What is bsl 3 lab

Biosafety Level 3 is applicable when diagnostic or research work is performed with zoonotic pathogens that may be harmful to humans or for which there is a strict requirement for containment. The BSL 3 laboratory is certified by DAFF and contains all the necessary equipment to protect both researchers and the environment against exposure to pathogens like avian influenza and Rift Valley fever viruses and the prion that causes BSE that might be contained in diagnostic samples.

Biosafety Level 3 is applicable to clinical, diagnostic, teaching, research, or production facilities in which work is done with pathogens which may cause serious or potentially lethal disease in humans or animals because of exposure through contaminative contact or inhalation.

Working with BSL3 pathogens avian influenza, rift valley fever, etc. Failure to meet any of these expectations will result in removal of BSL3 access privileges.

The facility has a refined ventilation system with HEPA filters that maintains negative room pressure to allow the containment of infectious agents and to facilitate decontamination through the ducting with the separation of rooms into the control room, change room, shower room and two separate working sections Virology and the PCR sections. It is also build with an Effluent Decontamination System EDS where heat sterilization processes are used to change the properties of the wastewater by removing harmful substances in order to turn it into clean water that can be safely discharged into the environment municipal sewage system.

A preliminary finish schedule and required material selection for the hardware, and other construction requirements should be finalized. Preparation of construction document with final specifications is essential at this stage. The final proposal with drawings and all other details including specifications of the essential and stand-alone equipment for release of funds should also be put forward so that tenders can be advertised.

Tender must be customized to select a professional organization, having experience of constructing this kind of laboratory. Some of the construction documents setting basic criteria and requirements for this facility should be part of the tender document.

Major documents to be included are general conditions of contract, description and scope of work, qualification criteria, instructions to bidders and evaluation of bids, and notice inviting tender. Finding and hiring the right construction agency for the facility is the key to success of the project. The construction agency with adequate qualification and expertise helps in making the containment laboratory functional and achieve standards of biosafety practices for safer working environments.

While hiring the construction agency for the proposed facility, one should ensure that the bidder meets the following minimum essential qualification criteria: i the minimum average annual turnover during the last three financial years as per their audited balance sheets should be at adequate level for making it sure that agency would be able to complete the project.

The ability of construction agency for designing and planning, correct evaluation of architectural layout plans, men and material movement plans, zoning plans, specialized systems and services schemes, services and utilities schemes, laboratory commissioning and validation protocols, laboratory security protocols and integration of laboratory and equipment should be assessed.

After satisfactorily meeting the qualification criteria, before awarding the contract to the construction agency, an agreement should be signed specifying all the requirements and guidelines to be followed, mentioning the time limit given for the completion of the project and the penalty clause, if not completed in time.

One of the major difficulties being encountered is non availability of typical regulations, codes and standards for a high standard construction which is required for such a laboratory. Also the International standards are not easy for the contractors and engineers to understand, since they do not illustrate implementation of these standards.

Hence, quality of construction must be supervised by a competent agency or group of engineers. If required, the project staff should be sent for onsite training at other laboratories. Development of scientific and engineering SOPs for the operation and maintenance should be started at this stage. Construction supervision by local engineering department may be arranged. Procurement and placement of other essential equipment required to functionalize the laboratory should also be done at this stage.

While ordering equipment, care should be taken to understand their installation, calibration, requirements and essential details for its maintenance.

The staff requirement includes one maintenance in-charge, one HVAC technician, one electrical technician, one person for instrumentation and staff for general building and services maintenance. A well trained person on biosafety and biosecurity should be the in-charge of the facility with one or two well trained technical staff.

Box 2 lists equipment in BSL-3, laboratory. Commissioning of the facility : The commissioning process of the laboratory includes three phases:.

It should be repeated and demonstrated to authorized person or project management consultant for the facility. On completion the laboratory is to be made functional, ready for take over. Commissioning procedure for the laboratory should be well designed and implemented to verify the safe facility operation. Taking over the facility includes verfying all the basic requirements as per the approved layouts, electrical connections raw, essential and UPS , local area network LAN connections, servers, water connections, sewage connection, hardware fitting, telephones and intercoms, functioning of the BMS with all the desired parameters, fine setting of access control and all the inventories.

On-site essential component and importance of training of the staff in advance : An integral component in setting-up the BSL-3 laboratory is designating an experienced and qualified Biosafety Officer and the Scientist-In-charge for the overall functioning i.

In-house staff training periodically with provision of safety drills is to be conducted every six months. As the laboratory construction is custom-made as per the requirement of the user, specific training programme should be developed to cater to the needs of that specific laboratory. Besides general biosafety training programme, laboratory specific training programme should also be prepared.

Training programmes and protocols must be developed by the Biosafety Officer and In-charge of the facility. SOPs for All the equipment, and laboratory working, and clinical sample handling and processing protocols must be developed.

Validation of the developed SOPs is also a mandate that needs to be taken care of by the designated person. Another issue of great concern is the development and testing of emergency protocols that should be strategically designed from the very beginning of the construction plans.

