Exposure Assessment of Four Pharmaceutical Powders Based on Dustiness and Evaluation of Damaged HEPA Filters

REFERENCES

• Boundy , M. , Leith , D. and Polton , T. 2006 . Method to evaluate the dustiness of pharmaceutical powders . Ann. Occup. Hyg. , 50 ( 5 ) : 453 – 458 .
   PubMed Web of Science ®Google Scholar
• Hamelmann , F. and Schmidt , E. 2005 . Methods for dustiness of industrial powders . China Particuology , 03 ( 01n02 ) : 90 – 93 .
   Google Scholar
• British Standards Institute and British Standards Institution . 2006 . Workplace Atmospheres: Measurement of the Dustiness of Bulk Materials - Requirements and Reference Test Methods. , London : British Standards Institution .
   Google Scholar
• Ibaseta , N. and Biscans , B. 2007 . Ultrafine aerosol emission from the free fall of TiO2 and SiO2 nanopowders . Kona-Powder and Particle , 25 : 190 – 204 .
   Web of Science ®Google Scholar
• Dahmann , D. and Monz , C. 2011 . Determination of dustiness of nanostructured materials . Gefahrstoffe Reinhaltung der Luft , 71 ( 11–12 ) : 481 – 487 .
   Web of Science ®Google Scholar
• Jensen , K. A. , Koponen , I. K. , Clausen , P. A. and Schneider , T. 2009 . Dustiness behaviour of loose and compacted bentonite and organoclay powders: What is the difference in exposure risk? . J. Nanoparticle Res. , 11 ( 1 ) : 133 – 146 .
   Web of Science ®Google Scholar
• O’Shaughnessy , P. T. , Kang , M. and Ellickson , D. 2012 . A novel device for measuring respirable dustiness using low-mass powder samples . J. Occup. Environ. Hyg. , 9 ( 3 ) : 129 – 139 .
   PubMed Web of Science ®Google Scholar
• Pensis , I. , Mareels , J. , Dahmann , D. and Mark , D. 2010 . Comparative Evaluation of the Dustiness of Industrial Minerals According to European Standard EN 15051 [Standard], 2006 . Ann. Occup. Hyg. , 54 ( 2 ) : 204 – 216 .
   PubMed Web of Science ®Google Scholar
• Schneider , T. and Jensen , K. A. 2008 . Combined single-drop and rotating drum dustiness test of fine to nanosize powders using a small drum . Ann. Occup. Hyg. , 52 ( 1 ) : 23 – 34 .
   PubMed Web of Science ®Google Scholar
• Tsai , C. J. , Wu , H. C. Leu , L. M. 2009 . Dustiness test of nanopowders using a standard rotating drum with a modified sampling train . J. Nanoparticle Res. , 11 ( 1 ) : 121 – 131 .
   Web of Science ®Google Scholar
• Jensen , K. A. , Saber , A. T. , Koponen , I. K. , Kristensen , H. V. and Wallin. Nanosafer , H. A flexible web-based control-banding tool for precautionary risk evaluating of dust exposure to manufactured nanomaterials in the work-place .
   Google Scholar
• Paik , S. Y. , Zalk , D. M. and Swuste , P. 2008 . Application of a pilot control banding tool for risk level assessment and control of nanoparticle exposures . Ann. Occup. Hyg. , 52 ( 6 ) : 419 – 428 .
   PubMed Web of Science ®Google Scholar
• Tielemans , E. , Noy , D. Schinkel , J. 2008 . Stoffenmanager Exposure Model: Development of a quantitative algorithm . Ann. Occup. Hyg. , 52 ( 6 ) : 443 – 454 .
   PubMed Web of Science ®Google Scholar
• Van Duuren-Stuurman , B. , Vink , S.R. Verbist , K.J.M. 2012 . Stoffenmanager nano version 1.0: A web-based tool for risk prioritization of airborne manufactured nano objects . Ann. Occup. Hyg. , 56 ( 5 ) : 525 – 541 .
   PubMed Web of Science ®Google Scholar
• Evans , D. E. , Turkevich , L. A. , Roettgers , C. T. , Deye , G. J. and Baron , P. A. 2013 . Dustiness of fine and nanoscale powders . Ann. Occup. Hyg. , 57 ( 2 ) : 261 – 277 .
