Conversion Course into Clean Utilities Roles in Pharma

Do you work in Semiconductor Manufacturing in Mechanical, Maintenance, Industrial, Manufacturing or Facility Engineering?

Cross-Train ONLINE for Engineering Roles in the Pharma Manufacturing Industry in 18-Weeks Quickly fill in the gaps in your knowledge to successfully move into mechanical, plant, maintenance, or facility engineering roles within the pharmaceutical & medical device industry from a different industry. Core content developed in consultation with the industry including Pfizer and MSD.

  • Estimated salaries $47,000 – $85,000 plus overtime, bonuses and allowances. (Based on US job data)

  • Estimated salaries €39,000 – €80,000 plus overtime, bonuses and allowances. (Based on Irish job data)

  • Learn the air, water and steam systems that underpin aseptic/sterile processing

  • Learn how safe medicines are made using GMPs

  • Application Deadline: Wednesday 18th December
  • Study Part-Time Online
  • Course materials are available 24/7. There are NO ZOOM classes!
  • 12 hrs/week for 18 weeks or choose a faster/slower schedule
  • Join 1290 Learners

NOTE: You’ll get a dedicated course leader who’ll work with you to develop a weekly study schedule, then check your progress every Friday and follow up with you to help you finish the course.

Conversion Course into Engineering Roles in Pharma
Apply NOW and cross-train for mechanical, plant, maintenance, or facility engineering roles →

Contact Details For This Course

Geraldine Creaner

+353 (0)21 240 9016

+1 (617) 901 9268

+44 078 0237 0554

Course Price →

Conversion Course into Clean Utilities Roles in Pharma

Do you work in Semiconductor Manufacturing in Mechanical, Maintenance, Industrial, Manufacturing or Facility Engineering?

Cross-Train ONLINE for Engineering Roles in the Pharma Manufacturing Industry in 18-Weeks Quickly fill in the gaps in your knowledge to successfully move into mechanical, plant, maintenance, or facility engineering roles within the pharmaceutical & medical device industry from a different industry. Core content developed in consultation with the industry including Pfizer and MSD.

Conversion Course into Engineering Roles in Pharma

  • Estimated salaries $47,000 – $85,000 plus overtime, bonuses and allowances. (Based on US job data)

  • Estimated salaries €39,000 – €80,000 plus overtime, bonuses and allowances. (Based on Irish job data)

  • Learn the air, water and steam systems that underpin aseptic/sterile processing

  • Learn how safe medicines are made using GMPs

  • Application Deadline: Wednesday 18th December

  • Study Part-Time Online
  • Course materials are available 24/7. There are NO ZOOM classes!
  • 12 hrs/week for 18 weeks or choose a faster/slower schedule
  • Join 1290 Learners

NOTE: You’ll get a dedicated course leader who’ll work with you to develop a weekly study schedule, then check your progress every Friday and follow up with you to help you finish the course.

Course Price →

Apply NOW and Cross-Train for mechanical, plant, maintenance, or facility engineering roles →

Contact Details For This Course

Geraldine Creaner

+353 (0)21 240 9016

+44 078 0237 0554

+1 (617) 901 9268

Core content developed on a pharma engineering project

This program was developed on-site by a team of senior chemical engineers, process engineers, and biochemists working within an engineering consultancy during the construction of a new pharmaceutical plant to cross-train its own engineers and technicians for mechanical, plant, maintenance, or facility engineering roles.

You will write a 3,000-word technical report about a new aseptic manufacturing facility

You will write a 3,000-word technical report to present to senior management about a new aseptic pharmaceutical manufacturing plant. Your report will help management make critical decisions about the plant design. The report should cover the 5 key sections:

  • Production Logistics
  • Process Flow
  • Site Master Plan
  • Cleanroom Layout
  • Utility Support Systems

Our chemical engineers will give you written feedback on your report.

