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    4 views12 pages

    Sanitec Air Emissions Study

    Uploaded by

    Heri Permana
    ..

    Copyright:

    © All Rights Reserved
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    ANNEXURE I Sanitec., Inc. Microwave Medical Waste Treatment System Air Emissions Testing & Evaluation SANITEC MICROWAVE DISINFECTION SYSTEM AIR EMISSIONS TESTING AND EVALUATION introduction The use of a variety of nen-burn medical waste treatment technologies has given rise to many questions and concerns regarding possible harmful air emissions. High temperature steam sterilization, chemical treatment, pyrolysis, and other devices have the potential to cause concerns about adverse environmental and public health effects. In keeping with our leading record of accomplishments, Sanitec has taken the initiative to be the first alternative nen-burn medical waste weatment technology to undergo stringent testing and evaluation for possible harmful air emissions. In order to demonstrate the effectiveness and safety of the Sanitec system, Sanitec submitted to a testing program developed by the State of New Jersey involving six (6) operating Sanitec units at various locations. This report discusses the standards and recommendations used to evaluate air filtration systems, emissions limits suitable for worker safety and actual test data on the Sanitec system's ability to meet or exceed these standards. Methodologies for Evalu: ‘The Sanitec unit HEP; jon Syster 23 a High Efficiency Particulate Air (HEPA) filter to control the possible release of bioaerosols generated during the shredding process of medical waste. Several methods have been used to evaluate the efficiency of this filtration system. ‘The methods used to evaluate a HEPA filtration system are based upon the design of the system. When used in Biological Safety Cabinets (BSC), the standard method for testing involves a quantitative leakage end filter performance test (Le., the diocal phthalate [DOP] penetration test). The DOP test invelves the introduction of a ga132) ' SANITEC MICROWAVE DISINFECTION SYSTEM Al INS TESTING AND standardized quantity of particles upstream of the filter. A photometer is used down stream of the filter to determine the percent (%) penetration through the fier system. The National Sanitation Foundation (NSF) has guidelines for conducting these types of tests (NSF-49) on BSCs. In applications other than BSCs where HEPA filtration systems are used, the Institute of Environmental Sciences (IES) has recommended practices for testing HEPA filters. These recommended practices would apply to areas such as Isolation reams, portable filtration system and the Sanitec unit. The IES recommended practices includes the use ‘of a DOP test. A third method is to challenge a filtration system with @ known quantity of microorgenisms. The efficiency of the system is then determined using microbiological sampling and cuttunng metnods. Of these methods, microbiological testing is the most difficult. Several factors must be considered before undertaking testing. First is to select the most appropriate test(s) for any given situation. Second, one must know how, where, and what to sample. And finally, one must know how to interpret the tests correctly. An accurate analysis of the environment requires sufficient knowledge of the nature and extent of the health complaints, the characteristics of disease states that can be caused by biological contaminants, locatiens where contaminants reside, and an understanding of the limitations of the assays gats2 2 SANITEC MICROWAVE DISINFECTION SYSTEM AIR EMISSIONS TESTING AND EVALUATION In the United States, the Centers fer Disease Control (CDC) has guidelines fer emissions from BSCs and air from rooms having patients with contagious respiratory infections. As an example, in the recent “Guidelines for Preventing Transmission of Mycobacterium tuberculosis in Health Care Facilities, October 1984". the CDC recommends that air from isolation rooms should be discharged to the outside, without filtration. If that cannot be accomplished, a HEPA filter is required before recirculating the air back into the patient care area. HEPA filters are not necessary for air being discharged to the outside if the exhaust air cannot re-enter the ventilation system. Similar recommendations apply to BSCs. The CDC recommends discharging to outside air because of. the major role atmaspheric factors have in limiting the survival of organisms. Organism concentration will be reduced by ultraviolet light, temperature, oxygen, carbon monoxide, ozone, and water vapor. Filtering contaminated air before release to the outdoors assists in reducing the concentration of viable organisms The CDC also recommends the use of DOP tests on newly installed filters and every time they are changed. Filters should also be tested every six months in general use areas and in areas with systems that exhaust air likely to be contaminated with Mycobacterium tuberculosis. HEPA filters with @ 99.97% rating at 0.3 microns are recommended in these guidelines. This rating indicates the HEPA filter is able to filter 99.97% of particles >0.3 microns in size ‘A manometer or other pressure-sensing device should be installed in the filter system to pravide accurate and objective means of determining the need for filter replacement. gat32) 3 SANITEC MICROWAVE DISINFECTION SYSTEM AIR EMISSIONS TESTING AND EVALUATION Sanitec HEPA Filtration System Testing Sanitec has adopted several of the recommendations for testing of tne HEPA filtration system. This includes the DOP test to IES recommendations. Penetration of DOP cannot exceed 0.01%, All HEPA