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Research ArticleResearch

Considerations for Design and Use of Container Challenge Sets for Qualification and Validation of Visible Particulate Inspection

James A. Melchore and Dan Berdovich
PDA Journal of Pharmaceutical Science and Technology May 2012, 66 (3) 273-284; DOI: https://doi.org/10.5731/pdajpst.2012.00862
James A. Melchore
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  • For correspondence: james.melchore@me.com
Dan Berdovich
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  • Article
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References

  1. 1.↵
    USP (USP) Particulate Matter in Injections, 〈788〉; Particulate Matter in Ophthalmic Solutions 〈789〉; Methods for the Determination of Particulate Matter in Injections and Ophthalmic Solutions, 〈1788〉, USP 34-NF 29, 2011.
  2. 2.
    European Pharmacopeia (EP): Particulate Contamination: Sub-visible Particles; Method 2.9.20, 6.0, 1, 302, 2011.
  3. 3.
    British Pharmacopeia (BP). Appendix XIII B. Particulate Contamination: Visible Particles; Ph. Eur. Method 2.9.20, I, A322, 2011.
  4. 4.↵
    Japanese Pharmacopoeia (JP). Insoluble Particulate Matter Test for Injections: The Ministry of Health, Labor and Welfare Ministerial Notification No. 285, 15, 6.07, 110, 2007.
  5. 5.↵
    Guidance for Industry. Container Closure Systems for Packaging, Human Drugs and Biologics, Chemistry, Manufacturing and Controls Documentation, FDA, May 1999.
  6. 6.
    Technical Report No. 43. Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for Pharmaceutical Manufacturing. PDA J. Pharm. Sci. Technol. 2007, 61, 1– 31.
    OpenUrlAbstract/FREE Full Text
  7. 7.↵
    Technical Report No. 27. Pharmaceutical Package Integrity Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for Pharmaceutical Manufacturing. PDA J. Pharm. Sci. Technol. 1998, 52, 1– 48.
    OpenUrlPubMed
  8. 8.↵
    1. Knapp J. Z.,
    2. Kushner H. K.
    Generalized methodology for evaluation of parenteral inspection procedures. J. Parent. Drug Assoc. 1980, 34 (1), 14– 61.
    OpenUrl
  9. 9.↵
    1. Cherris R
    . Visual Inspection Lifecycle; Particulate and Container/Closure Defects. Paper presented at the PDA Visual Inspection Forum, Bethesda, MD, 2011.
  10. 10.↵
    1. Borchert S. J.,
    2. Abe A.,
    3. Aldrich S.,
    4. Fox L. E.,
    5. Freeman J. G.,
    6. White R. W.
    ; Particulate matter in parenteral products: a review. J. Parent. Sci. Technol. 1986, 40 (5), 212– 241.
    OpenUrl
  11. 11.↵
    1. Melchore J. A.
    Sound practices for consistent human visual inspection. AAPS PharmSciTech 2011, 12 (1), 215– 221.
    OpenUrlPubMed
  12. 12.↵
    1. Shabushnig J. G.,
    2. Melchore J. G.,
    3. Geiger M.,
    4. Chrai S.,
    5. Gerger M. E.
    A Proposed Working Standard for the Validation of Particulate Inspection in Sterile Solutions. Paper presented at the PDA Annual Meeting, Philadelphia, PA, 1994.
  13. 13.↵
    1. Melchore J. A.
    Establishing a Statistically Sound Manual Inspection Baseline. Paper presented at the PDA Visual Inspection Forum, Bethesda, MD, 2009.
  14. 14.↵
    1. Melchore J. A.,
    2. Berdovich D.
    Design and Use of Challenge Sets for Inspection Studies. Paper presented at the PDA Visual Inspection Forum, Bethesda, MD, 2011.
  15. 15.↵
    1. Knapp J. Z.
    The Bridge between Visible Particle Data and the Accuracy and Repeatability Requirements of PAT, One Safe Step at a Time. Paper presented at the PDA Visual Inspection Forum, Bethesda, MD, 2005.
  16. 16.
    1. Knapp J. Z.
    The scientific basis for visible particle inspection. PDA J. Pharm. Sci. Technol. 1999, 53 (6), 291– 302.
    OpenUrlAbstract/FREE Full Text
  17. 17.↵
    1. Melchore J. A.
    Prerequisites for optimized performance of the Eisai 1088W Automated Inspection System. PDA J. Pharm. Sci. Technol. 2010, 64 (6), 574– 580.
    OpenUrlAbstract/FREE Full Text
  18. 18.
    1. Knapp J. Z.,
    2. Abramson L. R.
    Automated particulate inspection systems: strategies and implications. J. Parent. Sci. Technol. 1990, 44, 74– 107.
    OpenUrl
  19. 19.↵
    1. Borchert S. J.,
    2. Maxwell R. J.,
    3. Davidson R. L.,
    4. Aldrich D. S.
    Standard particulate sets for visual inspection systems: their preparation, evaluation and applications. J. Parent. Sci. Technol. 1986, 40 (6), 265.
  20. 20.↵
    1. Leversee R. L.,
    2. Shabushnig J. G.
    A Survey of Industry Practice for the Visual Inspection of Injectable Products (PDA Preliminary Report). Paper presented at the PDA Visual Inspection Forum, Berlin, Germany, 2008.
  21. 21.↵
    1. Leversee R. L.,
    2. Shabushnig J. G.
    The Use of Standard Particles in the Qualification, Validation, and Routine Control of Visual Inspection Operations. Paper presented at the PDA Visual Inspection Forum, Bethesda, MD, 2009.
  22. 22.↵
    1. Berdovich D.
    Visual Inspection Standards. Paper presented at the PDA Visual Inspection Forum, Bethesda, MD, 2007.
  23. 23.↵
    1. Berdovich D.