Minimum Entry Requirements

This program is highly specialized so you MUST have the following:

Ph.D., Masters, Degree, or Diploma in:

  • Mechanical Engineer/Technician
  • Maintenance Engineer/Technician
  • Facilities Engineer/Technician
  • Plant Engineer/Technician
  • Production Engineer
  • Manufacturing Engineer
  • Industrial Engineer
  • Graduate Engineer of any of the above

AND YOU MUST

  • currently work in the field
    OR
  • have worked or graduated in this field within the last 2 years

If not, check out our University Certificate in eBioPharmaChem

ebiopharmachem

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

Pfizer Logo

AstraZenega Logo

Novartis Logo

GSK Logo

Lilly Logo

Abbott Logo

MSD Logo

Boston Scientific Logo

Medtronic Logo

Takeda Logo

Abbvie Logo

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

Pfizer Logo

AstraZenega Logo

Novartis Logo

Lilly Logo

Roche Logo

Amgen Logo

Sanofi Logo

GSK Logo

What kind of engineering roles in pharma could I retrain for?

Here are some typical job titles we often see advertised and that you could apply for (depending on your previous experience)

  • Maintenance Engineer
  • Plant Engineer
  • Maintenance Systems Lead – ownership of all preventative and corrective works on plant utilities and equipment.
  • Maintenance Planner – the focus is on developing the company asset maintenance program and strategy.
  • Lead Utilities Engineer – manage capital projects from inception to delivery and ensure plant availability is maximised.
  • Clean Utilities Engineer – ownership of clean utility systems
  • Facilities Engineer
  • Mechanical Engineering
  • Quality/Environmental Engineering
  • Manufacturing/Production Engineering (Medical Device Manufacturing or Combination Product Manufacturing)
  • Validation Engineering (with our add-on validation program)

I already have an engineering degree. So why take this course?

Your skills are a great foundation for engineering roles within this sector. But you need more..

You need to understand the industry regulations, the different regulatory standards (US, European, World Health Organization, etc), work practices, approaches to risk management, data integrity approaches, and industry protocols that are critical in the manufacture of safe medicines.

You also need to understand how the air, water and steam systems that underpin and support aseptic/sterile processing and cleanroom manufacturing work.

Enroll in this course to learn…

  • Introduction –  to pharmaceutical, (bio)pharmaceutical manufacturing in a GMP (Good Manufacturing Practice) regulated environment, quality systems vs regulation vs validation
  • Industry regulations and guidelines –  including, FDA GMPs for the United States, EMA GMPs for Europen Union, ICH, and PICs GMP regulation
  • FDA medical device rules – medical device regulations & guidelines
  • GMPs vs ISO 9001:2015 – what’s the difference and why we use both
  • Process validation and documentation –  design and verification of manufacturing systems
  • Supporting technologies  – such as purified water generation, storage & distribution, clean steam, water for injection, storage and distribution
  • Introduction to quality risk management (QRM)  – and the importance of risk management and the basic steps involved in its application
  • 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.
  • Professional writing skills program – This will guide you through the assignment writing process and equip you with the written communication skills you need for working in the industry

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

  • Complete 2 Quality Risk Management workshops on:
    • Fault Tree Analysis (FTA)
    • Failure Mode Effect Analysis (FMEA)
  • Complete 14-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 a 3,000-word report to give senior management the information they need to make informed decisions about building a new aseptic manufacturing facility.
  • Complete a 1,200-word end-of-module written technical report on cGMPS.

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 18 Week Syllabus

Course Price →

Hear from people who’ve taken this course

Pharmaceutical Degree

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 Degree

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 Degree

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!”

Read over 55 reviews and graduate success stories.

