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Research ArticleResearch

Quality Control Testing for Tracking Endotoxin-Producing Gram-Negative Bacteria during the Preparation of Polyvalent Snake Antivenom Immunoglobulin

Norhan S. Sheraba, Mohamed R. Diab, Aymen S. Yassin, Magdy A. Amin and Hamdallah H. Zedan
PDA Journal of Pharmaceutical Science and Technology July 2015, 69 (4) 499-510; DOI: https://doi.org/10.5731/pdajpst.2015.01058
Norhan S. Sheraba
1Vacsera, The Holding Company for Biological Products and Vaccines, Giza, Egypt;
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Mohamed R. Diab
1Vacsera, The Holding Company for Biological Products and Vaccines, Giza, Egypt;
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Aymen S. Yassin
2Department of Microbiology and Immunology, Faculty of Pharmacy, Cairo University, Cairo, Egypt
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  • For correspondence: aymen.yassin@pharma.cu.edu.eg
Magdy A. Amin
2Department of Microbiology and Immunology, Faculty of Pharmacy, Cairo University, Cairo, Egypt
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Hamdallah H. Zedan
2Department of Microbiology and Immunology, Faculty of Pharmacy, Cairo University, Cairo, Egypt
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References

  1. 1.↵
    1. Swaroop S.,
    2. Grabb B.
    Snakebite mortality in the world. Bull. World Health Organ. 1954, 10 (1), 35–76.
    OpenUrlPubMed
  2. 2.↵
    1. Acconci C.,
    2. Legallais C.,
    3. Vijayalakshmi M.,
    4. Bueno S. M.
    Depyrogenation of snake antivenom serum solutions by hollow fiber-based pseudobioaffinity filtration. J. Membr. Sci. 2000, 173 (2), 235–245.
    OpenUrl
  3. 3.↵
    1. Santos P. G.,
    2. Santos D. O.,
    3. Serodio L. R.,
    4. Marinho R. D. S.,
    5. Rodrigues C. R.,
    6. Cabral L. M.,
    7. de Pádula M.,
    8. de Sousa V. P.,
    9. Castro H. C.
    Antiophidian sera sterility control: topics in perspective. Brazilian Journal of Pharmaceutical Sciences 2009, 45 (3), 401–415.
    OpenUrl
  4. 4.↵
    British Pharmacopoeia; Her Majesty's Stationary Office: London, 2008; pp 3500–3501.
  5. 5.↵
    1. Bashar T.,
    2. Shurovi K. M.,
    3. Dilshad S.
    An improved in vitro pyrogen test to detect the presence of endotoxin containing bacteria using limulus amoebocyte lysate assay from pharmaceutical raw product. Stamford J. Pharm. Sci. 2008, 1 (1&2), 76–79.
    OpenUrl
  6. 6.↵
    1. Morey P. R.,
    2. Feeley J. C.,
    3. Otten J. A.
    1. Olenchock S. A.
    Endotoxins. In Biological Contaminants in Indoor Environments; Morey P. R., Feeley J. C., Otten J. A., Eds.; American Society for Testing and Materials: Philadelphia, 1990; pp 190–200.
  7. 7.↵
    1. Liesivuori J.,
    2. Kotimaa M.,
    3. Laitinen S.,
    4. Louhelainen K.,
    5. Ponni J.,
    6. Sarantila R.,
    7. Husman K.
    Airborne endotoxin concentrations in difference work conditions. Am. J. Ind. Med. 1994, 25 (1), 123–124.
    OpenUrlCrossRefPubMed
  8. 8.↵
    1. Laitinen S.,
    2. Nevalainen A.,
    3. Kotimaa M.,
    4. Liesivuori J.,
    5. Martikainen P. J.
    Relationship between bacterial counts and endotoxin concentrations in the air of wastewater treatment plants. Appl. Environ. Microbiol. 1992, 58 (11), 3774–3776.
    OpenUrlAbstract/FREE Full Text
  9. 9.↵
    World Health Organization (WHO). Guidelines for the Production, Control and Regulation of Snake Antivenom Immunoglobulins. Blood Products and Related Biologicals, WHO, 58th Meeting, Geneva, Switzerland, 2008.
