BP809P VACSemester 81 creditsPractical

VAC Elective — Cleaning Validation / Basic Training in Aseptic Handling Techniques / Impurity Profiling (Practical)

Complete unit-wise syllabus for BP809P VAC as per the PCI B.Pharm NEP 2020 curriculum (Semester 8 — AI Ethics + Clinical + Final Research).

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Course Objectives

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.
Understand aseptic principles that prevent microbial contamination in clean-room work.

Unit-wise Syllabus

3 Units

Option 1: BP809P VAC1 — Cleaning Validation (30 Hours)30 Hours

1. Preparation of a cleaning validation protocol for a tablet machine
2. Calculation of MACO (Maximum Allowable Carry Over)
3. Swab sampling technique demonstration using stainless steel surface
4. Rinse sampling technique for equipment residue detection
5. Visual inspection for equipment cleanliness (case photos/videos)
6. Preparation of recovery study protocol using a known contaminant
7. Demonstration of Total Organic Carbon (TOC) analysis (video/simulation)
8. HPLC method development for residue analysis (demo dataset)
9. Interpretation of swab analysis results and comparison with acceptance limits
10. Preparation of cleaning log sheet and checklists
11. Validation of cleaning agents: detergent effectiveness and rinsibility
12. Determining dirty hold time and clean hold time experimentally (conceptual)
13. Designing a matrix approach for multi-product equipment
14. Simulated deviation report and CAPA for cleaning failure
15. Preparation of a final cleaning validation summary report

Option 2: BP809P VAC2 — Basic Training in Aseptic Handling Techniques (30 Hours)30 Hours

1. Gown-up / Gown-down Drill – correct sequencing of coverall, hood, mask, goggles, gloves, and sterile boots.
2. Hand-washing Verification – surgical scrub with UV lotion; inspect under UV lamp for missed spots.
3. Clean-room Entry & Flow Simulation – air-shower pass, unidirectional walking, and material air-lock transfer.
4. LAF Hood Preparation – wipe-down with sporicidal, set airflow, place sterile tools in first-air zone.
5. Smoke-pattern Test – visualize HEPA downflow with smoke to confirm laminar, turbulence-free air.
6. Aseptic Liquid Transfer – pipette or syringe transfer of TSB between vials without touching non-sterile surfaces.
7. Sterile Filtration & Filter Integrity Check – filter a buffer through 0.22 µm unit and perform bubble-point test.
8. Mini Media-Fill – fill 20 sterile vials with TSB under LAF, incubate, and record turbidity for 14 days.
9. Environmental & Personnel Monitoring – deploy settle/contact plates, take glove-fingertip prints, run an air sampler.
10. Cleaning & ATP Validation – full hood wipe-down, then ATP swab pre- and post-clean to verify < 200 RLU residue.

Option 3: BP809P VAC3 — Impurity Profiling (30 Hours)30 Hours

1. Identification of organic impurities in bulk drugs using TLC
2. Quantification of impurities using HPLC
3. Determination of residual solvents by GC (as per ICH Q3C)
4. UV-spectrophotometric analysis of degradation products
5. Preparation of forced degradation samples (acid/base/hydrolytic)
6. Identification of degradation products via IR spectroscopy
7. Extraction and analysis of impurities from finished dosage forms
8. Impurity profiling of marketed paracetamol tablet using HPLC
9. Qualification of impurities as per ICH Q3A/Q3B guidelines
10. Limit test for heavy metals (as per IP)
11. Estimation of elemental impurities by ICP-MS or simulated method
12. Determination of related substances in antibiotics (e.g., cephalosporins)
13. Use of LC-MS data interpretation for impurity identification (demo/simulated)
14. Impurity profiling of herbal products using HPTLC
15. Report preparation on impurity profiling as per regulatory requirements

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Recommended Textbooks & References

1. Cleaning Validation: A Practical Approach – David M. Blenkinsopp & Roy T. Harvey, CRC Press
Cleaning Validation in Pharmaceutical Manufacturing – Trevor Deeks, CRC Press
Pharmaceutical Cleaning Validation: The Basics – Andrew Walsh, Interpharm Press
Cleaning and Cleaning Validation: Volume 1 – Syed Imtiaz Haider, Informa Healthcare
Validation of Cleaning Processes in Pharmaceuticals and Biopharmaceuticals – Jeanne Moldenhauer, DHI Publishing
Pharmaceutical Equipment Cleaning: Fundamentals, Applications and Validations – Gail Sofer, CRC Press
1. Akers J, Moldenhauer J, editors. Aseptic Processing: A Review of Current Industry Practice. 2nd ed. Boca Raton: CRC Press; 2022.
Smith C. Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality. 2nd ed. New York: Springer; 2020.

What's coming next on this page

Previous year question papers (PYQ)
Topic-wise short notes and revision summaries
MCQs and self-assessment quizzes
Suggested external resources and video tutorials

Other subjects in Semester 8

BP801TEthical Considerations and Translational Applications of AI in Pharmacy BP802TClinical Pharmacotherapeutics BP803TIndustrial Pharmacy and Facility Design BP804TPharmaceutical Management BP805TSterile Dosage Forms and Novel Drug Delivery System BP806T AECAEC Elective — Pharmaceutical Packaging / Supply Chain / Industrial Safety / Traditional Healing / AR-VR Pharma 4.0 / Herbal Cosmetics BP807PPharmaceutical Marketing Skills (Practical)BP808PSterile Dosage Forms and Novel Drug Delivery System (Practical)BP810RPResearch Project (Final Submission)

BP801T