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

An injection bypasses all of your body’s natural defences. So 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. Core content developed in consultation with the industry including Pfizer and MSD.

Learn the air, water and steam systems that underpin aseptic/sterile processing
Conduct site master planning and cleanrooom design
Application Deadline: Wednesday 27th November

Approx. 150 hours to complete
Study Online part-time 15hrs/week for 10 weeks or choose a faster/slower schedule
Dedicated course leader who’ll check your progress at the end of every week and follow up with you to help you finish the course
Join 1320 Learners

Apply NOW to Learn the Systems that Underpin Aseptic/Sterile Processing

End-of-week progress checks and follow-up by us to MAKE SURE you or your team finish the course.

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

Learn the air, water and steam systems that underpin aseptic/sterile processing
Conduct site master planning and cleanrooom design
Application Deadline: Wednesday 27th November

Approx. 150 hours to complete
Study Online part-time 15hrs/week for 10 weeks or choose a faster/slower schedule
Dedicated course leader who’ll check your progress at the end of every week and follow up with you to help you finish the course
Join 1320 Learners

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

See Course Price

Apply NOW to Learn the Systems that Underpin Aseptic/Sterile Processing

End-of-week progress checks and follow-up by us to MAKE SURE you or your team finish the 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.

Enroll in this course to learn…

Key manufacturing technologies – such as organic chemical synthesis, biopharmaceutical manufacturing, tablet manufacturing and aseptic & sterile manufacturing
Purified water generation – storage and distribution that underpin aseptic/sterile processing
Clean steam – water for injection, storage and distribution that underpin aseptic/sterile processing.
Instrumentation process control design – for the generation and distribution of clean utility systems.
Cleanroom layout design – layout and classification along with the environmental controls pressure profiles
Aseptic processing – lyophilization and how vials are filled in an aseptic environment
Quality systems – for cleanrooms for both EMA and FDA guidance on aseptic processing.

You’ll produce a number of deliverables throughout the program including…

Complete 8-question booklets (one for every week’s worth of content) which will summarise what you have learnt for the week and ensure you retain and understand the information.
Complete an end of module assignment to include the following:
- Sketch and label process flow diagrams illustrating typical biopharmaceutical unit operations for the sequential manufacture of both drug substances and drug products.
- Describe process support and utility systems encountered on a typical biopharmaceutical facility
- Sketch and describe the configuration of a hypothetical cleanroom environment for aseptic processing (e.g. for vial filling operations).
- Describe the similarities and differences between pharmacopoeia grade purified water (PUW) and water for injection (WFI).

And take the following skills and knowledge back to work…

You’ll have a strong foundation in how safe medicines and medical devices are made in a GMP regulated manufacturing environment.
You’ll understand the air, clean water and steam systems that underpin aseptic/sterile processing.
You’ll understand cleanroom layout design, layout and classification and the environmental controls pressure profiles
You’ll have the technical knowledge and understanding of the quality culture necessary to work in this environment

View Full 10 Week Syllabus

Minimum Entry Requirements

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

Hear From People Who’ve Taken This Course

Renato Chato

“This course was very informative and could greatly enhance our knowledge and understanding on Pharma Manufacturing practices (GMP, GDP, etc.). The training experience was great and details were clear. Keep it up, guys!”

Michael Cheong Yim Poh

“Once you tune in your mind set to studying online, it’s a great way to learn as you manage the pace yourself.”

Delivered by an Industry Expert

Dr. Joe Brady

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

Dr. Joe Brady is a 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 programs ranging from MSc, MEngSc. BSc, to Certificate level, for a range of academic institutions.

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 Singapore, China, Ireland, The Netherlands, Belgium, France, and the USA.

Meet Your Online Classroom Support Team

When you learn at GetReskilled, you can always rely on an in-house team of experts to provide guidance and support, whenever you need it.

Course Leaders

Your Course Leaders will onboard you on the program, and help keep you motivated throughout the course.

Course Coordinators

Your CC’s are here to provide you with answers, tips, and are going to check your progress weekly to keep you on track and will reach out to you by email or even by phone if you fall behind!

See Course Price

If you’re spending money on an education program, make sure you choose one you’ll finish!

With every GetReskilled ONLINE program;

We use one centralized platform (Moodle) where you can log into your classroom anytime. Each week, you’ll watch videos and complete a series of quizzes, tests, interactive activities, and projects. The course materials are available 24/7 and nothing requires you to be online at a specific day or time. i.e there are NO ZOOM classes and NO WEBINARS! Study anywhere, anytime, for example after the kids have gone to bed or on the weekend.
Your working schedules are unpredictable so we offer flexible delivery. Slow down, speed up or pause the delivery of the program.
We release only one week’s worth of material at a time and then MANUALLY check your activity logs at the end of every week to make sure that you are keeping up with your work.
You’ll have a dedicated course leader who will email or telephone you if it looks like you’re starting to fall behind. They will work with you to develop a study plan to get you back on schedule and finish the course.

This all helps us to spot any potential issues early and helps you completely finish the program.

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.

Week 1 – Controlling Air Quality and Clean Utilities

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.

Week 2 – Purified Water Generation and Distribution

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.

Week 3 – Clean Steam and Sterilization

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.

Week 4 – Controlling Material and Personnel flows

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.

Week 5 – Aseptic Processing and Vial Filling

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
In this lesson, we describe clothing that will minimize dispersion from skin and clothing for personnel working within a cleanroom environment
5.7 Aseptic Processing
In these presentations, we look at various manual and automated processes and facility layouts for vial filling operations.
5.8 Cleanroom Monitoring – Physical Tests
In this lesson, we discuss typical physical tests to monitor cleanroom environments: non-viable particle counts, pressure differentials, airflow velocity, air change rate, and filter integrity testing.
5.9 Quality System – Evaluation Activities
5.10 Maintenance Management
This lesson describes the processes and controls used in the delivery of maintenance services and work execution.

