSL-2 (OR = 258.5; 95% CI: 12.71, 5256; p < 0.001) facility of research institute (OR = 25.0; 95% CI: 5.18, 120.6; p < 0.001), are more likely to have adequate access to and properly utilize biosafety devices and PPE. Conclusions: Current knowledge of laboratory biosafety is limited except among a few researchers.

국내 연구원들의 생물안전 개념에 대한 현황 (Laboratory Biosafety Status of Researchers in Korea)

  • 김대식;김미경
    • 대한임상검사과학회지
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    • 제50권1호
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    • pp.71-76
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    • 2018
  • 본 연구는 2017년 1월 3일~3월 25일까지 실험실 연구자를 대상으로 생물 안전성에 대한 현황 연구를 목적으로 한다. 국내 감염병 병원체 취급대학 및 의과대학 소속 실험실에서 병원성 미생물을 취급하는 실험실 연구자 총 500명을 설문 조사하여 실시되었다. 조사 결과에 따르면 응답자는 높은 수준의 인지도를 보였으나 전반적인 생물 안전성 규칙 및 규정을 준수하지는 않았다. 실험실의 생물안전 시설의 등급 여부에 관한 문항에 관한 질문에는 '알고 있다'가 55.8%,'모른다'가 44.2%로 나타났다. 연구자들은 적절한 안전 조치가 개인을 보호 할 수 있으며, 안전 장비와 생물 안전 계획이 충분하지 않음에도 실험실이 안전하다고 믿었다. 생물안전 교육에 관련된 조사에서 연구자의 80%는 실험실 안전에 대한 교육을 받은 경험이 있었고 20%는 안전교육을 받은 적이 없었다. 생물안전교육에 대한 필요성은 66%, 교육내용에 대한 만족도는 46%로 나타났다. 이러한 결과는 연구자들은 이미 생물안전교육을 받은 경험이 있지만 지속적인 교육이 필요한 것으로 생각하였다. 또한 생물 안전성 수준을 향상시키는데 있어 가장 중요한 것은 훈련 프로그램 및 교육시스템을 강화하는 것이라는 의견이 있었다. 결론적으로 실험실에서 일어날 수 있는 위험에 대비하기 위한 실험실 생물 안전에 대한 보다 개선된 교육 시스템을 개발할 필요가 있다.

DESIGN GUIDELINE FOR BIOSAFETY LABORATORY CONSTRUCTION

  • Tzu-Ping Lo;Sy-Jye Guo
    • 국제학술발표논문집
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    • The 1th International Conference on Construction Engineering and Project Management
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    • pp.587-591
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    • 2005
  • The case of laboratory-acquired SARS Corona virus infection in Taiwan has revealed a number of weaknesses in management, construction, and oversight of laboratories. Also, with the increased demands for bio-safety laboratory, there is an urgent need to develop a uniform and comprehensive guidance for architects and construction engineers in the preparation of design and construction. This research investigates the key elements for designers, engineers, and potential owners in biosafety laboratory design and construction. It defines key elements and determines major relationships and standards that should be adhered to when developing site layout. In addition to layout planning and design guidance of biosafety laboratory, this research also interviews the perspective of architects and survey the state-of-the-art technology in Taiwan. It represents the portraits by site investigation. The purpose of the research is to provide guideline of design and avoid potential future conflict to ensure the critical continuity of functions.

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생물안전 3등급 연구시설의 구성 및 이용 (Composition and Use of Biosafety Level 3 Facility)

  • 김창환;허경행;이완걸;정성태
    • 한국군사과학기술학회지
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    • 제18권3호
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    • pp.335-342
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    • 2015
  • Laboratory facilities for biology are designed as biosafety level 1, biosafety level 2, biosafety level 3, and biosafety level 4. Biosafety level designations are based on a composite of the design features, construction, containment facilities, equipment, practice and operation procedures required for working with agents from the various risk groups. Generally, biosafety level 3 means the facility that is appropriate for the experiments using pathogens which can cause serious diseases by aerosol transmission. The biosafety level assigned for the specific work to be done is driven by professional judgement based on a risk assessment, rather than by automatic assignment according to the particular risk group designation of the pathogenic agents to be used. In this paper, we introduced the biosafety level 3 facility operated in ADD(Agency for defense development). It contains the overview of facility, microbiological experiment, animal experiment, decontamination and waste disposal. Biosafety level 3 laboratory in ADD has served the vital role in the research of biological agents and antidote development.

생물 안전 실험실의 자동제어 시스템 적용 사례 분석 (A Case Study on Biosafety Laboratory HVAC Control System)

  • 주영덕;김진;함호석
    • 대한설비공학회:학술대회논문집
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    • 대한설비공학회 2008년도 하계학술발표대회 논문집
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    • pp.84-89
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    • 2008
  • The biosafety laboratory HVAC control technology may be applied in order to protect contamination of the researcher, supervisor and to prevent diffusion of biological pollution. In this study, a biosafety level, general configuration of control system, differential pressure control, distributed control system and network structure were discussed. These systems able to increase laboratory safety and efficiency of HVAC system.