The staff working within the containment laboratory must be well-trained in the concepts and practices of the biosafety and biosecurity. Laboratory workers should be trained to understand and tackle any kind of emergency situations within the containment laboratory without panic while ensuring their own safety first and ensuring that laboratory equipment are put into safe operating mode.

Filing the incident report, assessment and management must be ensured for future risk assessment and management. Operation phase of the laboratory : After taking over, the training programmes for the staff should be implemented. The completion of training programmes follows the mock drills and validation of all the SOPs of the on-site and stand-alone equipment, followed by training from the contractor on the facility operations equipment. After obtaining approvals from the local statutory authorities like the Fire Department and municipal corporation, the laboratory can be put into operation.

Once this is achieved, the laboratory can go into validation phase. Operation of the facility, preparation of essential documents and programmes for validation : While the facility is being completed, some important documents certifying compliance with the international guidelines need to be prepared. Validation document includes commissioning reports of all major equipment, important SOPs of laboratory workflow, equipment use, and engineering controls AHU filters changing and operating records and main engineering controls , maintenance servicing, calibration and validation , decontamination and emergency protocols and other SOPs.

The training programme should cover all the basic and specific training modules, training imparted report and list of trainees with assessment results. To maintain all records for all equipment, log books, certification details and maintenance report book should be available in the laboratory.

Other documents should include entry and exit record sheets, entry of shower printouts from access control, records of daily checks, requisition file, and equipment calibration file. During validation procedure the methods of decontamination and their records should be presented with the details of tests done spores strips validation of autoclaves, area fumigation records and surface swab tests.

Facility and operation manuals should be prepared in such a way that these explain not only maintenance of engineering system but also the biosafety aspects. Documents should also describe the mandate and features of the facility. A technical manual of the facility should be prepared for good performance. Operation and maintenance of BSL-3 laboratory : After completion of validation procedure and acquiring certificate to use the facility, it goes in safe running operation mode.

The major maintenance requires re-review of the contingency plan for emergency during regular operation mode, so that any possible failure of any ongoing controls can be handled without breaching biosafety such as BMS, UPS, DG set and autoclaves. In case of non-sustainability of emergency, contingency plan for exit should be evolved.

This committee also looks into the biosafety aspects including experimentation and containment issues 5 , Annual Maintenance Contracts AMC of all important equipment should be done in advance to ensure continuity of routine maintenance. A contract should be made for maintenance of the facility by facility contractor to maintain and train the engineering personnel for future.

Memorandum of understanding should be signed with the contractor and sub-contractors for providing support for at least five years for the spares and services as and when needed 2 , 16 , 17 , 18 , The establishment of a containment laboratory is by and large a learning experience in India.

This article provides some guidance on roles and responsibilities for those who are planning to establish such facilities. This will also promote awareness about the roles and responsibilities of different team members to be involved in establishment of BSL-3 facilities. There are no national agencies in India to audit and validate BSL-3 laboratories.

The management of biosafety programme in such laboratories is to be accorded highest priority. It was out of the scope of this paper to touch upon such issues. Also, there are no national guidelines or standards available for operation and maintenance of BSL-3 laboratories. There is need to formulate such guidelines and establish agencies, which can help in managing biocontainment programmes in the country. National Center for Biotechnology Information , U.

Indian J Med Res. Devendra T. Mourya , Pragya D. Pragya D. Devendra S. Author information Article notes Copyright and License information Disclaimer. Reprint requests : Dr D. Received May This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.

This article has been cited by other articles in PMC. Abstract Since the enactment of Environmental Protection Act in and Department of Biotechnology DBT guidelines to deal with genetically modified organisms, India has embarked on establishing various levels of biosafety laboratories to deal with highly infectious and pathogenic organisms.

Keywords: Biosafety, biosecurity, BSL-3, construction, containment, laboratory, operation, validation. Introduction Biosafety is a major concern in every biomedical and medical setting across the world. Classification of laboratories on biosafety levels The concept of developing such laboratories resides within the principles of biosafety and biosecurity.

Table Hazardous microorganisms rules published in the Gazette No. Open in a separate window. Box 1 Action plan for the establishment of BSL-3 laboratory. Pre-requisites for construction A clear and detailed outline of scientific framework, objectives, pre-requisites manpower, space and funding , plan for proper utilization of the facilities should be made before preparing conceptual proposal.

Different types of BSL-3 have been described and some important features are summarized below, which can be considered while planning for that type of BSL-3 laboratory: BSL-3 laboratory with anteroom or workroom as an access zone : A simplest BSL-3 facility includes a two-space facility with an entry door from an access internal laboratory corridor into an anteroom, which can serve as an access zone for the BSL-3 laboratory of the facility.

Financial assistance for medically necessary services is based on family income and hospital resources and is provided to children under age 21 whose primary residence is in Washington, Alaska, Montana or Idaho. For more information, see Website Privacy. Skip to navigation menu Skip to content. High Priority Alert. Close alert. Informational Alert. Home Research Researcher Resources. Also in This Section….