    Visual Inspection Standards. Paper presented at the PDA Visual Inspection Forum, Bethesda, MD, 2005.
  24. 24.
    1. Aldrich S.
    , Particulate Matter—Visual Detection to Identification. Paper presented at the PDA Visual Inspection Forum, Bethesda, MD, 2009.
  25. 25.↵
    1. Cherris R. T.
    Visible Particle Inspection, Microscopy, and Characterization—Tools Supporting Visual Inspection Acceptance Criteria. Paper presented at the PDA Visual Inspection Forum, Bethesda, MD, 2005.
  26. 26.↵
    1. Rathore N.,
    2. Chen C.,
    3. Gonzalez O.,
    4. Wenchang J.
    Challenges and strategies for implementing automated visual inspection for biopharmaceuticals. Pharmaceutical Technology, Injectable Drug Delivery Supplement 2009, 33, S25– S29.
    OpenUrl
  27. 27.↵
    1. Singh S. K.,
    2. Rathore N.,
    3. McAuley A.,
    4. Rathore A. S.
    Best practices for formulation and manufacturing of biotech drug products. BioPharm Int. 2009, 22, 32– 48.
    OpenUrl
  28. 28.↵
    1. Shnek D,
    2. Carrion-Martinez M.,
    3. Gigh A.,
    4. Segarra E.,
    5. Bruno M,
    6. Aquino A.,
    7. Paranandi M.
    Comparing Manual and Automated Inspection of Seeded Syringe Defects. Paper presented at the PDA Visual Inspection Forum, Bethesda, MD, 2007.
  29. 29.↵
    1. Gidh A.,
    2. Carrion-Martinez M.,
    3. Cai X.,
    4. Paranandi M.,
    5. Shnek D.
    Particle Standard Sets for Automated Syringe Inspection. Paper presented at the PDA Visual Inspection Forum, Bethesda MD, 2007.
  30. 30.↵
    1. Deng S.,
    2. Shnek D.,
    3. Carrion-Martinez M.,
    4. Dompenciel R.,
    5. Baez L.,
    6. Sullivan J.,
    7. Sing N.,
    8. Ruhl S.
    Evaluation of Automated Visual Inspection (AVI) Technologies for Biologic Products. Paper presented at the PDA Annual Meeting, Las Vegas, NV, 2009.
  31. 31.↵
    1. Dunham A.
    Visible Particulate Matter Detection in LVIs. Paper Presented at the PDA Annual Meeting, Colorado Springs, CO, April 2008.
  32. 32.↵
    1. McCormick S.,
    2. Bariexca S.
    Glass Sphere vs. Glass Shard Particle Detection Equivalency Using Automatic Static Division Inspection. Paper presented at the PDA Visual Inspection Forum, Berlin, Germany, 2010.
  33. 33.↵
    1. Grieb E.
    Scrutinizing the Sub-Visible, Pharm. Technol. 2010, 35, 44– 48.
    OpenUrl
  34. 34.↵
    1. Berdovich D.
    USP 〈788〉, USP 〈789〉 Issues in Measuring Particles. Paper presented at the USP Workshop on Particles, Rockville, MD, Dec. 8–10, 2010.
  35. 35.↵
    1. Knapp J. Z.
    Overview of Accurate NIST Sized Dimensions of Visible Particle Contamination Data in Sealed Containers of Injectable Products: An Essential Validation and Product Acceptance Tool. Paper presented at the PDA Visual Inspection Forum, Bethesda, MD, 2007.
  36. 36.↵
    1. Budd G. W.
    Referee Level NIST Traceable Particle Contaminating Particle Standards in Sealed Containers Used for the Creation of a Visible Calibration Curve. Paper presented at the PDA Visible Inspection Forum, Bethesda, MD, 2009.
  37. 37.↵
    1. Budd G. W.
    Optimizing the Correlation of Automated Inspection Data Obtained from Electronic Sensors to (NIST Traceable) Referee Level Particle Standards. Paper presented at the PDA Visual Inspection Forum, Bethesda, MD, 2009.
  38. 38.↵
    1. Blackwell H. R.
    Contrast thresholds of the human eye. J. Opt. Soc. Am. 1946, 36 (11), 624– 641.
    OpenUrlCrossRefPubMedWeb of Science
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PDA Journal of Pharmaceutical Science and Technology: 66 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 66, Issue 3
May/June 2012
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Considerations for Design and Use of Container Challenge Sets for Qualification and Validation of Visible Particulate Inspection
James A. Melchore, Dan Berdovich
PDA Journal of Pharmaceutical Science and Technology May 2012, 66 (3) 273-284; DOI: 10.5731/pdajpst.2012.00862

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Considerations for Design and Use of Container Challenge Sets for Qualification and Validation of Visible Particulate Inspection
James A. Melchore, Dan Berdovich
PDA Journal of Pharmaceutical Science and Technology May 2012, 66 (3) 273-284; DOI: 10.5731/pdajpst.2012.00862
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  • Article
    • Abstract
    • Introduction
    • The Role of Challenge Sets for Inspection Qualification/Validation
    • Considerations in the Design and Use of a Challenge Set
    • Challenge Sets Made from NIST-Traceable Spheres versus Real Particles
    • Matrix Grouping for Qualification/Validation of Multiple Products
    • Preparation of Specific Challenge Sets
    • Summary
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  • A Biopharmaceutical Industry Perspective on the Control of Visible Particles in Biotechnology-Derived Injectable Drug Products
  • Semi-Quantitative Analysis of Inherent Visible Particles for Biopharmaceutical Products
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