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Biosafety and Biosecurity Programme: Its Implementation, Requirements and Continuous Development at the Nanyang Technological University in Singapore

  • Tun, Tin;Preiser, Peter Rainer
    • 대한임상검사과학회지
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    • 제50권2호
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    • pp.77-84
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    • 2018
  • In Singapore, biosafety and biosecurity measures are controlled by the Biological Agents and Toxins Act (BATA) and other requirements by regulatory agencies. The law prohibits and otherwise regulates the possession, use, import, transhipment, transfer, and transportation of biological agents, inactivated biological agents, and toxins that are of public health concern. The law also defines the facility requirements for high risk biological agents and toxins. The containment facility (BSL 3) is a minimum requirement to handle biological agents that falls under Schedule 1 (Risk Group 3). The Nanyang Technological University School of Biological Sciences Biosafety Level 3 Facility (NTU-SBS BSL 3) was designed specifically for research involving potential hazardous biological materials. The facility requires yearly re-certification by an approved facility certifier to meet the local requirements and international biosafety standards for a containment facility in many instances. On the other hand, most NTU researchers conduct biological projects involving biological agents with low or moderate risk groups (Risk Groups 1 and 2 or biological agents described in schedule 3 and 4 of BATA) and GMOs, which need only a BSL 2 laboratory. BSL 2 laboratories are yet to be legally certified or registered in Singapore. Institutional Biosafety Committee (IBC) identifies the requirements; defines a minimum standard in the safe control of biological risks and registers all BSL 2 laboratories in the NTU. Therefore, under the guidance of the IBC, the University Biosafety and Biosecurity Programme includes the audit and certification program as a unique and an internal exercise to bring NTU biosafety to a higher level.

경영컨설팅 방법론을 이용한 감염병 실험실의 생물안전 위해성평가 조화기준 도출 (Development of a Harmonization Standard for Biosafety Risk Assessment of Infectious Disease Laboratories using Management Consulting Methodology)

  • 유민수
    • 한국환경보건학회지
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    • 제40권3호
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    • pp.187-203
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    • 2014
  • Objectives: As the demand to deal with pathogens in domestic research institutions has expanded and biological accidents have increased, the need for systematic biosafety management in infectious disease laboratories has grown. According to international standards, risk assessment (RA) is required for biosafety management. However, RA criteria have not been clearly established in Korea, so to this end I have attempted to determine RA criteria meeting international levels Methods: In order to provide RA criteria for application, I analyzed the RA criteria in use in the U.S., Europe and at international organizations. In order to ensure the public nature of the RA criteria, I constructed the research model through modified management consulting methodology reflecting the model of Radnor and O'Mahoney. Results: According to the results of the study, existing laboratory biosafety regulations were comparable to domestic laboratory safety laws. Existing laboratory biosafety standards that are designed around risk factors were found to be insufficient. An RA case to be carried out in infectious disease laboratories at the National Institute of Health of KCDC was identified. Conclusion: To establish a systematic risk management system meeting international standards, it was necessary first to harmonize the systems of national and international standards. In addition, in order to provide specific biosafety management on-site, I recognized a need for methodology and planning strategies to discover biosafety management so that it can be carried out as required through the RA of individual laboratories.

Uncertified Facility (BSL 2 plus): Its Journey through Life for Preparations and Setting up, Compliance with Biosafety Regulations, Implementation, and Registration of the Facility with the Ministry of Health, Singapore

  • Tun, Tin;Sim, Xander
    • 대한임상검사과학회지
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    • 제53권1호
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    • pp.68-80
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    • 2021
  • An uncertified facility is a facility not certified, as defined in the Biological Agents and Toxins Act (BATA) in Singapore, but has met the requirements of the Ministry of Health to possess First and Fifth Schedule biological agents and toxins. This type of facility is also known as a Biosafety Level 2 Plus (BSL 2+) facility. Registration as an uncertified facility or a BSL 2+ facility requires a certain process and procedure to be sought with the Biosafety Branch of the ministry. This review, shares first-hand knowledge on the journey to achieving registration of the authors' facility. The procedure involved considerable preparation, setting up facility requirements, biosafety precautions, procedures and practices, and training and competence of laboratory users. The ministry conducted a thorough onsite facility audit to ensure that the facility requirements and biosafety procedures and practices were in place. It then issued an approval letter of possession for the first-time use of biological agents and registered the laboratory as an uncertified facility. The expectation is that the comprehensive information shared may be of great benefit to other facilities with similar interests.

Biosafety Challenges for the Microbiology Laboratory

  • Montville, Thomas J.
    • 한국미생물생명공학회:학술대회논문집
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    • 한국미생물생명공학회 2005년도 2005 Annual Meeting & International Symposium
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    • pp.66-70
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    • 2005
  • Microbiology research must be conducted in a fashion that assures the health and well being of the researcher and the safety of the community. This lecture raises awareness of biosafety issues and discusses how the interaction of the pathogen being studied, the person conducting the research, and the practices being used can be manipulated to assure safety. The characterization of pathogens into Risk Groups, how these relate to Biosafety Levels, and the personal practices and laboratory design criteria associated with each Biosafety Level are explained. The importance of preventing or containing aerosols, limiting opportunities for cross-contamination, and taking a flexible multi-component approach to biosafety are emphasized.

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