Your 18-Week Class Schedule

Module 1 – Manufacturing Safe Medicines (Weeks 1-5)

Week 1 – Industry Regulations and Guidelines

  • Topic-1 Finished Medicinal Products
    In this lesson, we learn about medical products and the various ways drug products are administered.
  • Topic-2 Focus on Patient Safety and Product Quality
    In this lesson, we will develop a deeper understanding of the importance of patient safety and product quality for medicines and medical devices.
  • Topic-3 ISO9001:2008
    This lesson is about the key requirements of a quality management system.
  • Topic -4 Product Quality and Current Good Manufacturing Practices [ cGMP ]
    In this lesson, we learn how to scientifically define product quality. This lesson also gives an insight into the high-level principles of current good manufacturing practices (cGMP).
  • Topic -5 API Regulatory Guidelines
    In this lesson, we describe the characteristics of a GMP that can be followed to manufacture an API.
  • Topic-6 ISO-9001 ‘Continual Improvement’ & 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.
  • Topic-7 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.
  • Topic-8 FDAMedicalDeviceRules-CFR820
    In this lesson, we look at how the FDA classifies medical devices and explore the basis of that classification system.
  • Topic -9 Medical Device Regulations and Guidelines – ISO 13485 / CFR 820
    In this lesson, we look at some GMP regulatory and ISO guidance documents that are associated with the manufacture of medical devices.

Deliverables

  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

  • Topic-1 Process Validation
    In this lesson, we will learn about the various definitions of ‘validation’, as well as for ‘commissioning’, ‘qualification’ and ‘verification.
  • Topic-2 ASTME2500 – Standard Guide for Specification, Design and Verification
    In this lesson, we will describe a specification, design, and verification approach for equipment systems associated with the pharmaceutical, biopharmaceutical and medical device industries.
  • Topic-3 PQ,OQ and IQ
    In this lesson, we are going to define the terms installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ), and we will also list what typical project design documents are required to prepare such testing protocols.
  • Topic-4 Cleaning Validation
    This class takes a high-level look at a typical cleaning validation sequence. It looks at how to determine the basis for quantification limits and explains how to determine cleanliness levels on the basis of the analytical testing of representative samples. Sampling is described in terms of sampling-equipment, sampling -locations, and sampling –procedures.
  • Topic-5 Introduction to Quality Risk Management (QRM)
    In this lesson, we will develop an understanding of the history and the crucial importance of risk management as well as the basic steps involved in its application.
  • Topic -6 Fault Tree Analysis (FTA) – step 4 ‘Workshop’ exercise
    In this lesson, we learn about the risk management tool ‘Fault Tree Analysis’ and see an example of where and how we can use it.
  • Topic -7 Failure Mode, Effects (and Criticality) Analysis (FMEA / FMEAC) – Step 4 ‘Workshop’ exercise
    This presentation shows an example of the main steps in performing a ‘Failure Mode, Effects Analysis’ (FMEA) and describes how this risk management technique summarizes the important modes of (a) failure, (b) factors causing these failures, and (c) the likely effects of these failures.
  • Topic-8 Documenting the Quality Risk Management Process
    In this lesson, we take a practical look at managing a complete risk management process in terms of identifying risk, analyzing risk, evaluating risk, and controlling risk.

Deliverables

  • Complete two workshops on Fault Tree Analysis (FTA) and Failure Mode Effect Analysis (FMEA)
  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

  • Topic-1 Batch Organic Chemical Synthesis
    In this lesson, we describe the typical equipment and process stages of the manufacture of active pharmaceutical ingredients (API) using batch organic chemistry synthesis
  • Topic-2 Biopharmaceuticals Manufacturing, Upstream, Fermentation
    This lesson describes a conventional biotechnological process and introduces the following process sequences:

    • Stage-I – Upstream Processing
    • Stage-II – Fermentation / Bio-reaction
    • Stage-III – Downstream Processing
  • Topic -3 Tablet Manufacturing
    In this lesson, we will explore the critical process parameters and quality attributes associated with the manufacture of medicinal tablets.
  • Topic -4 Aseptic & Sterile Manufacturing
    In this lesson, we look at critical process parameters and quality attributes associated with aseptic processing and terminal sterilization products for parenteral products.

