Syngene Ramaiah Certificate Program in Sterile Manufacturing

Biocon Academy, in partnership with Syngene and MS Ramaiah College of Arts, Science & Commerce, offers this 16-week intensive course to help graduates in Pharmacy and graduates/postgraduates in Microbiology, Biotechnology, and Biochemistry gain a solid understanding of industry practices, procedures, and unit operations, preparing them for operational roles in parenteral medicines manufacturing.

Program Highlights

The 16-week Syngene Ramaiah Certificate Program in Sterile Manufacturing is designed to provide specific job skills with an emphasis on regulatory requirements, manufacturing processes, sterilization, and quality management systems. It aims to help participants secure meaningful employment in sterile manufacturing and contribute effectively with minimal need for additional training.

Career Opportunities

There is significant demand for skilled personnel with the appropriate educational background and training in sterilization practices. Understanding the basic principles of manufacturing processes, sterilization, and quality management systems can help candidates gain entry into the pharmaceutical and biotechnology industries.

Customised Curriculum

The customised curriculum covers a wide range of topics, including an introduction to the pharmaceutical industry, quality management systems, general discipline at manufacturing sites, and manufacturing processes. This course is designed to provide advanced, targeted training to graduate microbiologists, biotechnologists, and pharmacists—making them job-ready and reducing the industry's training time.

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 to Syngene Biopharma manufacturing facilities
Insights to Regulatory backdrop
Job-ready skills with 100% Placement Assistance

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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)

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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 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.

Transport

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.

Meals

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.

Accommodation

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.

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Syngene Ramaiah Certificate Program in Sterile Manufacturing