The Master’s Degree for Industrial Pharmaceutical Process Engineers prepares professional figures that will cover an essential role in pharmaceutical companies and their allied industries.
The course will delve into the responsibilities related to the compliance of technology processes with Good Manufacturing Practices (GMP) for the pharmaceutical industry, in the EU and in all those Non-EU Countries where a pharmaceutical product is approved for sale.
The Master focuses on the pharmaceutical industry and on related engineering, technology and consultancy companies.
The course units of the Master’s Degree for Industrial Pharmaceutical Process Engineers provide the required methods and knowledge to manage the pharmaceutical industry technology processes according to GMP criteria.
Huge emphasis is given to the presentation and discussion of case studies, which allow students to relate to actual situations in the pharmaceutical sector.
The Master will involve a strong participation of professors from the industrial sector, and will be divided into 11 thematic modules, as specified below.
The Master’s Degree for Industrial Pharmaceutical Process Engineers is aimed at pharmaceutical operators, in order to improve their knowledge by engaging with the experience of professors with an academic and professional background, and also at new graduates who want to enter the industrial pharmaceutical sector successfully.
A Pharmaceutical Process Engineer is a sought-after reference figure in many different pharmaceutical fields, such as:
- Pharmaceutical industries that produce active substances and drugs (quality, engineering, production, regulatory areas);
- Pharmaceutical industry engineering and consultancy companies, within GMP compliance & validation;
- Pharmaceutical industry system/machine/technology supplying companies;
- Pharmaceutical industry regulatory agencies.
A Pharmaceutical Process Engineer is involved in all aspects related to the validation of environments, labs, equipment and production processes, and actively takes part in GMP inspections carried out by regulatory authorities.
The Master’s Degree for Industrial Pharmaceutical Process Engineers will educate students on:
Module 1: Fundamentals of process plant equipment
- Matter and energy balance, matter and heat transportation
- Heat exchange and liquid transportation equipment
- Separation and purification: distillation and membrane
Module 2: Good manufacturing practices for pharmaceutical plants and processes
- cGMP Compliance as per EU-GMP and related Annexes
Module 3: Pure fluids in the service of pharmaceutical processes and controlled contamination environments
- Pharmaceutical clean rooms and HVAC systems
- Environmental contamination control technologies
- Pure fluids for pharmaceutical processes
Module 4: Pharmaceutical technologies and processes I
- Technologies for: dissolution and mixing; sterilization and freeze drying; granulation, compression and coating
- Gelled system technologies; main pharmaceutical forms and Pharmacopeia requirements
Module 5: Inspection, packaging, storage and transport of medicinal products
- Storage and transport of pharmaceutical products and validation
- Non-sterile drugs and secondary packaging technologies
- Sterile forms inspection technology: inspection and leak-testing
Module 6: Computerized control systems for pharmaceutical processes and data integrity
- Computerized Control System for Pharmaceutical Processes
- Industrial Pharmaceutical Process Data Integrity
Module 7: Pharmaceutical quality risk management and Quality By Design practices
- Introduction to a statistical Quality By Design approach
- Example of Quality Risk management industrial applications
Module 8: Fundamentals of pharmaceutical biotechnologies
- Basic concepts on bacteria, yeasts and mammal cells
- Introduction to biomolecule production culture cells
- Fermentation plants; industrial bioreactor operating principles
Module 9: GMP inspections on pharmaceutical production sites
- Inspection of pharmaceutical facilities according to EU and International GMP
Module 10: Pharmaceutical technologies and processes II
- Washing, decontamination, sterilization and depyrogenation technologies
- Validation of sterilization and depyrogenation processes
- Liquid and gas filtration and single-use technologies; blow-fill-seal technology
- Production of sterile products in aseptic conditions
- Contamination control in pharmaceutical processes
Module 11: Granulated material, freeze-drying and primary packaging technologies
- General particle technology principles and granulated solid processing equipment
- Filling and primary packaging process technologies; freeze-drying
- Liquid and gas filtration and single-use technologies
The Società di Consulenza Farmaceutica DOC contributes to the Master’s Course organization, and helps to coordinate expert industry professors and organize the internship period within the companies.
The following companies participate and support this Master’s Course:
- Boerhinger Inghelheim
- Brevetti Angela
- Eli Lilly Italia
- Fidia – Pharma Group
- Fresenius Kabi
- ICOS Pharma
- ISPE Italian Affiliate
- Jacobs Italia
- Patheon Thermo Fisher
- PDA Italy Chapter
- Stevanato Group
- Zambon Group
The Master’s Degree for Industrial Pharmaceutical Process Engineer is sponsored by the Agenzia Italiana del Farmaco (AIFA).
In order to enrol in the Master’s Degree for Industrial Pharmaceutical Process Engineers, a Master’s or Specialist Degree is required, or a degree awarded under the previous degree program system in the following:
- Biotechnologies (industrial, pharmaceutical, medical, veterinarian);
- Pharmacy and Chemistry and Pharmaceutical Technology;
- Biomedical Engineering;
- Chemical Engineering;
- Management Engineering;
- Mechanical Engineering;
- Materials Science or Engineering;
- Chemistry or Industrial Chemistry;
Master’s or Specialist Degree (or a degree awarded under the previous degree program system) in other scientific disciplines with a specific interest in this Master’s Course, or who have gained extensive experience in the industrial pharmaceutical sector.
The Master’s Course lessons will be held every 2 to 3 weeks, from November 2022 to September 2023 (except for August 2023), on Thursday and Friday (full day) and on Saturday morning. The lesson plan is designed to facilitate working students, so that they can organize their attendance beforehand. Lessons will be held in-person, at the University of Padua, for a total of 320 hours.
Besides in-person lessons, every student must do a 500-hour traineeship in a company, to put what they learned during the lessons into practice. You can select the company where to do your traineeship among the Master’s partner companies, or it can also be an external company. For working students, the 500-hour traineeship can also include 500 hours of work within the company you are already working for.
Non-working students are required to find a company within the industrial pharmaceutical sector to do their 500-hour traineeship. The Master’s organizing committee and administrative staff will support students in their placement within the companies.
There will be no other mandatory activities. Students will be offered optional activities that may include seminars/lessons on relevant topics, participation to events or trade fairs, visits to companies.
The Master’s Degree foresees the option of a (partial) reimbursement for travel and room/board fees for students coming from different Regions, who attended at least 75% of the lessons. The reimbursement fee will be established based on the actual distance of the applicant’s domicile with respect to the Master’s venue, and the actual amount sustained. In any case, it cannot exceed €2,500. Unfortunately, there are no scholarships or prizes for this course.
You can download the notice of selection under the “Info” section in this page. In addition, you can contact UniSMART’s administrative office (firstname.lastname@example.org) or the Master Director, Prof. Fabrizio Bezzo (email@example.com).