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PDA Journal of Pharmaceutical Science and Technology

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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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Dan Berdovich
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Article Information

vol. 66 no. 3 273-284
DOI 
https://doi.org/10.5731/pdajpst.2012.00862
PubMed 
22634593

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online May 26, 2012.

Copyright & Usage 
© PDA, Inc. 2012

Author Information

  1. James A. Melchore1,* and
  2. Dan Berdovich2
  1. 1Melchore Consulting and
  2. 2Micro Measurement Laboratories
  1. ↵* Correspondence author: james.melchore{at}me.com
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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
    • Conflict of Interest Declaration
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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
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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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More in this TOC Section

  • A Holistic Approach for Filling Volume Variability Evaluation and Control with Statistical Tool
  • 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
  • Quantitative and Qualitative Evaluation of Microorganism Profile Identified in Bioburden Analysis in a Biopharmaceutical Facility in Brazil: Criteria for Classification and Management of Results
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