Pharmaceutical Facility Design

Pharmaceutical Facility Design. Learn ONLINE the Systems that Underpin Aseptic/Sterile Processing

How do you make sure that the cleanrooms used in the manufacture of sterile medicines are absolutely safe? How do you make sure the water, steam and air used are pure? In this practical course, you will learn all this and more.
  • Learn the air, water and steam systems that underpin aseptic/sterile processing
  • Conduct site master planning and cleanrooom design
  • Complete course from anywhere online in 10 weeks
  • Application Deadline: Wednesday 2nd December

Pharmaceutical Facility Design. Learn ONLINE the Systems that Underpin Aseptic/Sterile Processing

How do you make sure that the cleanrooms used in the manufacture of sterile medicines are absolutely safe? How do you make sure the water, steam and air used are pure? In this practical course, you will learn all this and more.
Principles of Pharmaceutical Facility Design Course GetReskilled

Our learners work for the world’s biggest pharma and medical device companies

Pfizer Logo

Abbott Logo

Novartis Logo

GSK Logo

Lilly Logo

Novartis Logo

MSD Logo

Boston Scientific Logo

Medtronic Logo

Takeda Logo

Abbvie Logo

J&J Logo

DURATION
1 Module over 10 Weeks
Study Online 16 hrs/week 

LEVEL
Intermediate
Join 1923 Learners

APPLY BY
Wednesday 2nd Dec
Class Starts: 10th Dec

See Pricing

Apply NOW for this course

This Course is For You If;

  • You work in or are responsible for making sure the cleanroom and utilities are sterile and safe.

  • You are responsible for planning the personnel and material flows and pressure profiles to prevent cross-contamination in sterile manufacturing environments.

  • You need an in-depth program on how the systems that underpin aseptic/sterile processing are designed and run.

And..

  • You want end-of-week progress checks and follow by us to MAKE SURE you finish the course.

  • Delivered Online you can keep working and still study without wasting your time or money or training budget on hotel or travel junkets.

Air and Water Systems

Learn about the systems that underpin aseptic/sterile processing.

Instrumentation and Process Control Design

Design for the generation and distribution of clean utility systems.

Cleanroom Layout

Design cleanroom layout & environmental controls pressure profiles.

Calculate the Mass Balance

Conduct site master planning for a new or modified manufacturing facility.

Aseptic Processing and Vial Filling

Learn cleanroom classification and how vials are filled in an aseptic environment.

Quality Systems for Cleanrooms

Learn about EU and FDA Guidance on Aseptic Processing.

View Full 10 Week Syllabus

Apply NOW For Pharmaceutical Facility Design

100% Privacy Guaranteed

This Course is For You If;

  • You work in or are responsible for making sure the cleanroom and utilities are sterile and safe.

  • You need an in-depth program on how the systems that underpin aseptic/sterile processing are designed and run.
  • You are responsible for planning the personnel and material flows and pressure profiles to prevent cross-contamination in sterile manufacturing environments.

And..

  • You want end-of-week progress checks and follow by us to MAKE SURE you finish the course.

  • Delivered Online you can keep working and still study without wasting your time or money or training budget on hotel or travel junkets.

Air and Water Systems

Learn about the systems that underpin aseptic/sterile processing.

Instrumentation and Process Control Design

Design for the generation and distribution of clean utility systems.

Cleanroom Layout

Design cleanroom layout & environmental controls pressure profiles.

Calculate the Mass Balance

Conduct site master planning for a new or modified manufacturing facility.

View Full 10 Week Syllabus

Our learners work for the world’s biggest pharma and medical device companies

Pfizer Logo

Abbott Logo

Novartis Logo

Lilly Logo

Roche Logo

Amgen Logo

Sanofi Logo

GSK Logo

See Pricing

Entry Requirements

  • You have worked in a GMP Regulated Pharmaceutical or Medical Device manufacturing environment.

What Does the Online Classroom Look Like?

Pharmaceutical Facility Design Course

We use one centralized platform where you can log into your classroom. There you can get assignments, interact with faculty and peers, reply to message boards, and more.

Each week, you’ll complete a series of videos, quizzes, interactive activities and projects through our online platform, available to access 24/7.
We release only one week’s worth of material at a time and then MANUALLY check your activity logs weekly to make sure that you’re managing to keep up with your workload. This helps us to spot any potential issues early. And you’ll have a dedicated course leader who will follow up with you if it looks like you’re starting to fall behind.
Your working schedules are unpredictable so we offer flexible delivery. Slow down, speed up or pause the delivery of the course.

