Skip to main content
  • Main menu
  • User menu
  • Search

Main menu

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore

User menu

  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart

Search

  • Advanced search
PDA Journal of Pharmaceutical Science and Technology
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore
  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart
PDA Journal of Pharmaceutical Science and Technology

Advanced Search

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • Follow pda on Twitter
  • Visit PDA on LinkedIn
  • Visit pda on Facebook
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
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: james.melchore@me.com
Dan Berdovich
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • Figures & Data
  • References
  • Info & Metrics
  • PDF
Loading

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.
    Google Scholar
  2. 2.
    European Pharmacopeia (EP): Particulate Contamination: Sub-visible Particles; Method 2.9.20, 6.0, 1, 302, 2011.
    Google Scholar
  3. 3.
    British Pharmacopeia (BP). Appendix XIII B. Particulate Contamination: Visible Particles; Ph. Eur. Method 2.9.20, I, A322, 2011.
    Google Scholar
  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.
    Google Scholar
  5. 5.↵
    Guidance for Industry. Container Closure Systems for Packaging, Human Drugs and Biologics, Chemistry, Manufacturing and Controls Documentation, FDA, May 1999.
    Google Scholar
  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 TextGoogle Scholar
  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.
    OpenUrlPubMedGoogle Scholar
  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.
    OpenUrlGoogle Scholar
  9. 9.↵
    1. Cherris R
    . Visual Inspection Lifecycle; Particulate and Container/Closure Defects. Paper presented at the PDA Visual Inspection Forum, Bethesda, MD, 2011.
    Google Scholar
  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.
    OpenUrlGoogle Scholar
  11. 11.↵
    1. Melchore J. A.
    Sound practices for consistent human visual inspection. AAPS PharmSciTech 2011, 12 (1), 215– 221.
    OpenUrlPubMedGoogle Scholar
  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.
    Google Scholar
  13. 13.↵
    1. Melchore J. A.
    Establishing a Statistically Sound Manual Inspection Baseline. Paper presented at the PDA Visual Inspection Forum, Bethesda, MD, 2009.
    Google Scholar
  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.
    Google Scholar
  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.
    Google Scholar
  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 TextGoogle Scholar
  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 TextGoogle Scholar
  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.
    OpenUrlGoogle Scholar
  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.
    Google Scholar
  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.
    Google Scholar
  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.
    Google Scholar
  22. 22.↵
    1. Berdovich D.
    Visual Inspection Standards. Paper presented at the PDA Visual Inspection Forum, Bethesda, MD, 2007.
    Google Scholar
  23. 23.↵
    1. Berdovich D.
    Visual Inspection Standards. Paper presented at the PDA Visual Inspection Forum, Bethesda, MD, 2005.
    Google Scholar
  24. 24.
    1. Aldrich S.
    , Particulate Matter—Visual Detection to Identification. Paper presented at the PDA Visual Inspection Forum, Bethesda, MD, 2009.
    Google Scholar
  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.
    Google Scholar
  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.
    OpenUrlGoogle Scholar
  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.
    OpenUrlGoogle Scholar
  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.
    Google Scholar
  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.
    Google Scholar
  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.
    Google Scholar
  31. 31.↵
    1. Dunham A.
    Visible Particulate Matter Detection in LVIs. Paper Presented at the PDA Annual Meeting, Colorado Springs, CO, April 2008.
    Google Scholar
  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.
    Google Scholar
  33. 33.↵
    1. Grieb E.
    Scrutinizing the Sub-Visible, Pharm. Technol. 2010, 35, 44– 48.
    OpenUrlGoogle Scholar
  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.
    Google Scholar
  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.
    Google Scholar
  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.
    Google Scholar
  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.
    Google Scholar
  38. 38.↵
    1. Blackwell H. R.
    Contrast thresholds of the human eye. J. Opt. Soc. Am. 1946, 36 (11), 624– 641.
    OpenUrlCrossRefPubMedWeb of ScienceGoogle Scholar
PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 66 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 66, Issue 3
May/June 2012
  • Table of Contents
  • Index by Author
Print
Download PDF
Article Alerts
Email Article
Citation Tools
Share
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
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget

Jump to section

  • 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
    • Conflict of Interest Declaration
    • References
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • A Proof-of-Concept Study on a Universal Standard Kit to Evaluate the Risks of Inspectors for Their Foundational Ability of Visual Inspection of Injectable Drug Products
  • Definition of Particle Visibility Threshold in Parenteral Drug Products--Towards Standardization of Visual Inspection Operator Qualification
  • 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
  • Google Scholar

More in this TOC Section

  • Worldwide Regulatory Reliance: Results of an Executed Chemistry, Manufacturing, and Control Post-Approval Change Pilot
  • Preservative Efficacy Testing of Refrigerated Pharmaceuticals: Choice of Challenging Isolate and Storage Temperature
  • Analysis of Virus Clearance for Biotechnology Manufacturing Processes from Early to Late Phase Development
Show more Research

Similar Articles

  • Definition of Particle Visibility Threshold in Parenteral Drug Products—Towards Standardization of Visual Inspection Operator Qualification
  • A Proof-of-Concept Study on a Universal Standard Kit to Evaluate the Risks of Inspectors for Their Foundational Ability of Visual Inspection of Injectable Drug Products
  • Best Practices to Quantify and Identify Particulate Matter on the Interior Surfaces of Single-Use Systems
  • Applying Machine Learning to the Visual Inspection of Filled Injectable Drug Products
  • Development and Qualification of Visible Particle Load Analysis Methods for Injectable Drug Product Primary Packaging Components
See more

Readers

  • About
  • Table of Content Alerts/Other Alerts
  • Subscriptions
  • Terms of Use
  • Contact Editors

Author/Reviewer Information

  • Author Resources
  • Submit Manuscript
  • Reviewers
  • Contact Editors

Parenteral Drug Association, Inc.

  • About
  • Advertising/Sponsorships
  • Events
  • PDA Bookstore
  • Press Releases

© 2025 PDA Journal of Pharmaceutical Science and Technology Print ISSN: 1079-7440  Digital ISSN: 1948-2124

Powered by HighWire
Alerts for this Article
Sign In to Email Alerts with your Email Address
Email this Article

Thank you for your interest in spreading the word on PDA Journal of Pharmaceutical Science and Technology.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
Considerations for Design and Use of Container Challenge Sets for Qualification and Validation of Visible Particulate Inspection
(Your Name) has sent you a message from PDA Journal of Pharmaceutical Science and Technology
(Your Name) thought you would like to see the PDA Journal of Pharmaceutical Science and Technology web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
11 + 3 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
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

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero

We use cookies on this site to enhance your user experience

By clicking any link on this page you are giving your consent for us to set cookies.