• 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.

• 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.