See Pricing

Hear From People Who’ve Taken This Course
Pharmaceutical Facility Design

John Ryan

“The course content material is concise and interesting”

“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

Ronan Balfe

“I would have no hesitation in recommending these courses”

“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

Edel Harkins

“Highly recommended to anyone who has been out of the industry for a period of time”

“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

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.”

Success Stories From Facebook

IQ OQ PQ testimonial by Denissa Benjamin
IQ OQ PQ testimonial by John Redmond
GetReskilled testimonial by Bill Mclean
IQ OQ PQ testimonial by Brian OReilly
GetReskilled Success Stories From Facebook
IQ OQ PQ testimonial by Jason O Driscoll
IQ OQ PQ testimonial by Pat Kyne
IQ OQ PQ testimonial by Bisoye Areogun

Delivered by an Industry Expert

Dr.Joe Brady Lecturer at GetTeskilled

Dr. Joe Brady

Full-Time Validation Lead
Lecturer, Technological University Dublin, Ireland
Senior Associate, GetReskilled

Dr. Joe Brady is full-time practicing Validation Lead and an assistant lecturer with Technological University Dublin (TU Dublin), 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 twenty years of project experience in the pharmaceutical, biopharmaceutical and medical device industries in Ireland, Singapore, China, The Netherlands, France and the USA.

See Pricing

Your 10-Week Class Schedule

Your Class Director will check your study logs and only will release subsequent week’s materials to you if you have been logging in for more than 10 hours per week.

And he or she will proactively follow up with you to keep you on track.

Download Brochure

  • 1.1 Manufacturing Logistics Calculations
    In this lesson, we learn how to determine the size and capacity of primary processing equipment based on patient dosage requirements and the number of potential patients.
  • 1.2 Process Flow Diagram (PFD)
  • 1.3 Controlling Air Quality
    In this lesson, we take our first look at an air handling unit (AHU) and describe its functions.
  • 1.4 Heating, Ventilation, and Air Conditioning (HVAC) Systems
    In this lesson, we take a look at an overall heating and ventilation control (HVAC) system and explain its primary attributes.
  • 1.5 Basic Biopharmaceutical Unit Operations
    • 1-5-1 In this presentation we look at the basic biopharmaceutical unit operations that make up a typical drug substance manufacturing operation.
    • 1-5-2 In this presentation we look at the basic biopharmaceutical unit operations that make up a typical drug product formulation/fill-finish and packaging/labeling manufacturing operation
  • 1.6 Pharmacopeia Grade Waters
  • 1.7 Process Support and Utilities
    In this lesson, we take a look at the clean utilities requirements for a biopharmaceutical drug substance manufacturing process.
  • 1.8 Introduction to ISO 9001:2008
    This lesson is about the key requirements of a quality management system.
  • 1.9 Typical GMP list for drug substance
    This presentation explores the content of ICH Q7 “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients”.
  • 1.10 Operational Activities
    In this lesson, we take a look at how to maintain a critical computerized system in a state of operational control using standard procedures.
  • 1.11 GMP for Personnel
  • 1.12 Quality Systems Approach to Pharmaceutical cGMP Regulations – The Quality Systems Mode
    In this lesson, we describe a quality system model in accordance with management responsibilities, resources, manufacturing operations and evaluation activities.
  • 1.13 Maintenance: Good and Best Practices
    In this lesson, we describe basic and good practices associated with maintenance in a regulated environment.

  • 2.1 Project Lifecycle for New and Modified Facilities
    In this lesson, we describe the typical phases of a project lifecycle: conceptual design, tender contract analysis, basic engineering, detailed design, and project realization.
  • 2.2 Plant Layout 
    In these presentations, we explore the vertical distribution of process equipment for a bulk process building, the horizontal layout for a bulk process building, and an entire site layout for an integrated biopharmaceutical manufacturing site.
  • 2.3 Zoned Air-Conditioning Systems
    In this presentation, we look at a practical example where a HVAC system can be dynamically operated to control the temperature of a room (space
  • 2.4 Isolator Technology 
    In this lesson, we explain the principals behind the use of ‘isolators’ and Restricted Access Barrier Systems (RABs) for critical ‘open processing’ operation
  • 2.5 Cell Breakage
    In this lesson, we describe a mechanism for bacterial cell disruption for the recovery of intracellular products.
  • 2.6 Purified Water (PUW) Generation, Storage and Distribution 
    In these presentations, we look at methodologies to generate, store and distribute pharmacopeia grade purified water (PUW).
  • 2.7 Clean Room and Clean Air Device monitoring 
  • 2.8 Good Engineering Practices Procedures
    In this presentation, we will develop an understanding of good engineering practices, and learn about some various organizations that produce them.
  • 2.9 GMPs for Buildings and Facilities 
  • 2.10 Quality Systems Approach to cGMP Regulations – Management Responsibilities
    In this lesson, we outline management’s role in the design, implementation, and management of the quality system.
  • 2.11 Maintenance Program
    In this lesson, we describe the key aspects of a typical maintenance program.

