Interpreting Growth Media and Responding to Action Limit Excursions

Gain the skills to accurately interpret microbial growth on environmental monitoring media and respond effectively to action limit excursions. This lesson covers identifying colony-forming units (CFUs), comparing results to ISO classification limits, documenting findings, and initiating appropriate corrective and preventive actions (CAPAs). Designed to support USP <797>, <1116>, and FDA cGMP compliance in cleanroom environments.

By the end of this lesson, learners will be able to:

  1. Identify and describe colony growth on environmental monitoring media following incubation.
  2. Interpret results based on USP <797>, <1116>, and internal action and alert limits.
  3. Document microbial growth results and determine if an alert or action limit has been exceeded.
  4. Initiate appropriate deviation, investigation, and remediation procedures for action limit excursions.
  5. Complete documentation including CAPA (Corrective and Preventive Action) forms and determine if follow-up actions were effective.

About Instructor

Seth DePasquale, R.Ph., BCSCP

Seth DePasquale is a Board Certified Sterile Compounding Pharmacist and former co-owner of BET Pharm, LLC in Lexington, KY; a compounding pharmacy specializing in long-acting injectable hormone formulations for equine reproduction. Seth's passion for compounding and teaching have combined when he co-founded LyceumCE.com; dedicated to increasing compliance and better practices through video-based continuing pharmacy education.

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Course Includes

  • 1 Lesson
  • 1 Quiz