Particulate Generation Mechanisms during Bulk Filling and Mitigation via New Glass Vial

Reference

1. 1.↵
   1. Langille S.

   Visual Inspection of Injectables. PDA Visual Inspection Forum, October 2015.
2. 2.↵
   1. Tawde S.

   Particulate Matter in Injectables: Main Cause for Recalls. J. Pharmacovigil. 2014, 3 (1), 1–2.

   OpenUrl
3. 3.↵
   1. Langille S.

   Particulate Matter in Injectable Drug Products. PDA J. Pharm. Sci. Technol. 2013, 67 (3), 186–200.

   OpenUrlAbstract/FREE Full Text
4. 4.↵
   1. Bukofzer S.,
   2. Ayres J.,
   3. Chavez A.,
   4. Devera M.,
   5. Miller J.,
   6. Ross D.,
   7. Shabushnig J.,
   8. Vargo S.,
   9. Watson H.,
   10. Watson R.

   Industry Perspective on the Medical Risk of Visible Particles in Injectable Drug Products. PDA J. Pharm. Sci. Technol. 2015, 69 (1), 123–139.

   OpenUrlFREE Full Text
5. 5.↵
   1. Gould C.

   Lessons Learned from Glass Recalls. PDA/FDA Glass Quality Conference, June 2012.
6. 6.↵
   1. Jack T.,
   2. Brent B. E.,
   3. Boehne M.,
   4. Müller M.,
   5. Sewald K.,
   6. Braun A.,
   7. Wessel A.,
   8. Sasse M.

   Analysis of Particulate Contaminations of Infusion Solutions in a Pediatric Intensive Care Unit. Intensive Care Med 2010, 36 (4), 707–711.

   OpenUrlCrossRefPubMed
7. 7.↵
   1. Walpot H.,
   2. Franke R. P.,
   3. Burchard W. G.,
   4. Agternkamp C.,
   5. Müller F. G.,
   6. Mittermayer C.,
   7. Kalff G.

   Particulate Contamination of Intravenous Solutions and Drug Additives during Long Term Intensive Care. Anesthetist 1989, 38 (10), 544–548.

   OpenUrl
8. 8.↵
   1. Zabir A.,
   2. Choy C. Y.,
   3. Rushdan R.

   Glass Particle Contamination of Parenteral Preparations of Intravenous Drugs in Anesthetic Practice. Southern African Journal of Anesthesia and Analgesia 2008, 14 (3), 17–19.

   OpenUrl
9. 9.↵
   1. Lehr H.,
   2. Brunner J.,
   3. Rangoonwala R.,
   4. Kirkpatrick C. J.

   Particulate Matter Contamination of Intravenous Antibiotics Aggravates Loss of Functional Capillary Density in Postischemic Striated Muscle. Am. J. Respir. Crit. Care Med. 2002, 165 (4), 514–520.

   OpenUrlCrossRefPubMedWeb of Science
10. 10.↵
    1. Schroeder H.,
    2. DeLuca P. P.

    Particulate Matter Assessment of a Clinical Investigation on Filtration and Infusion Phlebitis. Am. J. Hosp. Pharm. 1976, 33 (6), 543–546.

    OpenUrlAbstract
11. 11.↵
    1. Falchuk K. H.,
    2. Peterson L.,
    3. McNeil B. J.

    Microparticulate-Induced Phlebitis. Its Prevention by In-Line Filtration. N. Engl. J. Med. 1985, 312 (2), 78–82.

    OpenUrlCrossRefPubMedWeb of Science
12. 12.↵
    1. Shabushnig J.,
    2. Melchore J. A.,
    3. Geiger M.,
    4. Chrai S.,
    5. Gerger M. E.

    A Proposed Working Standard for Validation of Particulate Inspection in Sterile Solutions. PDA Annual Meeting, Philadelphia, PA, 1995.
13. 13.↵
    1. Aldrich S.

    Historical Perspective and Current Chapters Review. USP Workshop on Particle Size, 2010.
14. 14.↵
    Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice, USDHHS, FDA, CDER, CBER, ORA, September 2004.
15. 15.↵
    1. Woodcock J.

    Reliable Drug Quality: An Unresolved Problem. PDA J. Pharm. Sci. Technol. 2012, 66 (3), 270–272.

    OpenUrlFREE Full Text
16. 16.↵
    1. Le Houerou V.,
    2. Sangleboeuf J. C.,
    3. Dériano S.,
    4. Rouxel T.,
    5. Duisit G.

    Surface Damage of Soda-Lime-Silica Glasses: Indentation Scratch Behavior. J. Non-Cryst. Solids 2003, 316 (1), 54–63.

    OpenUrl
17. 17.↵
    1. Lawn B.,
    2. Wiederhorn S. M.,
    3. Roberts D. E.

    Effect of Sliding Friction Forces on the Strength of Brittle Materials. J. Mater. Sci. 1984, 19 (8), 2561–2569.

    OpenUrl
18. 18.↵
    1. Lawn B.,
    2. Wilshaw R.

    Review Indentation Fracture: Principles and Applications. J. Mater. Sci. 1975, 10 (6), 1049–1081.

    OpenUrlCrossRef
19. 19.↵
    1. Lawn B. R.,
    2. Wiederhorn S. M.,
    3. Johnson H. H.

    Strength Degradation of Brittle Surfaces: Blunt Indenters. J. Am. Chem. Soc. 1975, 59 (9–10), 428–432.

    OpenUrl
20. 20.↵
    1. Grigoriev I. S.

    CRC Handbook of Physical Quantities, 1st ed.; CRC Press: Boca Raton, FL, 1997; p 151.
21. 21.↵
    1. Wong J. Y.

    Theory of Ground Vehicles, 4th ed.; Wiley: New York, 2008; p 29.
22. 22.↵
    1. Schaut R.,
    2. Peanasky J. S.,
    3. DeMartino S. E.,
    4. Schiefelbein S. L.

    A New Glass Option for Parenteral Packaging. PDA J. Pharm. Sci. Technol. 2014, 68 (5), 527–534.

    OpenUrlAbstract/FREE Full Text
23. 23.↵
    Guidance for Industry: Q9 Quality Risk Management, USDHHS, FDA, CDER, CBER, September 2006.