Syngene Ramaiah Certificate Program in Sterile Manufacturing

Syngene Ramaiah Certificate Program in Sterile Manufacturing

Biocon Academy partners with Syngene and MS Ramaiah College of Arts, Science & Commerce to offer this 16-week intense course aimed at helping the graduates of Pharmacy, Microbiology, Biotechnology & Biochemistry

background to gain adequate background on the industry, practices and procedures including unit operations and then land on operational functions of parenteral medicines manufacturing.

Program Highlights

The 16 weeks Syngene Ramaiah Certificate Program in Sterile Manufacturing aims at providing specific job skills with emphasis on Regulatory requirements, Manufacturing Processes, Sterilization and Quality Management Systems background to help the participants to find meaningful employment in the sterilization function and start delivering with very less need for training.

Career Opportunities

There is a significant demand for skilled personals with appropriate education background and training in sterilization practices. Understanding the basic principles of Manufacturing Processes, Sterilization and Quality Management Systems background will help to get an entry to the industry.

Customised Curriculum

With a customised curriculum, modules encompass vast topics like Introduction to Pharma Industry, Quality Management Systems, General Discipline at Manufacturing Sites & Manufacturing Processes. This course is aimed at providing high end, specific training to the Graduate microbiologists, biotechnologists, and pharmacists, to make them readily employable and reduce the time taken by the industry to train them.

Key Differentiators

  • Enhancing the employability of under graduates
  • Detailed overview of Parenteral manufacturing unit operation
  • Exposure to Sterile operations
  • One-week Hands-on training
  • Intensive Industrial Visits
  • Insights to Regulatory backdrop
  • Job-ready skills with 100% Placement Assistance

About the Course

Introduction to Pharma Industry
  • Overview of Pharma Industry
  • Understanding APIs, Excipients, Formulations, Sterile, Non-sterile
  • How Medicines cure diseases
  • Expiry, Licenses, Precautions from Labels
  • Biological Products & Markets: Small molecules and difference between SM and LM and Biologics
  • Life Cycle of a Drug Product
Quality Management Systems
  • Good Manufacturing Practices
  • Good Documentation Practices: ALCOA++, Examples for each component
  • Regulatory Framework
General Discipline at Manufacturing Sites
  • Do’s & Don’t While in Manufacturing Premises
  • Entry & Exit Procedures
  • Basics of EHS
Manufacturing Processes
  • Parenteral Preparation Flow
  • Equipment
  • Documentation
  • Validation
  • Engineering
  • Utilities
  • Microbiology
  • Cleanroom Design
  • Stability, Storage and Distribution
Sterilization I - Terminal Sterilization
  • Types of Sterilization and Sterilization decision tree
  • Types of autoclave
  • Autoclave: Principles and operations- D, Z, F0 Values
  • Autoclave cycle development
  • Autoclave cycle validation
  • Introduction to Gamma irradiation
  • Validation of Gamma irradiation
  • Pyrogens and depyrogenation through dry heat
  • Gaseous and Radiation based sterilization
Sterilization II - Aseptic Processing
  • Introduction to Biopharmaceutical Manufacturing
  • Introduction to formulation and mixing technologies
  • Filter sterilization- Types of filters, Filter selection
  • Filtration train – design and volume maximization
  • Filter integrity testing
  • Filter validation
  • Aseptic Process Validation (media fill) Emphasis on aseptic techniques and behaviour (PDA Tech Report 26)

Eligibility Criteria

Education Qualification

  • B Pharm

  • BSc./MSc., Microbiology/Biotechnology/Biochemistry

Minimum CGPA/Percentage Required

  • CGPA: 6 and above on a scale of 10
  • Percentage: 60% and above

Break in education of 1 year and less from HSC/PUC to the current highest degree, and break in career for up to a year is permissible.

Adherence to the eligibility criteria is mandatory. Kindly note the same and apply only if you fit the desired eligibility criteria as mentioned above.

Program Fee & Scholarship

The Syngene Merit Scholarship of 60%-75% of the program cost offered to all selected students will enable them to pursue this one-of-its-kind program at an affordable cost.

Student Share: INR 50,000 + 18% GST

Student Facilities

At Biocon Academy, the students have to go through a rigorous curriculum so that by the time their course comes to an end, they are industry-ready and sought after by multiple companies. We encourage them to remain focussed and excel in everything they do. For the benefit of the students, we assist them with a couple of facilities to ensure they just focus on the curriculum.

Industry Placements

At Biocon Academy, we provide 100% interview opportunities to all our students. Ever since inception, Biocon Academy has witnessed 100% placement record in all the courses and batches with students being selected for leading pharma and biopharma companies and startups.


We understand that commuting to different locations for industry training can get challenging especially when students have to arrange for it themselves. Therefore, students are provided with group transport facilities from Biocon Academy to different training locations and then back to the Academy.


Throughout the course, Biocon Academy students are provided with nutritious and sumptuous lunch at the Biocon Academy premises. They also have access to beverage vending machines for tea, coffee, and milk throughout the day.


Students come to pursue studies at Biocon Academy from different parts of the country and upon their request, we provide options of nearby paying guests and hostel accommodations based on the previous student choices. Kindly note that students and their parents/guardians alone are responsible for any decision taken regarding their stay.

Your Career Starts Here!