BIOLOGICAL SAFETY CABINET PROGRAM TABLE OF CONTENTS: 1. INTRODUCTION 2. PURPOSE AND SCOPE 3. SELECTION AND INSTALLATION 4. USE OF BIOLOGICAL SAFETY CABINETS 5. CERTIFICATION OF BIOLOGICAL SAFETY CABINETS 6. PROGRAM ADMINISTRATION 7. RESPONSIBILITIES _____________________________________________________________________________________________________________________________________ EHS-M-30 Issue Date: 11/05/07 Reviewed: MAR Page 1 of 7 Destroy Previous Revisions USC BIOLOGICAL SAFETY CABINET PROGRAM PAGE 2 of 7 1. INTRODUCTION The biological safety cabinets (BSC) are used at the University of South Carolina as a primary means of containment for working safely with infectious microorganisms. They act as primary barriers to prevent the escape of biological aerosols into the laboratory environment. This is an important function, because most laboratory techniques (e.g. pipetting, vortexing, sonicating) are known to produce inadvertent aerosols that can be readily inhaled by the laboratory worker. BSCs are only one part of an overall biosafety program which requires consistent use of good microbiological practices, use of a primary containment equipment and proper containment facility design. BSCs are designed, in varying combinations, for: Personnel Protection: Protects personnel from harmful agents inside the BSC. Product Protection: Protects the work, product, experiment or procedure performed in the BSC from contaminants in the laboratory environment or from cross contamination inside the cabinet. Environmental Protection: Protects the environment from contaminants contained in the BSC. There are three broad types of BSCs, each with varying degrees of protection: Class I BSCs provide personnel and environmental protection, but not product protection. It is similar in air movement to a chemical fume hood, but has a HEPA filter in the exhaust system to protect the environment. Class II BSCs provide personnel, environmental and product protection. Airflow is drawn into the front grille of the cabinet, providing personnel protection. In addition, the downward laminar flow of HEPA-filtered air provides product protection by minimizing the chance of cross-contamination across the work surface of the cabinet. Class II BSCs are appropriate for work with agents assigned to biosafety levels 1-3. This is the most common type of BSC used at USC. Class III BSCs are designed for work with highly infectious microbiological agents and provides maximum protection for the environment and the worker. Both supply and exhaust air are HEPA filtered. Class III BSCs are required for Biosafety Level (BSL) IV work. Currently, there is no BSL IV work in progress at USC, and there are no Class III BSCs installed. Laminar Flow Benches are designed for project protection only, and are never to be used when working with cell cultures or infectious materials. Annual certification of laminar flow benches is not required. 2. PURPOSE AND SCOPE The purpose of the BSC Program is to establish University policy for the selection, use, maintenance and certification of biological safety cabinets. _____________________________________________________________________________________________________________________________________ EHS-M-30 Issue Date: 11/05/07 Reviewed: MAR Page 2 of 7 Destroy Previous Revisions USC BIOLOGICAL SAFETY CABINET PROGRAM PAGE 3 of 7 3. SELECTION AND INSTALLATION The Class II, Type A2 BSC is the most commonly used cabinet in the USC research labs. This type of BSC provides personnel, product and environmental protection from hazardous particulates such as biological agents that require containment at Biosafety Level 1, 2 or 3. HEPA filtered exhaust air from a Class II, Type A2 BSC can be safely re-circulated back into the laboratory environment if the cabinet is tested and certified at least annually and operated according to manufacturer’s recommendations. BSCs can also be connected to the laboratory exhaust system by either a thimble (canopy) connection or a direct (hard) connection. This would allow for 100% of the filtered exhaust air to be discharged out of the laboratory. Since none of the air is re-circulated, these cabinets may be used for work with biological agents treated with volatile toxic chemicals. Provisions to assure proper safety cabinet performance and air system operation must be verified. The expense for installation and maintenance of a total-exhaust BSC is much higher, and therefore should only be selected and installed when justified based on the specific type of research being conducted in the lab. Any lab planning to purchase and install a total-exhaust cabinet (i.e. Class II, Type B2) should notify Environmental Health and Safety prior to ordering the cabinet. BSCs should be located away from doors, windows that can be opened, and heavily traveled laboratory