DT275 Student Handbook

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Student Handbook

Postgraduate Diploma/MSc Pharmaceutical and Chemical

Process Technology



Contents

Programme details

Aims and Objectives

Programme Structure

Overview of Modules

In-Course Assessment

Course journal list

Course management

Guidance to student



Welcome

On behalf of the Programme Committee I would like to welcome you onto this programme.

This programme is designed to provide you with the necessary knowledge and skills to

operate effectively in chemical and pharmaceutical production processes and to contribute

significantly to your continuing professional development in the chemical and

pharmaceutical sectors.

The programme is managed by the School of Chemical and Pharmaceutical Sciences,

Faculty of Science, DIT, Kevin St. and the full-time staff teaching on this programme are

from the School of Chemical and Pharmaceutical Sciences and the School of Control

Systems and Electrical Engineering.

The programme will take place in the Faculty of Science, DIT, Kevin St.

This course handbook is designed as a useful reference for you as you participate in this

programme. Further details can be found in the Programme Documentation Parts A/B.

Chairperson Programme Committee



Programme details

Staff

Membership of Programme Team.

Paul Ashall, Lecturer in Chemical and Pharmaceutical Technology

Hassan Ali, Lecturer in Chemical Technology

Gavin Duffy, Lecturer in Process Control and Separation Processes

Peter Kavanagh, Lecturer in Chemical Technology

Anne Greene, Lecturer in Process Validation and Pharmaceutical Technology

Claire McDonnell, Lecturer in Chemical Development

Fiona O’Sullivan, Lecturer in Process Validation and Pharmaceutical Technology

Membership of the Programme Committee

The proposed Programme Committee (subject to nomination by the Head of School) will

be as follows:

Dr. D. McCormack Head of School

Dr. M.B.Foley

Dr. H. Ali

Mr. P.Ashall Programme Director

Mr. Gavin Duffy

Student Rep.

Programme Tutors

P. Ashall, G. Duffy, H. Ali, C. McDonnell, A. Greene



Aims and Objectives

The overall aim of this programme is to provide education at postgraduate level in aspects

of chemical and pharmaceutical process and production technology which are of relevance

to scientists, engineers and other professions who operate in the chemical and

pharmaceutical industry and related sectors, particularly in the production, process and

chemical development areas.

General programme objectives include:

(i) To provide a programme which allows graduates to develop the necessary

knowledge and skills to integrate quickly into the industrial environment and tooperate effectively in production processes.

(ii) To present to the student a body of knowledge, practical, technical and theoretical,

that is relevant to the needs of industry in the area of chemical and pharmaceutical

process technology and related topics

(iii) To provide a unique opportunity for personnel already employed in industry to

obtain a highly relevant postgraduate qualification over two or more years on a

part-time basis

(iv) Provision of high quality industrially relevant education and training by experts

from academia and industry

(v) The teaching of proposed modules and related topics designed to enhance the

knowledge and skills of students in these areas

(vi) To provide a broad programme consistent with the graduate intake and programme

objectives

(vii) Provision of appropriate assessments and assignments to promote, reinforce and

test learning

(viii) To deliver modules and topics suitable for continuing professional development

(ix) To deliver a programme which will enable graduates to outline design requirements

for process plant and to work effectively with engineers and other professions as

part of a process/chemical development team



(x) To deliver a programme which will enable graduates to work effectively with

engineers and other professions in solving plant operating problems

(xi) To enhance the students ability to exploit work-based learning and self-directed

learning

(xii) To develop research skills

(xiii) To develop transferable (key professional) skills.



Programme Structure

The lecture programme is divided into twelve taught modules. Each module also

comprises of assessment elements such as written examinations, case studies, design

exercises, essays, laboratory practicals etc. The project is completed in Semester five of

the part time programme. In-course assignments will be in the form of laboratory practical

assignments, case studies, design exercises, individual and team assignments, problem sets

and essays. These assignments are designed to build upon, and give practical expression

to, the material covered in the lecture programme.