  10. 10.↵
    1. Utescher C. L. A.,
    2. Franzolin M. R,
    3. Trabulsi L. R.,
    4. Gambale V.
    Microbiological monitoring of clean rooms in development of vaccines. Brazilian Journal of Microbiology 2007, 38 (4), 710–716.
    OpenUrl
  11. 11.↵
    1. Denyer S. P.,
    2. Baird R. M.
    Guide to Microbiological Control in Pharmaceuticals and Medical Devices, 2nd ed.; Denyer S. P., Baird R. M., Eds.; CRC Press: Boca Raton, FL, 2007.
  12. 12.↵
    1. Langer U.,
    2. Krämer I.
    GMP In hospital pharmacy: environmental monitoring of the CIVA preparation area. Eur. Hosp. Pharm. 2001, 7 (3), 97–107.
    OpenUrl
  13. 13.↵
    1. Vincent D. W.
    Validating, establishing, and maintaining a routine environmental monitoring program for cleanroom environments: Part É. J. Validation Technol. 2002, 8 (4), 352–374.
    OpenUrl
  14. 14.↵
    1. Cobo F.,
    2. Concha A.
    Environmental microbial contamination in a stem cell bank. Lett. Appl. Microbiol. 2007, 44 (4), 379–386.
    OpenUrlPubMed
  15. 15.↵
    1. Benson H. J.
    Microbiology Applications: Laboratory Manual in General Microbiology, 8th ed.; McGraw-Hill: Boston, MA, 2002.
  16. 16.↵
    United States Pharmacopeia 32-NF27. Chapter <71> Sterility Tests. In The United States Pharmacopeia 31st ed.—National Formulary 26th ed.; United States Pharmacopeia Convention, Inc.: Rockville, MD, 2009; pp 85–91.
  17. 17.↵
    1. Akers M. J.,
    2. Larrimore D. S.
    Parenteral Quality Control Sterility, Pyrogen, Particulate, and Package Integrity Testing, 3rd ed.; Marcel Dekker: New York, 2003.
  18. 18.↵
    1. Cooper J. F.,
    2. Hung J. C.
    Bacterial endotoxin test and sterility test for radiopharmaceuticals. University of New Mexico, Health Sciences Center, College of Pharmacy 2008, 14 (5), 30–35.
    OpenUrl
  19. 19.↵
    1. Fujita Y.,
    2. Tokunaga T.,
    3. Kataoka H.
    Saline and buffers minimize the action of interfering factors in the bacterial endotoxins test. Anal. Biochem. 2011, 409 (1), 46–53.
    OpenUrlPubMed
  20. 20.↵
    1. Dawson M. E.
    Interference with LAL test and how to address it. LAL Update 2005, 22 (3), 1–5, 2005.
    OpenUrl
  21. 21.↵
    1. Crawford S. Y,
    2. Narducci W. A,
    3. Augustine S. C.
    National survey of quality assurance activities for pharmacy-prepared sterile products in hospitals. Am. J. Hosp. Pharm. 1991, 48 (11), 2398–2413.
    OpenUrlAbstract
  22. 22.↵
    1. Szymanska J.
    Endotoxin level as a potential marker of concentration of Gram-negative bacteria in water effluent from dental units and in dental aerosols. Ann. Agric. Environ. Med. 2005, 12 (2), 229–32.
    OpenUrlPubMedWeb of Science
  23. 23.↵
    1. Coccia A. N.,
    2. Gucci P. M.,
    3. Lacchetti I.,
    4. Paradiso R.,
    5. Scaini F.
    Airborne microorganisms associated with waste management and recovery: biomonitoring methodologies. Environmental Issues of Health Concern 2010, 46 (3), 288–292.
    OpenUrl
  24. 24.↵
    1. Perdelli F.,
    2. Dallera M.,
    3. Cristina M. L.,
    4. Sartini M.,
    5. Ottria G.,
    6. Spagnolo A. M.,
    7. Orlando P.
    A new microbiological problem in intensive care units: environmental contamination by MRSA with reduced susceptibility to glycopeptides. J. Int. Hyg. Environ. Health 2008, 211 (1), 213–218.
    OpenUrl
  25. 25.↵