   PubMed Web of Science ®Google Scholar
• Cherrie , J. W. , Gillies , A. T. Sleeuwenhoek , A. 2009 . Modelling exposure to pharmaceutical agents . J. Phys. Conf. Ser. , 151 ( 012063 )
   Google Scholar
• Mc Donnell , P. E. , Cherrie , J. W. , Sleeuwenhoek , A. , Gilles , A. and Coggins , M. A. 2011 . Refinement and validation of an exposure model for the pharmaceutical industry . J. Environ. Monitor. , 13 ( 3 ) : 641 – 648 .
   PubMed Web of Science ®Google Scholar
• Schneider , T. , Brouwer , D.H. and Koponen , I.K. 2011 . Conceptual model for assessment of inhalation exposure to manufactured nanoparticles . J. Exposure Sci. Environ. Epidemiol. , 21 ( 5 ) : 450 – 463 .
   PubMed Web of Science ®Google Scholar
• Binks , S. P. 2003 . Occupational toxicology and the control of exposure to pharmaceutical agents at work . Occup. Med.-Oxford , 53 ( 6 ) : 363 – 370 .
   PubMed Web of Science ®Google Scholar
• Larsen , A. I. , Johnsen , C. R. , Frickmann , J. and Mikkelsen , S. 2007 . Incidence of respiratory sensitisation and allergy to enzymes among employees in an enzyme producing plant and the relation to exposure and host factors . Occup. Environ. Med. , 64 ( 11 ) : 763 – 768 .
   PubMed Web of Science ®Google Scholar
• Michaels , D. and Monforton , C. 2005 . Scientific evidence in the regulatory system: Manufacturing uncertainty and the demise of the formal regulatory system . J. Law & Policy , 13 : 17 – 41 .
   Google Scholar
• Watrous , R. M. 1947 . Health hazards of the pharmaceutical industry . Br. J. Indus. Med. , 4 ( 2 ) : 111 – 125 .
   PubMedGoogle Scholar
• Wollowitz , S. 2010 . Managing high-potency active pharmaceutical ingredients-A drug sponsor's guide . Drug Develop. Res. , 71 ( 7 ) : 420 – 428 .
   Web of Science ®Google Scholar
• Touger-Decker , R. and van Loveren , C. 2003 . Sugars and dental caries . Amer. J. Clin. Nutr. , 78 ( 4 ) : 881S – 892S .
   PubMed Web of Science ®Google Scholar
• Johnsen , C. R. , Sorensen , T. B. Larsen , A. I. 1997 . Allergy risk in an enzyme producing plant: A retrospective follow up study . Occup. Environ. Med. , 54 ( 9 ) : 671 – 675 .
   PubMed Web of Science ®Google Scholar
• Vanhanen , M. , Tuomi , T. Tiikkainer , U. 2001 . Sensitisation to enzymes in the animal feed industry . Occup. Environ. Med. , 58 ( 2 ) : 119 – 123 .
   PubMed Web of Science ®Google Scholar
• Gorski , P. and Ulinski , S. 1996 . Effect of occupational exposure to opiates on the respiratory system . Intern. J. Occup. Med. Environ. Health , 9 ( 3 ) : 245 – 253 .
   PubMedGoogle Scholar
• Heron , R. J.L. and Pickering , F. C. 2003 . Health effects of exposure to active pharmaceutical ingredients (APIs) . Occup. Med.-Oxford , 53 ( 6 ) : 357 – 362 .
   PubMed Web of Science ®Google Scholar
• Hubbs , A. F. , Mercer , R. R. Benkovic , S. A. 2011 . Nanotoxicology-A pathologist's perspective . Toxicologic Pathol. , 39 ( 2 ) : 301 – 324 .
   PubMed Web of Science ®Google Scholar
• Murashov , V. 2009 . Occupational exposure to nanomedical applications . Wiley Interdisciplinary Reviews-Nanomed. Nanobiotech. , 1 ( 2 ) : 203 – 213 .
   PubMed Web of Science ®Google Scholar
• Schneider , T. and Jensen , K. 2009 . Relevance of aerosol dynamics and dustiness for personal exposure to manufactured nanoparticles . J. Nanoparticle Res. ,
   Web of Science ®Google Scholar
• Golanski , L. , Guiot , A. , Rouillon , F. , Pocachard , J. and Tardif , F. 2009 . Experimental evaluation of personal protection devices against graphite nanoaerosols: fibrous filter media, masks, protective clothing, and gloves . Human Experiment. Toxicol. , 28 ( 6–7 ) : 353 – 359 .
   PubMed Web of Science ®Google Scholar
• Rengasamy , A. , Zhuang , Z. P. and BerryAnn , M. S. 2004 . Respiratory protection against bioaerosols: Literature review and research needs . Am. J. Infect. Control , 32 ( 6 ) : 345 – 354 .