Deliverables

  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

  • Topic-1 Purified Water (PUW) Generation, Storage and Distribution
    In these presentations we look at methodologies to generate, store and distribute pharmacopeia grade purified water (PUW).
  • Topic -2 Clean Steam Generators
    The objective of this lesson is to demonstrate how we produce clean steam using ‘Single-Effect Distillation’ ‘Multiple-Effect Distillation
  • Topic -3 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
  • Topic -4 Engineering Aspects of Cleaning, and Cleaning Equipment
    This class discusses how to clean and decontaminate surfaces using CIP (clean-in-place), agitated Immersion, static Immersion (Soaking), and automated parts washers, ultrasonic cleaning, high-pressure spraying, and manual cleaning
  • Topic-5 Chemistry Aspects of Cleaning
    This lesson explores chemistry aspects of cleaning in terms of solubility, solubilisation, emulsification, dispersion, wetting, hydrolysis, oxidation and physical removal.
  • Topic -6 Steam Sterilization in Place
    In this lesson, we look at the mechanism behind sterilization of process equipment using saturated steam.
  • Topic-7 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.
  • Topic-8 Cleanroom Layout–2 videos
    In these presentations, 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.
  • Topic -9 Area Classification Protection
    In this lesson, we observe a range of airlock configurations typically used in combination with 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.
  • Topic -10 Cleanroom Gowning
    In this lesson, we describe clothing that will minimize dispersion from skin and clothing for personnel working within a cleanroom environment
  • Topic -11 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.

Deliverables

  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

Write a 4-5 page essay, which you could present at a job interview to clearly demonstrate your Technical Knowledge and Understanding of the Quality Culture necessary to work in a GMP regulated manufacturing environment. It will confirm your understanding of how to Manufacture Safe Medicines and Medical Devices in a GMP regulated environment and will include the following topics:

  • The key requirements of a quality management system
  • The manufacturing responsibilities for quality systems
  • The cleaning validation sequence and how to determine cleanliness levels
  • The documentation of a complete risk management process in terms of identify risk, analyzing risk, evaluating risk and controlling risk.
  • The typical equipment and process stages used in the manufacture of active pharmaceutical ingredients
  • The critical process parameters and quality attributes associated with the manufacture of tablets.
  • The generation, storage and distribution of pharmacopeia grade Purified Water (PUW).
  • The common cleanroom configuration and airflow direction that governs personnel and material flows in a biopharmaceutical manufacturing environment

Module 2 – Pharmaceutical Facility Design (Weeks 6-18)

This module was developed in consultation with the pharma industry including Pfizer and MSD.

Week 6 – Controlling Air Quality and Clean Utilities Part 1

  • 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/labelling 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.

Deliverables

  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

  • 2.1 Introduction to ISO 9001:2008 and 2015
    This lesson is about the key requirements of a quality management system.
  • 2.2 Typical GMP list for drug substance
    This lesson explores the content of ICH Q7 “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients”.
  • 2.3 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.
  • 2.4 GMP for Personnel
  • 2.5 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.
  • 2.6 Maintenance: Good and Best Practices
    In this lesson, we describe basic and good practices associated with maintenance in a regulated environment.

Deliverables

  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

  • 3.1 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.
  • 3.2 Plant Layout
    In this lesson, 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.
  • 3.3 Zoned Air-Conditioning Systems
    In this lesson, we look at a practical example where a HVAC system can be dynamically operated to control the temperature of a room (space).
  • 3.4 Isolator Technology
    In this lesson, we explain the principles behind the use of ‘isolators’ and Restricted Access Barrier Systems (RABs) for critical ‘open processing’ operation.
  • 3.5 Cell Breakage
    In this lesson, we describe a mechanism for bacterial cell disruption for the recovery of intracellular products.

Deliverables

  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

  • 4.1 Purified Water (PUW) Generation, Storage and Distribution
    In these lessons, we look at methodologies to generate, store and distribute pharmacopeia grade purified water (PUW).
  • 4.2 Clean Room and Clean Air Device monitoring 
  • 4.3 Good Engineering Practices Procedures
    In this lesson, we will develop an understanding of good engineering practices, and learn about some various organizations that produce them.
  • 4.4 GMPs for Buildings and Facilities 
  • 4.5 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.
  • 4.6 Maintenance Program
    In this lesson, we describe the key aspects of a typical maintenance program.

