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BSL2 Audit and Certification Program
Tin Tun,Lee Kien Wah 대한의생명과학회 2016 Biomedical Science Letters Vol.22 No.3
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.
Tin Tun 대한의생명과학회 2017 Biomedical Science Letters Vol.23 No.3
Biomedical laboratory is full of risks. Risk could be biological, chemical, radioactive, mechanical, physical, fire and electrical. All possible risks need to be identified, evaluated and controlled. A risk management system must be in place to prevent accident or loss of lives and to improve overall workplace safety and productivity. Safety in laboratory is a combination of appropriate risk management system, engineering controls and technical facilities, administrative controls and safety procedures and practices. Laboratory safety culture must be developed so that exposure to hazards for laboratory personnel, community and environment will be minimized or eliminated. In this review, importance of safety in a biomedical laboratory and risk management will be discussed.
( Tin Tun ),( Peter Rainer Preiser ) 대한임상검사과학회 2018 대한임상검사과학회지(KJCLS) Vol.50 No.2
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.
Tun, Tin,Preiser, Peter Rainer Korean Society for Clinical Laboratory Science 2018 대한임상검사과학회지(KJCLS) Vol.50 No.2
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.
( Tin Tun ),( Xander Sim ) 대한임상검사과학회 2021 대한임상검사과학회지(KJCLS) Vol.53 No.1
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. Copyright Ⓒ 2021 The Korean Society for Clinical Laboratory Science. All rights reserved.