areas. This will help to minimize air pattern disruption in the cabinet. Air supply diffusers or exhaust vents should not be placed directly over or in front of BSCs where the movement of air can affect the airflow of the cabinet. A 12 inch clearance should be provided behind and on each side of a BSC to allow easy access for maintenance, and to ensure that the air return to the laboratory is not hindered. Open flames, such as gas burners, should not be used in a BSC. The proper selection and installation of BSCs must be made in accordance with the most recent edition of Primary Containment of Biohazards: Selection, Installation and Use of Biological Safety Cabinets. This document is available online and is published jointly by the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, and National Institutes of Health. 4. USE OF BIOLOGICAL SAFETY CABINETS A properly certified and operational BSC is an effective engineering control which must be used in concert with appropriate work practices, procedures and other administrative controls to reduce the risk of exposure to infectious microorganisms. The following work practices and procedures should be in place when working in a BSC. (1) Planning • • Thoroughly understand procedures and equipment required before beginning work. Arrange for minimal disruptions, such as room traffic or entry into the room, while the cabinet is in use. (2) Start-Up • Turn off UV light if in use. Ensure that the sash is set in the correct operating position. _____________________________________________________________________________________________________________________________________ EHS-M-30 Issue Date: 11/05/07 Reviewed: MAR Page 3 of 7 Destroy Previous Revisions USC BIOLOGICAL SAFETY CABINET PROGRAM • • • • • • PAGE 4 of 7 Turn on fluorescent light and cabinet blower. Check the return air grilles for obstructions, and note the pressure gauge reading. Allow the cabinet to operate unobstructed for at least fifteen minutes. Wash hands and arms thoroughly with soap. Wear a long sleeved lab coat with knit cuffs and over-the-cuff gloves. Make sure that all waste containers are located inside the BSC before starting work. (3) Surface Decontamination (before work) • Wipe down the interior surfaces of the cabinet with 10% bleach, followed in 5 to 10 minutes with 70% ethanol to prevent pitting of the stainless steel, and allow to dry. (4) Loading Materials and Equipment • • • Only load the materials required for the procedure. Do not overload the cabinet. Do not obstruct the front, side, or rear return air grilles. Large objects should not be placed close together. After loading the cabinet, wait two to three minutes to purge airborne contaminants from the work area. (5) Work Techniques • • • • • • • • Keep all materials at least four inches inside the sash, and perform all contaminated operations as far to the rear of the work area as possible. Segregate all clean and contaminated materials in the work area and arrange materials to minimize the movement of contaminated materials into clean areas. Keep all discarded, contaminated material to the rear of the cabinet. Avoid moving materials or excessive motion of the operator’s hands and arms through the front access opening during use. Open flames SHOULD NOT be used. Use proper aseptic technique. Avoid using techniques or procedures that disrupt the air flow pattern of the cabinet. If there is a spill or splatter during use, all objects in the cabinet should be surface decontaminated before removal. Thoroughly disinfect the working area of the cabinet WHILE IT IS STILL IN OPERATION. This will prevent the release of contaminants from the cabinet. (6) Final Purging • Upon completion of work, the cabinet should be allowed to operate for three to five minutes undisturbed, to purge airborne contaminants from the work area. (7) Unloading Materials and Equipment • • • Disposable contaminated objects, including gloves, should be placed in disposal pans or autoclave bags inside the BSC after use. Reusable objects in contact with contaminated material should be surface decontaminated before removal from the cabinet. All open trays or containers should be covered before being removed from the cabinet. _____________________________________________________________________________________________________________________________________ EHS-M-30 Issue Date: 11/05/07 Reviewed: MAR Page 4 of 7 Destroy Previous Revisions USC BIOLOGICAL SAFETY CABINET PROGRAM PAGE 5 of 7 (8) Surface Decontamination – after work • Wipe down the interior surfaces of the cabinet with 10% bleach, followed in 5 to 10 minutes with 70% ethanol to prevent pitting of the stainless steel. 