Week 1 – Controlling Air Quality and Clean Utilities Manufacturing Logistics Calculations

• Process Flow Diagram (PFD)
• Controlling Air Quality
• Heating, Ventilation, and Air Conditioning (HVAC) Systems
• Biopharmaceutical Unit Operations – Drug Substance
• Biopharmaceutical Unit Operations – Drug Product
• Pharmacopeia Grade Waters
• Process Support and Utilities
• Introduction to ISO 9001:2008
• Typical GMP list for drug substance
• Operational Activities
• GMP for Personnel
• Quality Systems Approach to Pharmaceutical cGMP Regulations – The Quality Systems Model
• Maintenance: Good and Best Practices

Week 2 – Purified Water Generation and Distribution

• Project Lifecycle for New and Modified Facilities
• IPlant Layout
• Layout For Bulk Process Building
• Site Layout
• IZoned Air Conditioning System
• Isolator technology
• IIsolators and RABs
• Cell Breakage
• IPurified Water
• Purified Water Generation
• IPurified Water Storage and Distribution
• Clean Room and Clean Air Device Monitoring
• Good Engineering Practices Procedures
• GMPs for Buildings and Facilities
• Maintenance Program

Week 3 – Clean Steam and Sterilization

• Conceptual Design – Part-I
• HAVC Requirements for Non Sterile API Manufacturi
• Plant Automation
• Plant Steam
• Clean Steam Generators
• Clean Steam Generators 2
• Steam Sterilization-In-Place
• GMPs for Process Equipment
• Quality Systems Approach to Pharmaceutical cGMP Regulations – Resources

Week 4 – Controlling Material and Personnel flows

• Conceptual Design – Part-II
• Air Flow Patterns
• Air Flow Patterns Laminar Flow Systems
• Cleanroom Layout General Introduction
• Cleanroom Layout HVAC Containment (non-sterile API manufacturing)
• Filter Ratings – European Standards
• Filter Ratings – MERV Rating
• Logic Gates Functions, and Programmable Logic Controller (PLC)
• Water for Injection (WFI) Storage and Distribution
• Principles of Good Engineering Practices (GEP)
• Quality Systems Approach to Pharmaceutical cGMP Regulations – Manufacturing
• Maintenance Work Execution

Week 5 – Aseptic Processing and Vial Filling

• Site Master Planning – Part-I
• Classification of Clean Areas – Vial Filling
• Classification of Clean Areas – Cleanroom HVAC Configurations
• Classification of Clean Areas – AHU
• Classification of Clean Areas – Particles
• Classification of Clean Areas – CFU
• Area Classification Protection
• Compressed Air, and Pneumatics
• Aseptic Filling – Sterile Medicinal Containers
• Aseptic Filling – Vial Inspection
• Aseptic Filling – Vial Washing
• Aseptic Filling – Vial Depyrogenation
• Aseptic Filling – Vial Filling
• Cleanroom Gowning
• Aseptic Processing – Automated Loading System
• Aseptic Processing – Manual Loading System
• Aseptic Processing – Automated Barrier Systems
• Cleanroom Monitoring – Physical Tests
• Quality System – Evaluation Activities
• Maintenance Management

Week 6 – Controlling Cleanrooms and Automation

• Site Master Planning – Part-II
• Open versus Closed Processing
• Facility Layout Concept
• Blow/fill/seal technology
• PLC Programming
• PLC Program Case Studies
• Cleanroom Monitoring – Microbiological Tests
• Cleanroom Monitoring – Cleanrooms Cleaning Procedures
• Terminally sterilised products
• EU Guidelines on Clean Room Aseptic preparation

Week 7 – Quality Systems for Cleanrooms

• HVAC Critical Parameters for Sterile and Non-Sterile Manufacturing
• Batch Process Control
• Nitrogen Supply and Distribution
• Environmental Monitoring Program
• ICH Q10 – Pharmaceutical Quality System
• FDA Guidance on Aseptic Processing

Week 8 – Construction Lifecycle for New and Modified Facilities

• Construction Lifecycle – New and Modified Facilities
• Construction Lifecycle – Test Packs
• Construction Lifecycle – Modular and Sustainability
• Software Functional Block Diagram (FBD)
• ASTM E 250

Complete the Following Activities & Workshops

You will produce a number of deliverables during the course including:

• Calculating Mass Balances and Equipment Sizing
• Designing a Clean Utility generation and distribution system
• Defining the cleanroom layout for safe material and personnel flows
• Describing the Quality System necessary for manufacturing safe medicines

Complete an End of Module Assignment

Develop a site master plan for an aseptic manufacturing process and the design of its environmental control and clean utility systems.

Certified by GetReskilled

You will receive an end of course certificate from GetReskilled which along with others modules can build into an academic accreditation from the Dublin Institute of Technology (Ireland) subject to the following criteria;

• Passing a written or oral Exam on the materials.
• The submission of all assessments and the end of module assignment.