Programme delivery is by lectures, case studies, seminars, laboratory based practical

exercises and tutorials/problem solving sessions.

Students are expected to build on the framework of material delivered at lectures etc by

directed self-study from recommended textbooks, review articles and journals.

Programme Delivery Structure (part time programme)

Duration Lectures/wk

(ave.)

Semester 1 (Yr

1)

13 weeks 6 hours

Semester 2 (Yr

1)

13 weeks 6 hours

Semester 1 (Yr

2)

13 weeks 6 hours

Semester 2 (Yr

2)

13 weeks 6 hours

Semester 1(Yr 3) Project By arrangement with Programme Committee and Employer

The laboratory practical programme consists of a number of experiments (refer to module

descriptors). A laboratory manual will be issued to students. Students are required to

comply with laboratory safety rules.



List of Modules

Module Code Title

1 CPPT9001 Pharmaceutical processes – basic principles

2 CPPT9002 Heat transfer and fluids

3 CPPT9003 Mass transfer applications in pharmaceutical processes

4 CPPT9004 Reactor design and separation processes I

5 CPPT9005 Separation processes II

6 CPPT9006 Material handling and drying

7 CPPT9007 Process control

8 CPPT9008 Process utilities et al

9 CPPT9009 Process design and development

10 CPPT9010 Facility design and operation

11 CPPT9011 Management aspects of pharmaceutical production

12 CPPT9012 Regulatory aspects, GMP and process validation

13 CPPT9013 Project



Detailed Programme Structure

Module Delivery

Method

Student

Contact

Hours

Student Self

Learning

(hr)

Assessment

Mode

Total

Student

Workload

(hr)

ECTS

1CPPT

9001

Lecture 24 76 AssignmentWritten

examination

100 5

2

CPPT

9002

Lecture 24 76 Assignment

Written

examination

100 5

3

CPPT9003

Lecture 24 76 Assignment 100 5

4

CPPT9004


Writtenexamination

100 5

5CPPT

9005

Lecture 24 76 AssignmentWritten

examination

100 5

6

CPPT

9006


7

CPPT

9007


Written

examination

100 5

8CPPT9008


9CPPT

9009


10

CPPT

9010


11

CPPT

9011


12

CPPT9012


ProjectCPPT

9013

Industry/work Based

Thesis 600 30

TOTAL 1800 90



The current structure has 13 modules (12 taught modules and a project module). Modules

include a laboratory element and laboratory based practical work which will be assessed in-

course. Modules are assessed by assignment and written examination. Module 13 is

assessed by dissertation.

Module 13 comprises of an industrial/work based project.

The project allows the student the opportunity to undertake a detailed study of a topic

relevant to industry. Projects are normally performed at the place of employment. The

standard expected for the final body of work is appropriate for a taught Master's degree and

should include an amount of originality. The final report must be in a typed, bound form

with typical length of 15,000 to 20,000 words (not including appendices etc.).

Projects for part-time students are normally proposed by the student in consultation with

their employer.

All project proposals must include the aims and objectives of the project, the research

methodology and the expected outcomes.

Overview of Modules

The content of taught modules and topics/subjects may vary from time to time. The

syllabuses presented here are only a guide as to the subject material and content delivered

in the programme and the time allocated to particular topics.



Dublin Institute of Technology

Pre-

Requisite

Modules

code(s)

Co-

Requisite

Modules

code(s)

ECTS

Credits

Module

Code

Module Title

None CPPT9001-9012

5 CPPT9001 Pharmaceutical Processes

Module author: Gavin Duffy/Paul Ashall/Hassan Ali

Module Description:

This module introduces the student to chemical and pharmaceutical processes, the unit

operations they typically consist of and how mass and energy are accounted for on an

overall basis throughout a typical process.

Module aim

The module is aimed at those who have no prior knowledge of chemical and

pharmaceutical production processes. The objective of the module is to introduce the

student to the overall analysis of chemical and pharmaceutical processes by mass andenergy balance. A simple pharmaceutical process such as the production of aspirin is used

as a case study. The basic principles and techniques of mass and energy balances are

applied to this type of process.

