Cleaning Validations Using Extraction Techniques

  • Instructor : Kierstan Andrascik
  • Level : Intermediate
  • Study time : 58 Minutes
  • Course ID: TF1924
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ABOUT THE COURSE

Is your cleaning process validation ready to stand up to regulatory scrutiny?
Are you confident your extraction technique is capturing residual contaminants effectively?
Do you know how to choose the right solvents, parameters, and test limits?


This course gives you a practical, lab-tested approach to cleaning validations—so you can eliminate doubt, prove compliance, and protect patient safety with confidence.


WHAT WILL YOU GAIN
  • A step-by-step guide to validate device cleanliness using extraction methods
  • Know-how to select appropriate contaminants, solvents, and test parameters
  • Confidence that your validation process will hold up under audit


WHY TAKE THIS COURSE
  • Cleaning validation failures are a top reason for regulatory citations
  • Learn extraction from an industry leader who helped define ASTM standards
  • Skip guesswork—use proven techniques that save time and prevent risk


KEY AREAS COVERED
  • Cleaning validation scope and regulatory expectations
  • Contaminant identification and selection of test methods
  • Solvent choice and setting extraction conditions
  • Validation of the extraction process itself
  • Establishing acceptance criteria and contamination limits
  • Real-world considerations for implants, single-use, and reusables

Quality training, expert insights, and answers that matter. Know your Expert

KIERSTAN ANDRASCIK

Kierstan Andrascik is one of the most respected voices in medical device cleanliness today. As the architect of real-world extraction methods that helped shape ASTM F2459, she’s led the field in cleaning validation long before it became a buzzword. With a background in chemistry, years at Nelson Labs, and a deep commitment to patient safety, Kierstan delivers unmatched clarity where it matters most.

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