UNIQUE SERIES AKTU Syllabus
BP809P VAC1

Cleaning Validation (Practical)

L-T-P0-0-2 Session2026-27 TypeLab / Practical
Appears in 1 semester

B.Pharm · Sem 8 (VAC – Elective 8)

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List of Experiments / Activities

  1. Cleaning Validation (Practical) Elective Credit Hours Per Week (L-T-P) Max. Hours L T P
  2. 1-- --
  3. 30Maximum Marks SE ESE
  4. (Perform any 12 Experiments)
  5. 1Preparation of a cleaning validation protocol for a tablet machine
  6. 2Calculation of MACO (Maximum Allowable Carry Over)
  7. 3Swab sampling technique demonstration using stainless steel surface
  8. 4Rinse sampling technique for equipment residue detection
  9. 5Visual inspection for equipment cleanliness (case photos/videos)
  10. 6Preparation of recovery study protocol using a known contaminant
  11. 7Demonstration of Total Organic Carbon (TOC) analysis (video/simulation)
  12. 8HPLC method development for residue analysis (demo dataset)
  13. 9Interpretation of swab analysis results and comparison with acceptance limits
  14. 10Preparation of cleaning log sheet and checklists
  15. 11Validation of cleaning agents: detergent effectiveness and rinsibility
  16. 12Determining dirty hold time and clean hold time experimentally (conceptual)
  17. 13Designing a matrix approach for multi-product equipment
  18. 14Simulated deviation report and CAPA for cleaning failure
  19. 15Preparation of a final cleaning validation summary report
Course Objectives6 points
  • The objectives of this course are:
  • To understand the importance of cleaning validation in pharmaceutical manufacturing.
  • To familiarize students with the regulatory requirements for cleaning validation.
  • To teach methods for residue detection and the development of cleaning protocols.
  • To explore different analytical techniques used in cleaning validation.
  • To develop skills in writing cleaning validation reports and ensuring compliance.
Course Outcomes (COs)5 outcomes

After completion of the course student will be able to:

  1. CO1Explain the purpose and importance of cleaning validation.
  2. CO2Develop cleaning validation protocols and methods for pharmaceutical equipment.
  3. CO3Understand and apply residue detection techniques such as HPLC and TOC.
  4. CO4Evaluate cleaning effectiveness and compliance with regulatory standards.
  5. CO5Prepare detailed cleaning validation reports and perform revalidation when necessary.
Recommended References (Preferably latest edition):6 books
  1. Cleaning Validation: A Practical Approach David M. Blenkinsopp & Roy T. Harvey, CRC Press
  2. Cleaning Validation in Pharmaceutical Manufacturing Trevor Deeks, CRC Press
  3. Pharmaceutical Cleaning Validation: The Basics Andrew Walsh, Interpharm Press
  4. Cleaning and Cleaning Validation: Volume 1 Syed Imtiaz Haider, Informa Healthcare
  5. Validation of Cleaning Processes in Pharmaceuticals and Biopharmaceuticals Jeanne Moldenhauer, DHI Publishing
  6. Pharmaceutical Equipment Cleaning: Fundamentals, Applications and Validations Gail Sofer, CRC Press Course Title Course Type

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Official AKTU syllabus

This subject is on page 290, 291, 292 of the original AKTU PDF.

Official AKTU syllabus PDF ↗