    European Commission. The Rules Governing Medicinal Products in the European Union. EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use. Vol 4. Annex 14: Manufacture of Medicinal Products Derived from Human Blood or Plasma. European Commission: Brussels, 2010.
  26. 26.↵
    1. Singh T. S.,
    2. Bello B.,
    3. Mabe O. D.,
    4. Renton K.,
    5. Jeebhay M. F.
    Workplace determinants of endotoxin exposure in dental healthcare facilities in South Africa. Ann. Occup. Hyg. 2010, 54 (3), 299–308.
    OpenUrlAbstract/FREE Full Text
  27. 27.↵
    1. Grisoli P.,
    2. Rodolfi M.,
    3. Villani S.,
    4. Grignani E.,
    5. Berri D. C. A.
    Assessment of airborne microorganism contamination in an industrial area characterized by an open composting facility and a wastewater treatment plant. Environ. Res. 2009, 109 (2), 135–142.
    OpenUrlPubMed
  28. 28.↵
    1. Krieg N. R.,
    2. Holt J. G.
    Bergey's Manual of Systematic Bacteriology; Krieg N. R., Holt J. G., Eds.; Williams & Wilkins: Baltimore, MD, 1984; Vol. 1.
  29. 29.↵
    1. Halls N.
    1. Halls N.
    Microbiological Environmental Monitoring. In Microbiological Contamination Control in Pharmaceutical Clean Rooms; Halls N., Ed.; CRC Press: Boca Raton, FL, 2004; pp 23–51.
  30. 30.↵
    1. Sheraba N. S.,
    2. Yassin A. S.,
    3. Amin M. A.
    High-throughput molecular identification of Staphylococcus spp. isolated from a clean room facility in an environmental monitoring program. BMC Research Notes 2010, 3(1), 278.
    OpenUrlPubMed
  31. 31.↵
    1. Clontz L.
    Microbial Limit and Bioburden Tests—Validation Approaches and Global Requirements, 2nd Ed.; CRC Press/Taylor & Francis Group: London, New York, 2009.
  32. 32.↵
    1. Evans T. M.,
    2. Schillinger J. E.,
    3. Stuart D. G.
    Rapid determination of bacteriological water quality by using limulus lysate. J. Appl. Environ. Microbiol. 1978, 35 (2), 376–382.
    OpenUrlAbstract/FREE Full Text
  33. 33.↵
    1. Rylander R.
    Endotoxins in the environment: a criteria document. Int. J. Occup. Environ. Health 1997, 3, S32–S36.
    OpenUrl
  34. 34.↵
    1. Stellman J. M.,
    2. Klitzman S.,
    3. Gordon G. C.,
    4. Snow B. R.
    Air quality and ergonomics in the office: survey results and methodology issues. Am. Ind. Hyg. Assoc. J. 1985, 46 (5), 286–293.
    OpenUrlPubMedWeb of Science
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PDA Journal of Pharmaceutical Science and Technology: 69 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 69, Issue 4
July/August 2015
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Quality Control Testing for Tracking Endotoxin-Producing Gram-Negative Bacteria during the Preparation of Polyvalent Snake Antivenom Immunoglobulin
Norhan S. Sheraba, Mohamed R. Diab, Aymen S. Yassin, Magdy A. Amin, Hamdallah H. Zedan
PDA Journal of Pharmaceutical Science and Technology Jul 2015, 69 (4) 499-510; DOI: 10.5731/pdajpst.2015.01058

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Quality Control Testing for Tracking Endotoxin-Producing Gram-Negative Bacteria during the Preparation of Polyvalent Snake Antivenom Immunoglobulin
Norhan S. Sheraba, Mohamed R. Diab, Aymen S. Yassin, Magdy A. Amin, Hamdallah H. Zedan
PDA Journal of Pharmaceutical Science and Technology Jul 2015, 69 (4) 499-510; DOI: 10.5731/pdajpst.2015.01058
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Keywords

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  • Vaccine
  • Gram-negative

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