Deliverables

  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

  • 5.1 Conceptual Design – Part-1
    In this lesson, we begin to explore a quantified effort in how to size, shape, program, and cost an investment.
  • 5.2 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.
  • 5.3 Plant Automation
    This lesson is an introduction to conventional process control using one-way digital and analogue signals.
  • 5.4 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.
  • 5.5 Clean Steam Generators
    The objective of this lesson is to demonstrate how we produce clean steam using ‘Single-Effect Distillation’ ‘Multiple-Effect Distillation. 
  • 5.6 Steam Sterilization in Place
    In these lessons, we look at the mechanism behind sterilization of process equipment using saturated steam.
  • 5.7 GMPs for Process Equipment 
  • 5.8 Quality Systems – Resources
    In this lesson, we describe what resources need to be allocated for a quality system and operational activities.

Deliverables

  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

  • 6.1 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.
  • 6.2 Air Flow Patterns 
    In these lessons, 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.
  • 6.3 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. 
  • 6.4 Filter Ratings
    In these lessons, 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)’.
  • 6.5 Logic Gates Functions and PLC 
  • 6.6 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.
  • 6.7 Good Engineering Practices Procedures
  • 6.8 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.
  • 6.9 Maintenance- Work Executions
    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.

Deliverables

  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

  • 7.1 Site Master Planning – Part-I
    In this lesson, we take our first look at 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.
  • 7.2 Classification of Clean Areas – Vial Filling 
    In these lessons, 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.
  • 7.3 Area Classification Protection
    In this lesson, we observe a range of airlock configurations typically used in combination 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. 
  • 7.4 Compress Air and Pneumatics 
  • 7.5 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.
  • 7.6 Cleanroom Gowning
    In this lesson, we describe clothing that will minimize dispersion from skin and clothing for personnel working within a cleanroom environment.
  • 7.7 Aseptic Processing 
    In these lessons, we look at various manual and automated processes and facility layouts for vial filling operations.
  • 7.8 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.
  • 7.9 Quality System – Evaluation Activities 
  • 7.10 Maintenance Management
    This lesson describes the processes and controls used in the delivery of maintenance services and work execution.

Deliverables

  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

  • 8.1 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.
  • 8.2 Open Versus Closed Processing  
  • 8.3 Facility Layout Concept 
  • 8.4 Blow/Fill/Seal Technology 
  • 8.5 PLC Programming
    In this lesson, we describe how to program a PLC to automate a machine using ladder logic diagrams.
  • 8.6 PLC Program Case Studies 
  • 8.7 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.
  • 8.8 Cleanroom Monitoring – Cleanrooms Cleaning Procedures 
  • 8.9 Terminally Sterilised Products 
  • 8.10 EU Guidelines on Cleanroom Aseptic Preparation 

Deliverables

  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

  • 9.1 HVAC Critical Parameters for Sterile and Non-Sterile Manufacturing 
  • 9.2 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).
  • 9.3 Nitrogen Supply and Distribution
  • 9.4 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.
  • 9.5 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.
  • 9.6 FDA Guidance on Aseptic Processing 

Deliverables

  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

  • 10.1 Construction Lifecycle
    In the first lesson 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 lesson, we look at the contents of clean utility piping test packs. In the third lesson, we look at modular construction and sustainable construction.
  • 10.2 Software Functional Block Diagram (FBD)
  • 10.3 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’.

Deliverables

  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

Complete a 3,000-word report to give senior management the information they need to make informed decisions about building a new aseptic manufacturing facility. The report should cover 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 in 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).

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

You will receive a Certificate of Award from GetReskilled for each module 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.

Delivered by an industry expert

Dr.Joe Brady Lecturer at GetTeskilled

Dr. Joe Brady

</