  • 3.1 Conceptual Design – Part-1
    In this lesson, we begin to explore a quantified effort in how to size, shape, program and cost an investment.
  • 3.2 HVAC Requirements for Non-Sterile API Manufacturing
    In this lesson, we look at how to use airflow direction as a means of a containment barrier between operational areas in a non-sterile multi-product active pharmaceutical ingredient (API) manufacturing facility.
  • 3.3 Plant Automation
    This lesson is an introduction to conventional process control using one-way digital and analog signals
  • 3.4 Plant Steam
    In this lesson, we describe a process for generating and distributing plant steam to various processes within a manufacturing facility, and also describe how to manage any resultant condensate.
  • 3.5 Clean Steam Generators 
    The objective of this lesson is to demonstrate how we produce clean steam using ‘Single-Effect Distillation’ ‘Multiple-Effect Distillation
  • 3.6 Steam Sterilization in Place
    In these presentations, we look at the mechanism behind the sterilization of process equipment using saturated steam.
  • 3.7 GMPs for Process Equipment 
  • 3.8 Quality Systems – Resources
    In this lesson, we describe what resources need to be allocated for a quality system and operational activities.

  • 4.1 Conceptual Design – Part-2
    This lesson describes what influences the layout of a facility in terms of Layers, Preliminary Layout, Process Layouts, Media and Buffer Preparation, Clean Utilities and CIP, Access Corridors, Warehouse / Material Movements, Personnel Movements, Decisions on Height, Air Handling, General Utilities, Electrical, Controls & Automation, Finishes, Structural / Civil, Cost Estimate, and Schedule.
  • 4.2 Air Flow Patterns 
    In these presentations, we look at laminar air-flow patterns in the context of filling open vessels aseptically, and at the configuration and operation of both a laminar flow booth and a laminar flow cabinet typically found in the biopharmaceutical industry.
  • 4.3 Cleanroom Layout 
    In this lesson, we take a high-level look at a common cleanroom configuration and discuss items such as airflow direction, filter arrangements, cleanroom garments, and personnel and material flows. Another objective of this lesson is to also gain an understanding of personnel and material flows in a controlled airflow environment designed to contain high potency chemicals.
  • 4.4 Filter Ratings 
    In these presentations, we look at the particle retention efficiencies of air filters of various grades rated in accordance with European normalisation standards EN779 and EN1822. We also look at the particle arrestance efficiency of air filters of various grades rated in accordance with the ASHRAE standard 52-2 ‘Minimum Efficiency Reporting Value (MERV Rating)’.
  • 4.5 Logic Gates Functions and PLC 
  • 4.6 WFI Storage and Distribution
    In this lesson, we take a look at a process for the storage and distribution of pharmacopeia grade water for injection (WFI) and how to maintain its specification
  • 4.7 Good Engineering Practices Procedures 
  • 4.8 Quality systems Approach- Manufacturing
    In this lesson we describe Manufacturing’s responsibilities for (a) designing, developing, and documenting product and processes, (b) examining inputs, (c) performing and monitoring operations, and (d) addressing nonconformities.
  • 4.9 Maintenance- Work Execution
    In this lesson we describe the following Maintenance tasks and activities: (a) work request, (b) work order management, (c) information requirements for work orders, and (d) performance measurement.

  • 5.1 Site Master Planning – Part-I
    In this lesson, we take our first look at a site master planning based on planning rationale, assumptions, prerequisites, typical bulk production unit, site scope, flexibility, expandability, & future-proofing, determining size requirements, sizing & shaping, and broad rules
  • 5.2 Classification of Clean Areas – Vial Filling 
    In these presentations, we look at: (1) how to classify areas for aseptic operations, (2) typical configurations of air handling units (AHU’s), terminal filters, zone air-inlets and -exhausts to support various classified environments, (3) filter arrangements in air handling units and in their supply air ducting, (4) particles limits associated with various classified air environments, and (5) viable microbial limits, measured as Colony Forming Units (CFU), associated with various classified air environments.
  • 5.3 Area Classification Protection
    In this lesson, we observe a range of airlock configurations typically used in combination safety under operational conditions to maintain the specification of critical environmental zones, such as those used in open processing, that have a major impact on product quality and patient.
  • 5.4 Compress Air and Pneumatics
  • 5.5 Aseptic Filling 
    In this lesson, we describe the process equipment for the filling of medicinal vials aseptically in the sequence of washing, dehydrogenation, filling and their subsequent inspection.
  • 5.6 Cleanroom Gowning<