Center for Pharmaceutical Cleaning Innovation
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    • Cleaning Process Development
    • Method Development
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    • Certified SME in ASTM E3106 Science-Based and Risk-Based Cleaning Process Development and Validation
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Visual Inspection

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The EMA and PIC/S have recently allowed the use of visual inspection to replace analytical testing (swab) at product changeover, if the visual inspection can be demonstrated to be reliable.

CPCI™ has developed a simple, cost effective and statistically-based procedure for qualifying all operators and inspectors to perform a Visual Inspection that has been validated.

CPCI™ has also developed an APP that can simplify data collection and analysis and avoid transcription errors associated with paper-based forms and help assure Data Integrity.

CPCI™ can also provide a "double-blind" qualification study of operators/inspectors as described in ASTM E3263. Contact CPCI™ for more information.

Statistics-based Qualification

CPCI™ is the pioneer in the development of statistically-based qualification of Visual Inspection.  Our research can help you qualify a Visual Inspection program that qualifies all of your operators, is scientifically and statistically defensible, and can speed up the release of equipment for return to manufacturing for significant time and cost savings.

We have also developed patent pending software for bringing visual inspection to the next level.

The Center for Pharmaceutical Cleaning Innovation is a Non-Profit Research Organization providing research and educational opportunities in Cleaning Process Development and Validation
Content Copyright 2022. All rights reserved.
andywalsh@clean6sigma.com
(908) 507-7743

  • Home
    • About
  • Research
    • Cleaning Process Development
    • Method Development
    • Visual Inspection
    • Data Analytics
  • Education Opportunities
    • Certified SME in ASTM E3106 Science-Based and Risk-Based Cleaning Process Development and Validation
    • Certified Lean Six Sigma Green Belt
    • Publications
    • Training, Seminars, Webinars, Internships
  • Contact
  • Store
    • Coupon Page
    • Coupons and Boxes
    • Textbook Page
  • Donations