Week 6 – Controlling Cleanrooms and Automation

6.1 Site Master Planning – Part-II
We continue in this lesson exploring the configuration philosophy for a site specifically layering, configuration options, fermentation/bioreactor, media and buffer preparation. We also look at the shaping and sizing options for fermentation, media preparation, buffer preparation, downstream processing, process and general utilities, buildings, and expansion.
6.2 Open Versus Closed Processing
6.3 Facility Layout Concept
6.4 Blow/Fill/Seal Technology
6.5 PLC Programming
In this lesson, we describe how to program a PLC to automate a machine using ladder logic diagrams.
6.6 PLC Program Case Studies
6.7 Cleanroom Monitoring – Microbiological Tests
In this lesson, we look at a range of typical microbiological measurements to monitor a cleanroom environment for conformance to specifications.
6.8 Cleanroom Monitoring – Cleanrooms Cleaning Procedures
6.9 Terminally Sterilised Products
6.10 EU Guidelines on Cleanroom Aseptic Preparation

Week 7 – Quality Systems for Cleanrooms

7.1 HVAC Critical Parameters for Sterile and Non-Sterile Manufacturing
7.2 Batch Process Control
In this lesson, we discuss the ISA-88.01 modularization software standard for segmenting a process into physical entities, and into procedural models for instructional recipes. The physical model is used to describe equipment, and the procedural model used to describe recipes (process sequencing).
7.3 Nitrogen Supply and Distribution
7.4 Environmental Monitoring Program
In this lesson, we describe how to monitor a cleanroom environment in order to identify actual and potential sources of contamination using both physical and microbiological techniques.
7.5 ICH Q10 – Pharmaceutical Quality System
This lesson explains the concept of ‘continual improvement’ as part of a company’s quality management system and describes an effective corrective action process and a preventive action process (CAPA). It also gives details on the product-lifecycle for a pharmaceutical product and describes the monitoring of process performance and product quality.
7.6 FDA Guidance on Aseptic Processing

Week 8 – Construction Lifecycle for New and Modified Facilities

8.1 Construction Lifecycle
In the first class for construction lifecycle, we explore the following: choosing a construction type, substructure, options for super-structure, internal building fabric, mechanical installation, electrical & instrumentation, construction sequence for new build, constructability, construction management, construction safety, construction costs, schedule, and quality management. In the second video, we look at the contents of clean utility piping test packs. In the third video we look at modular construction and sustainable construction.
8.2 Software Functional Block Diagram (FBD)
8.3 ASTM E 2500
In this lesson, we review the ASTM International standard E 2500 – 07 ‘Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment’.

Weeks 9 & 10 - Competency Based Assessment

The end of module assessment is a competency based open book exam where you will need to answer 8 essay style questions. Each essay will require about half a page to one page to answer. Your answer will be assessed as either competent or not yet competent. In addition, you will also have a 15 minute oral interview with our Subject Matter Experts.

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

Accredited by the WDA under the WSQ Program

You will receive an end of course certificate from DPS Education subject to the following criteria;

The submission of all assessments and the end of module assignment.

Show Off Your New Skills: Get a Certificate of Completion

Complete all assessments and the end of module written assignment to receive a Certificate of Award in “Principles of Pharmaceutical Facility Design“.

Add details of your certificate to your CV/Resume or your LinkedIn profile.

Pharmaceutical Facility Design Certificate

Frequently Asked Questions

How do you keep track of my progress on the course?

We release only one week’s worth of material at a time and then 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. There is a “Progress Bar “on your course which is helpful to you and us to know how you are doing.

You have a dedicated course leader who will follow up with you if it looks like you’re starting to fall behind. She’ll also be in touch weekly to let you know when new content is open for you.

Is this program delivered online?

Yes, this program is delivered fully online.

What does a typical week look like?

Each week of online content typically includes 6-10 topics.

Each topic includes:

A set of course notes – these provide additional depth to the video content.
Warm-up self-assessment question – to recap or activate any relevant prior learning.
A video – these are typically 5-10 minutes long and deliver 80% of the course content.
Post video self-assessment questions to check how well you can recall this new material from memory. If you can’t answer these questions, you should revisit that topic’s learning materials.
Any follow up assessments or assignments.

How many hours a week must I do for the course?

Most students report between 8-14 hours per week.

Do I need to be online all the time?

No you don’t. The online classroom is open 24 hours a day so you do not have to login at any particular time. We will give you a Username and Password on the day the program starts and this allows you 24 hours a day access.

Can I pause the class if I get to busy at work or because of family commitments?

Yes.

Can I take this course at a faster pace?

Yes, you can speed up or slow down the rate of delivery to suit your requirements. The most important thing is communication between you and your course coordinator. If you are taking a break or are busy at work and do not have time to study you need to tell her or him. Similarly, if you want to study at a faster rate, then just email in good time and ask for more course content.

Will I have access to the materials after the course is finished?

Yes for 6 months.

Is this course relevant to both pharmaceutical and medical device manufacturing industries?

Yes, this course is relevant to both the pharmaceutical and medical device industries.

Price

S$1,299/month

For 3 Months

S$3,499 in Advance

Save S$398

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Application Deadline: Wednesday 27th November

Course Starts: 4th December

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Call Geraldine: +(65) 6513 9500

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