UNIQUE SERIES AKTU Syllabus
BP708T AEC2

Pharmaceutical Automation (Theory)

L-T-P1-0-0 Session2026-27 TypeTheory
Appears in 1 semester

B.Pharm · Sem 7 (AEC – Elective 6)

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Syllabus

5 units · 15 lecture hours
Unit1

Unit 1

3 hrs

Introduction to Automation in Pharmaceuticals Definition and scope of automation in pharmaceutical industry Importance and benefits: accuracy, efficiency, cost-effectiveness, compliance Types of automation: fixed, programmable, flexible Application areas: production, packaging, quality control, warehousing Challenges and limitations of automation

Unit2

Unit 2

3 hrs

Automated Manufacturing Systems Principles of automated tablet compression, capsule filling, liquid filling, and coating machines PLC-based machinery in granulation and drying Robotics in sterile product manufacturing (isolators, RABS) Continuous manufacturing vs. batch processing Automation in aseptic processing and lyophilization

Unit3

Unit 3

3 hrs

Process Control and Instrumentation Sensors and transducers: temperature, pressure, flow, pH, conductivity Introduction to SCADA (Supervisory Control and Data Acquisition) systems Distributed Control Systems (DCS) in pharma Process Analytical Technology (PAT) definition and applications Basics of automation programming (ladder diagrams, logic gates overview only)

Unit4

Unit 4

3 hrs

Quality Control and Laboratory Automation Automation in analytical laboratories: HPLC, UV, FTIR, dissolution testers Laboratory Information Management System (LIMS) Integration of instruments with software and data loggers Automated sampling and testing methods Role of AI/ML in predictive quality assurance

Unit5

Unit 5

3 hrs

Regulatory Aspects and Emerging Trends Regulatory expectations: USFDA, WHO, EMA on automation & electronic systems 21 CFR Part 11 electronic records and signatures Data integrity and ALCOA Emerging trends: IoT, Industry 4.0, cloud-based manufacturing, AI in pharma Case studies: automated systems in top pharma companies

Course Objectives6 points
  • The objectives of this course are to:
  • Introduce the fundamental concepts of automation technologies used in the pharmaceutical industry.
  • Explain the application of automated systems in pharmaceutical manufacturing, quality control, and packaging operations.
  • Describe the principles of process instrumentation, SCADA, PLC, and robotics in pharmaceutical production environments.
  • Develop understanding of laboratory automation systems including LIMS and Process Analytical Technology (PAT).
  • Examine regulatory considerations and emerging trends in pharmaceutical automation and digital manufacturing.
Course Outcomes (COs)5 outcomes

After completion of the course student will be able to:

  1. CO1Explain the principles and advantages of automation in pharmaceutical processes.
  2. CO2Identify and describe various automated systems used in production and quality control.
  3. CO3Apply knowledge of instrumentation and control systems like SCADA and PLC in pharma environments.
  4. CO4Analyze the role of automation in enhancing data integrity, regulatory compliance, and productivity.
  5. CO5Evaluate new trends like Industry 4.0, IoT, and AI applications in pharmaceutical automation.
Recommended References (Preferably latest edition):7 books
  1. Automation and Control in the Pharmaceutical Industry by Burton H. Sage, CRC Press
  2. Pharmaceutical Engineering by K. Sambamurthy, New Age International Publishers
  3. Process Automation Handbook by Jonathan Love, Springer-Verlag London Ltd.
  4. Industrial Automation and Robotics by Mikell P. Groover, Pearson Education
  5. Instrumentation and Process Control by Terry L.M. Bartelt, Cengage Learning
  6. Good Automated Manufacturing Practice (GAMP 5 Guide) by ISPE (International Society for Pharmaceutical Engineering), ISPE Publications
  7. Pharmaceutical Manufacturing Handbook: Production and Processes by Shayne Cox Gad, Wiley-Interscience Course Title Course Type

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Official AKTU syllabus

This subject is on page 260, 261, 262, 263 of the original AKTU PDF.

Official AKTU syllabus PDF ↗