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2 Page 1 of 5 TITLE: STANDARD OPERATING PROCEDURE FOR BIOLOGICAL SAFETY CABINET CLASS I and CLASS II OPERATION AND MAINTENANCE CHAPTER: SOP #: 3-Equipment SF Issue Date: Effective Date: SUPERSEDES SOP #: N/A AUTHORED BY: APPROVAL: QA APPROVAL: Indiana CTSI SSF Staff Indiana CTSI SSF, Director Quality Compliance Specialist DATE: DATE: DATE: 1. REVISION 1.1. Significant changes incorporated in this version include: Title revised to include Class II cabinets. Updated Sections 2 and 4 to reflect this addition Updated section 5 to include bleach, paper towels, and to clarify application mechanism/preparation requirements, as applicable Procedure in step revised to reflect generalized procedure for checking for the presence of air flow with regards to both Class I and Class II BSCs Added step to mandate documentation of air flow presence before each use. Updated Appendix A accordingly Added the use of 10% bleach as part of the cleaning directives in all applicable sections of the SOP and specified the duration of the required contact time in steps and Removed steps and to eliminate redundancy as these directives are covered in step Revised directives for monthly deep cleaning of BSC in Section 6.3 to generalize procedure for all BSCs Eliminated the weekly requirement of checking for the presence of air flow in Section since this is now checked and documented prior to each use. Updated Appendix A accordingly Removed decontamination requirement before service throughout Sections 6.4 and 6.5 because this must be done by a qualified vendor Updated numerous section references as a result of SOP updates Removed telephone number references documented throughout the SOP for Lewis Testing Services, Inc. since it is documented in Section Added reference to a Class II BCS operator s manual and to Lewis Testing Services, Inc. in Section 7.

3 Page 2 of Significantly revised Appendix A to include all SOP directive updates, to include additional spaces for documenting non-routine maintenance, and for ease of use. Updated name of Appendix A to reflect new usage directives. 2. PURPOSE 2.1. This Standard Operating Procedure (SOP) defines the procedures used in the Indiana CTSI Specimen Storage Facility (SSF) to maintain and operate Class I and Class II biological safety cabinets in a manner which complies with all appropriate regulatory and protocol specific requirements; as well as to ensure that all personnel are consistently using biological safety cabinet. 3. PRINCIPLE 3.1. A biosafety cabinet (BSC) - also called a biological safety cabinet or microbiological safety cabinet - is an enclosed, ventilated laboratory workspace for safely working with materials contaminated with (or potentially contaminated with) pathogens requiring a defined biosafety level. There are three classes of BSCs that have been developed to meet various research and clinical needs. A Class I BSC has a HEPA filter in the exhaust system to protect the environment, but unfiltered room air is drawn in through the work opening. Therefore, these cabinets do not provide a suitable environment for performing laboratory work that requires aseptic processing. Class II BSCs utilize a laminar air flow. Both exhaust and supply airs are HEPA filtered, thus providing personnel, environment, and product protection. Class III BSCs are focused on maximizing personnel safety. They are designed to work with highly infectious microbial agents and for the conduct of hazardous operations. These types of cabinets utilize a gas-tight enclosure with a non-opening view window. Long, heavy-duty rubber gloves are attached in a gas-tight manner to ports in the cabinet to allow direct manipulation of the materials isolated inside. 4. SCOPE 4.1. The SOP applies to all SSF staff and is intended to provide the basic procedure for operating and maintaining Class I and Class II biological safety cabinets. 5. MATERIALS % Ethanol (in a spray bottle) % bleach, prepared fresh daily (in a spray bottle) 5.3. General soap and water solution ( in a spray bottle) 5.4. paper towels 6. PROCEDURE 6.1. OPERATION Start up the cabinet by turning on the cabinet lights and blower at least 15 minutes prior to beginning work in the hood Ensure the UV light is turned off before use Ensure that the air intake and exhaust portals are not obstructed Check the air flow (blower) gauge to determine if the blower is operating and airflow is present If the blower gauge indicates no airflow exists (value of less than 0.1) DO NOT use the BSC. This could be indicative of blower malfunction or HEPA filter wear/damage. Contact Lewis Testing Services, Inc. or another approved BSC repair and certification specialist. Alert SSF management. Refer to Section for non-routine maintenance.