   PubMed Web of Science ®Google Scholar
• Rengasamy , S. and Eimer , B. C. 2012 . Nanoparticle penetration through filter media and leakage through face seal interface of N95 filtering facepiece respirators . Ann. Occup. Hyg. , 56 ( 5 ) : 568 – 580 .
   PubMed Web of Science ®Google Scholar
• Tsai , C. S.J. , Echevarria-Vegar , M. E. Sotiriou , G. A. 2012 . Evaluation of environmental filtration control of engineered nanoparticles using the Harvard Versatile Engineered Nanomaterial Generation System (VENGES) . J. Nanopart. Res. , 14 ( 5 ) : 812
   PubMed Web of Science ®Google Scholar
• Dubey , S. C. , Murughar , H. V. , Kaushik , R. K. and Kulkarni , D. D. 2009 . The efficiency of HEPA filters in the air-handling system of a bio-containment laboratory in India . Appl. Biosaf. , 14 ( 3 ) : 121 – 126 .
   Google Scholar
• First , M. W. 1996 . Aging of HEPA filters in service and storage . J. Am. Biological Saf. Assoc. , 1 ( 1 ) : 52 – 62 .
   Google Scholar
• Mouret , G. , Thomas , D. , Chazelet , S. , Appert-Collin , J. C. and Bemer , D. 2009 . Penetration of nanoparticles through fibrous filters perforated with defined pinholes . J. Aerosol Sci. , 40 ( 9 ) : 762 – 775 .
   Web of Science ®Google Scholar
• Brochot , C. , Michielsen , N. , Chazelet , S. and Thomas , D. 2012 . Measurement of protection factor of respiratory protective devices toward nanoparticles . J. Occup. Hyg. , 56 ( 5 ) : 595 – 605 .
   PubMed Web of Science ®Google Scholar
• Boskovic , L. , Agranovski , I. E. , Altman , I. S. and Braddock , R. D. 2008 . Filter efficiency as a function of nanoparticle velocity and shape . J. Aerosol Sci. , 39 ( 7 ) : 635 – 644 .
   Web of Science ®Google Scholar
• Dai , Y. T. , Juang , Y. J. , Wu , Y. Y. , Breysse , P. N. and Hsu , D. J. 2006 . In vivo measurements of inhalability of ultralarge aerosol particles in calm air by humans . J. Aerosol Sci. , 37 ( 8 ) : 967 – 973 .
   Web of Science ®Google Scholar
• 2003 . Code of Nuclear Air and Gas Treatment ASME AG-1, Article FC-4110 (b), New York: American Society of Mechanical Engineers
   Google Scholar
• 2013 . Code of Nuclear Air and Gas Treatment ASME AG-2, Article FC-5120, New York: American Society of Mechanical Engineers
   Google Scholar
• Comite Europeen de Normalisation (CEN) . 2009 . B. B. EN1822-1:2009 High Efficiency Air Filters (EPA, HEPA and ULPA). Part 1: Classification, Performance, Testing, and Marking , CEN .
   Google Scholar
• Cherrie , J. W. , MacCalman , L. and Fransman , W. 2011 . Revisiting the effect of room size and general ventilation on the relationship between near- and far-field air concentrations . Ann. Occup. Hyg. , 55 ( 9 ) : 1006 – 1015 .
   PubMed Web of Science ®Google Scholar
• Cherrie , J. W. and Schneider , T. 1999 . Validation of a new method for structured subjective assessment of past concentrations . Ann. Occup. Hyg. , 43 ( 4 ) : 235 – 245 .
   Web of Science ®Google Scholar
• Makela , J. M. , Koponen , I. K. , Aalto , P. and Kulmala , M. 2000 . One-year data of submicron size mods of tropospheric background aerosol in southern Finland . J. Aerosol Sci. , 31 ( 5 ) : 595 – 611 .
   Web of Science ®Google Scholar
• Clausen , P. A. , Jacobsen , N. R. and Jensen , K.A. 2010 . NANOPLAST: Nano-technological materials and products in the plastics industry: Exposure assessment and toxicological properties . Mod. Polymeric Mat. Environ. Applic. , 4 ( 2 ) : 53 – 60 .
   Google Scholar
• Saber , A. T. , Jensen , K. A. and Hougaard , K.A. 2010 . NANOKEM: Nanoparticles in the paint and lacquer industry. Exposure and toxic properties . Mod. Polymeric Mat. Environ. Applic. , 4 ( 2 ) : 111 – 120 .
   Google Scholar