filtration systems are checked at Sanitec before shipment to ensure the initial installation and filter are working properly ‘The HEPA filters installed in Sanitec units are able to filter 99,9995% of particles >0.12 microns in size, These are technically more efficient than those typically installed in aSCs. Amanometer is also located on the HEPA filter cabinet to measure pressure differential that would indicate when a filter needs changing. A manometer reading exceeding 0.75 pascals indicates the HEPA filter should be changed, To extend the life of the HEPA filter, it is recommended the prefilter be changed on a regular basis (every 1 to 2 months). When the HEPA filter is changed, it is recommended that a DOP or particle counter test be conducted to ensure the filter has been properly installed. Microbiclogical testing of the HEPA tiltration system has also been conducted. The testing involved the introduction af @ known concentration of bacterial spores into the Sanitec unit, Microbiological air sampling equioment was placed down stream of the filter, This testing was conducted on several units in New Jersey. Table | is a synopsis of the data generated from those tests. gat32) ‘ SANITEG MICROWAVE DISINFECTION SYSTEM AIR EMISSIONS TESTING AND EVALUATION Data from the studies demonstrate the high efficiency of the filtration systems, The methodology used to test the unit was a draft protocol from the US. EPA The sensitivity and specificity of the test remain to be determined. However, DOP tests also conducted after the microbiological tests indicate the filtration systems are well within the limits of IES recommendations. Two types of tests have baen conducted on the units (micrebiclegical and DOP). The microbiological tests provide additional ‘evidence that the DOP test is en appropriate methed for evaluating the Sanitec HEPA filtration system. Volatile Organic Compounds Emissions Volatile organic materials must be managed, packaged and separated as chemical hazardaus waste and disposed of in an appropriate manner. These materials should not be present in the infectious waste stream for processing in the Sanitec system. Hawever, it is known that, from a practical viewpoint, small quantities can occasionally enter the waste stream. Therefore, it must be determined if the presence of toxic/organic compounds in medical waste creates a dangerous health risk. First, it should be understood that the Sanitec process does not use chemicals in the process or create organic compounds. These materials can only enter the system through improper waste handling/segregation practices, ‘There are several organizations that deal with concerns regarding health effects due to exposure to toxic volatile organic compounds. In the U.S., the Federal government's occupational health and safety organization, commonly known as OSHA, has established permissible exposure limits (PEL) for toxic and hazardaus substances qdis2) 5 SANITEC MICROWAVE DISINFECTION SYSTEM AIR EMISSIONS TESTING AND EVALUATION found in industry. The U.S. Dept. of Labor and the National institute for Occupational Safety and Health (NIOSH) have provided technical advice to OSHA in the establishment of PEL values for worker exposure. These figures ere presented in Column 1 of the enclosed Table 2. In addition, NIOSH recommended exposure limits are noted in the second column, These limits are based on on-going research of the health effects of chemical exposure. The American Conference of Government Industrial Hygienists (ACGIH) Threshold Limit Values (TLV) ere also contained in the third column. ‘As mentioned earlier, these standards are applied to any industry where a worker can be exposed to toxic organic compounds. Presumably, if an application complies with these guidelines and regulations, there will be no potential of adverse health effects due to worker exposure, The enclosed Table 3 shows the organic emissions results of six Sanitec installations in New Jersey. It should be noted that these results were achieved without the benefit of an activated carbon filter which is a standard component for the Senitec system. In all cases, the results were far below the limits established for a safe working environment, Following Table 3 is a copy of an actual evaluation report performed by an Independent testing firm. This report describes the detail test procedures used at all ix installations. Conclusions Based upon the information presented, the Sanitec Microwave Disinfection system has been tested and demonstrated to operate very efficiently and does not emit any harmful air emissions. The tests results for microbiological emissions on the Sanitec system proved performance levels to be far safer than the guidelines gai32) 6 SANITEC MIGROWAVE DISINFECTION SYSTEM AIR EMISSIONS: ING AND EVALUATION established by national organizations such as CDC, NSF and IES. In addition Sanitec's performance concerning VOC emissions were substantially below the limits: established for worker safety by OSHA, NIOSH and CGIH. The consistency of Sanitec's performance, demonstrated at six different locations, concludes that this degree of testing is unnecessary to monitor routine performances. The cost effective and technically sound method of DOP testing should be considered as en appropriate test method to verify the perfermance of any Sanitec installation. gans2) 7 SANITEG MICROWAVE DISINFECTION SYSTEM AIR EMISSIONS TESTING AND EVALUATION TABLE 1 Pathogen Emission Summary from Sanitec Units at New Jersey Hospitals Tospital Day Colonies, Spores! a : (est Date) of Test Reported” DScr* ese ream? Weel Jersey 1 23783 <15 ‘OTs 194 2 4373.6 <13 a 3

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