4 Page 3 of Document date of use and air flow gauge on Appendix A Don lab coat and gloves for work in cabinet Spray and wipe down the interior surfaces with 10% bleach Spray and wipe down the interior surfaces with 70% alcohol solution Place any necessary materials for processing into the cabinet Materials should be placed as far back into the cabinet as practical Do not overload the cabinet, which could cause a disruption in air flow After placing materials in cabinet, allow 2-3 minutes before beginning work for air flow to stabilize Minimize the amount of turbulence within the BSC by using deliberate and slow movements during processing The middle third of the interior work surface is the ideal area to perform processing When processing is completed, remove all materials that should not remain in the cabinet and decontaminate the surfaces by spraying with 10% bleach (allow solution to maintain contact with surfaces for 10 minutes before wiping dry), followed by spraying with 70% alcohol Shut down the cabinet by turning the lights and blower off Additionally, the UV light can be turned on as a decontamination step (optional) for a period of at least 30 minutes FUNCTION VERIFICATION There is no defined function verification procedure for biological safety cabinets other than what is described in step CLEANING Cleaning prior to and after use is described in section Monthly, deep cleaning of all internal/external surfaces (with the exception of the UV lamp) is performed using soapy water from a spray bottle followed by spraying with 10% bleach (allow solution to maintain contact with surfaces for 10 minutes before wiping dry) and spraying with 70% alcohol DO NOT remove any panels or surfaces inside the BSC, as this could disrupt the critical components to the equipment. A cleaning of the four internal surfaces is sufficient Monthly, wipe off dust and debris from the UV lamp Document monthly cleaning on Appendix A MAINTENANCE Routine Preventative maintenance (PM) is performed annually at minimum. Contact Lewis Testing Services, Inc. or another approved BSC repair and certification specialist for service The BSC must be cleaned prior to any service performed by an outside vendor. See Section 6.3 for cleaning directives. Document cleaning for vendor service on Appendix A.

5 Page 4 of Attach PM and recertification documentation (see Section 6.5 below) to Appendix A. Document issues found during the PM and the resolutions Non-Routine If the BSC is not functioning properly, notify SSF management. DO NOT use the BSC. Contact Lewis Testing Services, Inc. or another approved BSC repair and certification specialist for service. Initiate an Out of Specification form per SOP 1-10 (Out of Specification Condition and Notification Management) The BSC must be cleaned prior to any service performed by an outside vendor. See Section 6.3 for cleaning directives. Document cleaning for vendor service on Appendix A Attach repair and recertification documentation (see Section 6.5 below) to Appendix A. Document issues found and the resolutions BSC Operation and Maintenance records are reviewed annually RECERTIFICATION Cabinet recertification is done annually at minimum at the time of the routine preventative maintenance. Recertification is REQUIRED when non-routine maintenance is warranted and when the BSC is physically moved. Contact Lewis Testing Services, Inc. or another approved BSC repair and certification specialist for service Recertification shall include, but may not be limited to: a HEPA filter leak test, a face or inflow velocity check, a smoke airflow patterns evaluation, and electrical field tests. The technician may also evaluate UV and standard lighting intensities, noise level, vibrations, and monitors and alarms The BSC must be cleaned prior to service performed by an outside vendor. See Section 6.3 for cleaning directives. Document cleaning for vendor service on Appendix A Cabinet recertification documentation is attached to Appendix A. 7. REFERENCES 7.1. Purifier HEPA Filtered Enclosures & Purifier Class I Filtered Enclosures User s Manual (located in the SSF Operation s Office in the equipment binder) Baker SterilGARD Class II, Type A2 Biological Safety Cabinet Operator s Manual (located in the SSF Operation s Office in the equipment binder) Lewis Testing Services, Inc: P.O. Box Indianapolis, IN Ph: U.S. Centers for Disease Control and Prevention website ( U.S. Environmental Protection Agency ( 8. DOCUMENTATION 8.1. Maintenance logs and annual certification documentation are submitted for review by SSF Management and maintained per SF-1-6 Controlled Document Management SOP Deviations are managed per the SF-1-9 Deviation Management SOP OOS Results are documented as defined in SF-1-10 SOP for OOS Response and Management.

6 Page 5 of 5 9. APPENDICES 9.1. The current version of each of the following appendices is used to guide and/or implement this SOP: APPENDIX A Biological Safety Cabinet Usage and Maintenance Log (1 Page)

7 Appendix A Page 1 of 1 Biological Safety Cabinet Usage and Maintenance Log BSC Serial Number Location: Year: Page of Usage Record: NOTE: must be 0.1 or greater. (Attach additional pages if necessary) CLEANING AND MAINTENANCE Monthly Cleaning of External/Internal Surfaces: Tech Initials/Date Annual PM and Recertification Non-Routine Maintenance (if applicable) Non-Routine Maintenance (if applicable) Non-Routine Maintenance (if applicable) Comments: Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec BSC cleaned before service? (Yes/No) Date services were performed: Description of Documentation Attached (Non-Routine Maintenance must include recertification) Tech Initials/Date Reviewed By: SOP SF-3-5 SOP for Biological Safety Cabinet Operation and Maintenance Version 02