Regulatory Compliance of a BSL-3 Laboratory Unit in a Drug Discovery Environment

Abstract

This publication describes the implementation and integration of a biosafety level 3 laboratory (BSL-3) unit within a drug discovery environment into a public multi-tenant and multi-user complex of buildings. The manuscript is intended to be used as guidance for any owners/users willing to build a laboratory unit of this type, including all steps from design to registration and certification. The goal of integrating a BSL-3 laboratory, according to international standards, with a drug development unit and an animal facility for infection studies, in a mixed multi-user and multi-tenant building, under circumstances where biosafety legislation is still under development, can lead to a complex situation with conflicting demands and expectations of the involved parties and the public. To solve the potential conflicts, an innovative approach was chosen to optimize the design of the laboratory (basing the safety concept on user requirements and qualifications criteria, and developing technical solutions in compliance with a consensus of the most relevant international biosafety regulations).We describe here the BSL-3 unit set-up, built for the Novartis Institute for Tropical Diseases (NITD), which moved in April 2004 to Biopolis in Singapore, where new laboratories compliant with international biosafety standards had to be set up. The project ran in six phases; after 14 months of construction and build-up, installation approval, commissioning and certification, the laboratory could be made available to users. After evaluation and approval of all Standard Operating Procedures (SOPs) with non-infectious agents, the laboratory could be used as a so-called "hot operation" with infectious agents.

The Design and Testing of a Continuous Effluent Sterilization System for Liquid Waste

“…(CDC, 2007;Fleming & Hunt, 2007;PHAC, 2004), but also on the types of pathogens intended to be handled within these facilities (Behrmann et al, 2007). An important consideration in the design and use of these facilities, in particular for Biosafety Level 3 and 4 facilities, is the treatment of waste water, which is integrated into global security and safety concepts.…”

“…The CED system was installed within the containment zone of a Biosafety Level-3 (BSL-3) facility at the Novartis Institute for Tropical Diseases (NITD) in Singapore ( Figure 2; Behrmann et al, 2007). This model has a liquid waste tank capacity of 1000L.…”

Low Level of Awareness in Biosafety and Biosecurity among Professionals in Uganda: A Potential Risk in the Dual-Use Dilemma

“…The observation meant that a high level of exposure to hazardous agents could not be ruled out. Neglect of containment of microorganisms to prevent unintended release [15] is a great risk. Such a situation is worse in a country like Uganda, which often experiences outbreaks of some of the highly infectious zoonotic diseases such as Anthrax, Hepatitis B and E, Ebola and Marburg whose samples are supposed to be handled under biosafety level IV containment facilities and procedures [19,20], but are often first handled at much lower level facilities in the country.…”

“…Additionally, biosafety principles, technologies and practices help prevent unintentional exposure to pathogens and toxins, or their accidental release [16]. With these laboratory measures and modern biosafety legislation, all pathogenic or genetically modified organisms can be effectively blocked from release from a facility during handling [15]. Measures of biosecurity are in addition expected to ensure protection, control and accountability for valuable biological materials within laboratories, in order to prevent their unauthorized access, loss, theft and dual-use (misuse, diversion or intentional release) [1].…”

“…The fundamental assumption is that the unintended release of pathogenic or genetically modified organisms might exert major harm or pose non-quantifiable risks to human beings and the environment [15]. Additionally, biosafety principles, technologies and practices help prevent unintentional exposure to pathogens and toxins, or their accidental release [16].…”