UNIQUE SERIES AKTU Syllabus
BP809P VAC2

Basic Training in Aseptic Handling Techniques (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. Basic Training in Aseptic Handling Techniques (Practical) Elective Credit Hours Per Week (L-T-P) Max. Hours L T P
  2. 1-- --
  3. 30Maximum Marks SE ESE
  4. 1Gown-up / Gown-down Drill correct sequencing of coverall, hood, mask, goggles, gloves, and sterile boots.
  5. 2Hand-washing Verification surgical scrub with UV lotion; inspect under UV lamp for missed spots.
  6. 3Clean-room Entry & Flow Simulation air-shower pass, unidirectional walking, and material air-lock transfer.
  7. 4LAF Hood Preparation wipe-down with sporicidal, set airflow, place sterile tools in first-air zone.
  8. 5Smoke-pattern Test visualize HEPA downflow with smoke to confirm laminar, turbulence-free air.
  9. 6Aseptic Liquid Transfer pipette or syringe transfer of TSB between vials without touching non-sterile surfaces.
  10. 7Sterile Filtration & Filter Integrity Check filter a buffer through 0.22 µm unit and perform bubble-point test.
  11. 8Mini Media-Fill fill 20 sterile vials with TSB under LAF, incubate, and record turbidity for 14 days.
  12. 9Environmental & Personnel Monitoring deploy settle/contact plates, take glove-fingertip prints, run an air sampler.
  13. 10Cleaning & ATP Validation full hood wipe-down, then ATP swab pre- and post-clean to verify < 200 RLU residue.
Course Objectives6 points
  • The objectives of this course are:
  • Understand aseptic principles that prevent microbial contamination in clean-room work.
  • Learn correct gowning and hand-hygiene steps for ISO-classified areas.
  • Practise safe techniques for setting up laminar-airflow hoods and transferring sterile materials.
  • Carry out routine monitoring of surfaces, air, and personnel to verify sterility.
  • Document procedures accurately to meet GMP and audit requirements.
Course Outcomes (COs)5 outcomes

After completion of the course student will be able to:

  1. CO1Explain the key concepts of asepsis, clean-room classifications, and contamination control.
  2. CO2Demonstrate full sterile gown-up and hand-wash without contamination spots.
  3. CO3Set up and operate a laminar-airflow workstation and perform aseptic liquid transfers with no spills.
  4. CO4Complete a mini media-fill that meets sterility acceptance criteria (> 95 % clear vials).
  5. CO5Record and interpret environmental and personnel monitoring data, flagging any values above action limits.
Recommended References (Preferably latest edition):4 books
  1. Akers J, Moldenhauer J, editors. Aseptic Processing: A Review of Current Industry Practice. 2nd ed. Boca Raton: CRC Press; 2022.
  2. Smith C. Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality. 2nd ed. New York: Springer; 2020.
  3. Vanderhaegen B. Cleanroom Design: Concepts and Practice. 3rd ed. London: Wiley; 2019.
  4. Sandle T. Cleanroom Microbiology. 1st ed. Boca Raton: CRC Press; 2021. Course Title Course Type

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Official AKTU syllabus

This subject is on page 292, 293, 294 of the original AKTU PDF.

Official AKTU syllabus PDF ↗