Syngene Ramaiah Certificate Program in Sterile Manufacturing
August 3, 2023 2024-04-17 6:19Syngene 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
Career Opportunities
Customised Curriculum
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
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B Pharm
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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.
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.