5. CERTIFICATION OF BIOLOGICAL SAFETY CABINETS (1) General Certification Requirements: (a) All Class II BSCs must be tested and certified at least annually to ensure continued proper operation. (b) All Class II BSCs will be tested and certified in accordance with specifications in NSF Standard 49 Annex “F” and the manufacturer’s specifications. (c) The operational integrity must be validated by certification before a newly installed BSC is used and after a BSC has been repaired or relocated. (d) After a BSC has been certified, a label will be prominently affixed to the front of the BSC, displaying the date of certification and name of the certifier. (e) One copy of the certification report will be provided to the laboratory staff. (f) Only NSF accredited field certifiers will be used to test and certify BSCs. (2) Certification Requirements for Class II BSCs. All Class II BSCs will be tested and certified as per NSF/ANSI 49 – 2004 specifications, including: (a) Downflow Velocity and Volume Test (b) Inflow Velocity Test (c) Airflow Smoke Patterns Test (d) HEPA Filter Leak Test (e) Cabinet Leak Test (f) Electrical Leakage and Ground Circuit Resistance and Polarity Tests (g) Lighting Intensity Test (h) Vibration Test (i) Noise Level Test (j) UV Lamp Test _____________________________________________________________________________________________________________________________________ EHS-M-30 Issue Date: 11/05/07 Reviewed: MAR Page 5 of 7 Destroy Previous Revisions USC BIOLOGICAL SAFETY CABINET PROGRAM PAGE 6 of 7 (3) Gas Decontamination (a) BSCs that have been used for work involving infectious materials must be decontaminated before HEPA filters are changed or internal repair work is done. (b) Before a BSC is relocated, a risk assessment which considers the agents manipulated within the BSC must be done to determine the need for decontamination. (c) The most common decontamination method uses formaldehyde gas, although more recently hydrogen peroxide vapor has been used successfully. (d) Lab personnel should contact Environmental Health and Safety for guidance when determining the need for gas decontamination. 6. PROGRAM ADMINISTRATION (1) Coordination of certification. Primary responsibility for the coordination of annual BSC certifications is held by the following: (a) USC-Columbia – USC Environmental Health and Safety (b) USC School of Medicine, including Medical Park buildings – USC School of Medicine Safety Office (2) Funding: (a) USC Environmental Health and Safety provides funding for annual certification of BSCs in laboratories at the USC-Columbia campus. (b) The School of Medicine Health and Safety Office provides funding for annual certification of BSCs at the USC School of Medicine and Medical Park buildings. (3) BSC Inventory: (a) USC Environmental Health and Safety maintains a database inventory of BSCs for USC-Columbia and the School of Medicine. Individual hoods are identified by a unique tracking number. Each hoods class and type, certification date and location are included in the database. Certification dates are reported to EHS so the database can be updated. (b) All new BSC installations will be reported to EHS for addition to the database. (c) EHS will share this database with the designated certification vendor to ensure all BSCs are certified annually and certification records are accurately maintained. _____________________________________________________________________________________________________________________________________ EHS-M-30 Issue Date: 11/05/07 Reviewed: MAR Page 6 of 7 Destroy Previous Revisions USC BIOLOGICAL SAFETY CABINET PROGRAM PAGE 7 of 7 7. RESPONSIBILITIES 1) Facility Services Maintenance – Research Group School of Medicine Safety Office a) Coordinates annual certification for BSCs at the USC School of Medicine and Medical Park buildings. b) Reports to EHS any BSC maintenance/repairs, post-repair certifications, and BSC relocations or new installations. 2) Environmental Health and Safety a) Maintains an updated database of all BSCs in laboratories at each USC campus. b) Coordinates with the designated certification vendor to ensure all BSCs in the database are certified annually. 3) Principal Investigators/BSC Users a) Ensure the implementation of appropriate work practices when using a BSC, consistent with this program and biological safety training. b) Promptly report any problems with BSCs to the appropriate maintenance personnel so that necessary maintenance or repairs can be performed. c) Report the relocation or new installation of BSCs to Environmental Health and Safety so that each cabinet can be certified prior to use. This will also ensure the BSC certification database accurately reflects the location of each cabinet requiring annual certification. _____________________________________________________________________________________________________________________________________ EHS-M-30 Issue Date: 11/05/07 Reviewed: MAR Page 7 of 7 Destroy Previous Revisions