1 NSF/ANSI 49 - 2010. Updates Copyright 2011 Micro-Clean, Inc. All Rights Reserved Copyright NSF 2010. Disclaimer Micro-Clean, Inc. does not represent, endorse, or recommend any BSC or filtration device manufacturer, or type of device over another. Any pictures, materials or descriptions presented here are for educational purposes only. 1. Objectives Understand the latest NSF/ANSI Std 49. changes on how they impact current BSC installations. Many older BSCs may not meet the current expectations of NSF. Customers should routinely evaluate their safety and equipment processes as part of safety committees with key departments represented BSC Types A1 / A2. have HEPA/ULPA filtered downflow air that is a portion of the mixed downflow and inflow air from a common plenum ( , a plenum from which a portion of the air is exhausted from the cabinet and the remainder supplied to the work area).
2 May exhaust HEPA/ULPA filtered air back into the laboratory or to the environment through an external exhaust system connected to the cabinet with a canopy connection; and Type A1 cabinets are not suitable for work with volatile toxic chemicals and tracer amount of volatile radionuclides 2. BSC Type B1. have HEPA/ULPA filtered downflow air composed largely of uncontaminated recirculated inflow air;. exhaust most of the contaminated downflow air to an external exhaust system through a dedicated duct connected to cabinet with a direct connection and exhausted to the atmosphere after passing through a HEPA/ULPA filter; and BSC Type B2. have HEPA/ULPA filtered downflow air drawn from the laboratory or the outside air ( , downflow air is not recirculated from the cabinet exhaust air).
3 Exhaust all inflow and downflow air to the atmosphere through an external exhaust system connected to cabinet with a direct connection after filtration through a HEPA/ULPA filter without recirculation in the cabinet or return to the laboratory; and 3. Other new definitions Canopy connection Direct connection Exhaust requirements Canopy connection required for externally vented A1 or A2 BSC ( ). Direct connection required for externally vented B1 or B2 BSC ( ). 4. Duct and Plenum design All biologically contaminated ducts and plenums in Types A1, A2, B1, and A2. cabinets shall be maintained under negative pressure or enclosed within a negative pressure zone. ( ). B2 directly exhausted (nonrecirculated). negative pressure zone was dropped A1 / A2 Exhaust Alarms Any Type A1 or A2 cabinet when canopy connected shall have an audible and visual alarm to indicate notifying the user of a potential loss in canopy containment ( ).
4 5. Updated drawings Copyright NSF 2010. Resistance to overturning Conforms to requirements of UL 61010-1. 6. Electrical Safety The cabinet shall be tested by a National Recognized Testing Laboratory (NRTL) for compliance to the requirements of the current edition of any national standard that is based on IEC 61010-1. Compliance is demonstrated by cabinet listing, UL, CSA, or IECEE CB. Scheme certificate. Annex A - Filter Leak Test The manufacturer shall determine the aerosol introduction point that provides the most uniform distribution (reference IEST-RP-CC-03422). The location of the aerosol introduction point shall be clearly described or indicated in a manner readily available to the certifier. The location should be described either on the cabinet data plate or with the electrical schematic if the schematic is affixed to the cabinet.
5 (NSF 49 - 2009, ). 7. Annex G parts to Annex E. BSC Selection, Installation, Life Span and Decommissioning section was moved from Annex G (Decontamination) to Annex E, now this title renames Annex E with this new information. Formerly Recommendations for Installation . Moved from Annex G to E. Consultation Prior to BSC Purchase Risk Assessment Procedure Selection of a BSC cabinet Prior to the Purchase [ Location section from old Annex E. ended up in here]. Inspection Moving a Permanently Installed Biosafety Cabinet Lifespan of BSCs Decommissioning process 8. Copyright NSF 2010. Risk Assessment Risk Management Assessment Table was reworked Biosafety Cabinet Selection Configuration drawings added Deciding class and type now determined by a new 5th question What needs to be protected?
6 What are all of the different types of work to be done in the cabinet? What types and quantities of chemical vapors will be generated in the BSC? If the unit requires an exhaust system, is there an appropriate location for the cabinet and its ductwork? NEW QUESTION: If the volume of air moved by the BSC. exhaust system is reduced, or eliminated, due to a malfunction, what is its effect on BSC performance, and what is preferred by the user? 9. Not acceptable hard ducted A's Question #4. (formerly) If the unit requires an exhaust system, is there an appropriate location for the cabinet and its ductwork? 2nd para: When connected to a hard-ducted exhaust system, however, the location of the cabinet becomes dependent on the location of the exhaust system.
7 The exhaust duct must be placed so it can penetrate ceilings and floors without disturbing other ventilation or plumbing systems. The exhaust system must also be designed to minimize excessive lengths and elbows. The exhaust system configurations of Type A and Type B BSCs are shown in figures E3 and E6, respectively. Hard ducting Type A cabinets is not acceptable and shall only be exhausted through a properly designed and fitted exhaust canopy. Electrical Outlets Work area outlet are limited in their amperage rating due to other components on the same power cord, blowers, lights, etc. Recommendation to add an external voltage regulator when wall outlet line voltage variations affect cabinet airflows. 10. Base Stands Have a maximum height specified by manufacturer to prevent BSC overturning.
8 This maximum should never be exceeded. Mobile Installations Proper cabinet operation should be confirmed by airflow smoke pattern at each site of use. If a cabinet is relocated to another facility, or subjected to excessive shock and/or vibration during moving, the BSC should be recertified to ensure it is functioning in a proper manner.. NuAire 11. the former Location . section in Annex E. Location of BSC. The cabinet should be located away from traffic patterns, doors, fans, ventilation registers, fume hoods, and any other air-handling device that could disrupt its airflow patterns. Clearances (NSF 2008 numbers in parentheses). BSCs not connected to an exhaust system should have at least 6 (3 ). clearance from any overhead obstruction when the cabinet is in its final operating position, to allow for testing of the Exhaust HEPA/ULPA filter.
9 (NSF 2008 required 12 above if using TA for airflow on exhaust HEPA. This is no longer mentioned. MCI submitted change request to NSF). Maintain 6 (12 , 3 absolute minimum) clearance on sides, 12 (12 , . absolute minimum) clearance behind unit, for service. [2010 dropped] modulated flow exhaust system It is recognized that there is interest in utilizing the increasingly sophisticated modulated flow exhaust ventilation systems where the exhaust from Type B1. or B2 cabinets, CFH, flexible exhaust hoses, and/or room exhausts are modulated based on use to optimize containment, maintain appropriate pressure differentials, and maximize energy savings by reducing overall exhaust volume. These systems are required to maintain a high level of control of many complex factors over a number of years.
10 Although the potential cost savings are great, the severity of the hazards contained by the biological safety cabinets requires the use of simpler and more reliable constant flow systems for the cabinet exhaust. If a modulated flow exhaust system is used, it is recommended that the operation of the cabinet exhaust be verified under a variety of conditions over time. Furthermore, the type of exhaust alarm must be assessed in the light of the type of sensors and controls used in the modulated flow system. 12. Annex F. Exhaust System Performance canopy connected Type A1 and A2 BSC Using a visual medium source positioned to demonstrate containment of BSC exhaust by the canopy, reduce the external exhaust until the alarm signals audibly. The alarm shall sound before visible canopy containment is lost.