Pharmaceutical Facility Design

Learn about clean utilities, cleanrooms & quality mgmt systems for manufacturing medicines

  • Design cleanroom layout
  • Conduct site master planning
  • Complete course from anywhere online in 10 weeks

Intermediate

Join 1,923 Students Worldwide

Online, 10 weeks, 16 hrs / week

Price   |   Syllabus

Learn about Clean Utilities, Cleanrooms & Quality Management Systems

An injection bypasses all of your body’s natural defenses. How do you make sure that the cleanroom used in the manufacture of sterile medicines are absolutely safe? How do you make sure the water used in these injections is pure? In this practical course, you will learn all this and more.

Learn about the air and water systems used for pharmaceutical manufacturing that underpin aseptic/sterile processing and the quality systems used in this highly regulated environment.
Design the cleanroom layout and the environmental controls pressure profiles necessary to meet the materials and personnel flows in a manufacturing facility.
Design the piping, instrumentation and process control design for the generation and distribution of clean utility systems.
Calculate the mass balance for a process. Conduct site master planning for a new or modified manufacturing facility.
Cleanroom layout for a safe material & personnel flows
Clean Utility generation & distribution system design
Process Design for Equipment Sizing
Environmental Control Design for material and personnel flows
Mechanical-Piping and Electrical-Instrumentation Design
Process Control An Automation
Aseptic Processing and Vial Filling
Site Master Planning & the Project Lifecycle for new Equipment & Systems

Watch Video

Watch a sample video from the course on controlling air quality

Online Learning Done Differently

or: Why this is an Online Course You’ll Actually Finish!

Each week, you’ll complete a series of videos, quizzes, interactive activities and projects through our online platform, available to access 24/7.
Online courses can start off great, but staying motivated can be a challenge. So, you’ll get regular feedback reports (and emails or phone calls if you fall behind!) to keep you on track.
Because it’s online, there are no long commutes, traffic jams or crowded trains to deal with on the way to class. Study at home after the kids have gone to bed.
Your working schedules are unpredictable so we offer flexible delivery. Slow down, speed up or pause the delivery of the course.
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GetReskilled Success Stories
Pharmaceutical Facility Design

Edel Harkins

“I would highly recommend anyone in my situation who has been out of the industry for a period of time to do these courses. They have contributed to my new found confidence in my existing and new qualifications, my improved interview skills and my new job!”

Pharmaceutical Facility Design

Ronan Balfe

“Studying online gives you the time to do the course in your own time yet with assignment deadlines this made you disciplined to meet the deadlines set. I would have no hesitation in recommending these courses to anyone wishing to gain an education in the pharmaceutical sector.”

Pharmaceutical Facility Design

John Ryan

“The professionalism and passion of the lecturers comes across in the tutorials which gives the student confidence and encouragement to keep on top of the course. The course content material is concise and interesting. The timing of the release of the lessons is perfect, the student moves at a comfortable pace, one step at a time.”

Pharmaceutical Facility Design

Noel O’Brien

“The quality of the course content was excellent and very substantial and covered all aspects associated within the Pharmaceutical, Bio-Pharmaceutical and Medical Device industries. Information that I feel could and would be very much a requirement for the type of work I would be seeking, within such companies.”

Pharmaceutical Facility Design

Anne Reilly

“Very important to do a course if you have been absent from workplace for a relatively long period. It just gives you the confidence to do interviews etc.”

Pharmaceutical Facility Design

Louise McManus

“Excellent course, well set out.”

Andy Wnuk, MSc (Eng) MIEI

“Along with the technical training in I would rate the course 10 out 10 and would highly recommend to others, very interesting, informative and very well presented. Relevant totally to my needs and expectations.”

David O’Shea, March 2012

“I found this course very beneficial and I am delighted that, even at early stages in the course, it has already provided me with the opportunity to secure a position within the pharmaceutical industry.”

Denis Hegarty, May 2012

“I found the course was run very professionally, The course notes and videos supplied were excellent, the notes tied in very efficiently and accurately with the videos. Dr Joe Brady’s presentation on the videos and his expertise and help at the webinars was outstanding. I found it very easy to continue studying even though I found employment two months into the course. I would highly recommend this course to anyone hoping to further their education in this field.”

Tan Sear Enyu, Venture Corporation Limited, SA

“The lecturers have vast knowledge to share and are technical specialists within the Life Sciences Industry…there was a lot of encouragement and team exchange of experience to bring in for class work and assignment participation.”

Lecturer

Joe Brady
Joe Brady

Lecturer, Dublin Institute of Technology

Dr. Joe Brady is an assistant lecturer with the Dublin Institute of Technology (DIT), in the School of Chemical and Pharmaceutical Sciences. Joe is a certified trainer, and highly experienced in competency based training. He designs and prepares educational modules and full academic courses ranging from MSc, MEngSc. BSc, to Certificate level, for a range of academic institution.

He is also a supervisor for MSc/MEngSc and PhD theses. Joe has over seventeen years project experience in the pharmaceutical, biopharmaceutical and medical device industries in Ireland, Singapore, China, The Netherlands, France and the USA.

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Syllabus

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.

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Frequently Asked Questions

This is an advanced and high level course and is not comparable to a two day course both in the range of content covered and the detail it goes into. Furthermore, spreading the learning over 10 weeks rather than trying to cramp everything into a three day or one week event means that you will dramatically improve your retention of the materials.
This available worldwide and in certain US States. Contact us for details.

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