Learning Outcomes:

On completion of this module the learner will be able to:

• Describe the fundamental principles of operation of chemical and pharmaceutical

processes

• Explain the principles of mass and energy balance

• Apply the techniques of mass and energy balance to chemical and pharmaceutical

processes

• Develop a comprehensive process flow diagram for a pharmaceutical process

Learning and Teaching Methods:

Lecture, case-study, tutorial




Pre-

Requisite

Modules

code(s)

Co-

Requisite

Modules

code(s)

ECTS

Credits

Module

Code

Module Title

None CPPT9001-9012


Module content:

Lectures

• Types of process.

• Primary and secondary pharmaceutical processing.

•

Routes• Process operations

• Process equipment

• Process descriptions

• Flowsheets (PFD and P&ID)

• Batch record sheets, batch cycles

• Characteristics of chemical processes

• Operating aspects of chemical processes

• Types of chemical process.

• General mass balance equation. Balances on continuous processes and batch processes.

• Mass balance techniques and calculations. Balances on multiple unit processes.

Recycle and bypass streams.

• Balances on processes involving chemical reaction.

• Non-steady state mass balances.

• Application in process development and scale-up.

• Forms of energy. Closed systems and open systems. Energy balance procedures.

• Mechanical energy balances.

• Enthalpy balances. Balances on processes involving chemical reaction.

• Importance in chemical processes.

Laboratory

• There are no laboratory practicals associated with this module

Module Assessment

Assignment 50%

End of module written examination 50%




Pre-

Requisite

Modulescode(s)

Co-

Requisite

Modulescode(s)

ECTS

Credits

Module

Code

Module Title

None CPPT9001-9012


Essential Reading:

Chemical Process Technology, J.A.Moulijn et al, Wiley, 2001 Elementary Principles of Chemical Processes, R.M.Felder and R.W.Rousseau, John Wiley

and Sons, 3rd edition, 2000

Unit Operations in Chemical Engineering, W. McCabe, J. Smith and P. Harriott, McGraw-

Hill,6th edition, 2001

Supplemental Reading:

Pharmaceuticals Vol. 1 – 4, Ed.J.McGuire, 2002, Wiley VCH

Ullmans Encyclopedia of Industrial Chemistry, 6th edition, Wiley – VCH, 2000 Kirk-Othmer Encyclopedia of Chemical Technology, 4th edition, John Wiley, 1998

Thermodynamics of Chemical Processes, G.J.Price, OUP, 1998

Pharmaceutical Production, B. Bennett & G. Cole, IChemE, 2003

Chemical Process Technology, J.A.Moulijn et al, Wiley, 2001 Elementary Principles of Chemical Processes, R.M.Felder and R.W.Rousseau, John Wiley

and Sons, 3rd edition, 2000Unit Operations in Chemical Engineering, W. McCabe, J. Smith and P. Harriott,Chemical Engineering : Volume1 J. M. Coulson, J. F. Richardson et al,

Butterworth-Heinemann,

6th edition, 1999Perrys Chemical Engineers Handbook, R. H. Perry and D. W. Green, 7 th edition, McGraw

Hill, 1997

Engineering Thermodynamics, G. Rogers and Y. Mayhew, 4 th edition, Longman, 1992CRC Handbook of Chemistry and Physics

Concepts of Chemical Engineering for Chemists, Ed. SJR Simons, RSC, 2007Web references, journals and other:

Pharmaceutical Technology Europe

Journal of Organic Process Research and Development

Chemical Engineering Progresshttp://www.rsc.org/lic/knovel_library.htm

http://www.rsc.org/licknovel_library.htm





Pre-

Requisite

Modules

code(s)

Co-

Requisite

Modules

code(s)

ECTS

Credits

Module

Code

Module Title

None CPPT9001-9012


Further Details:

This module is delivered by staff of the School of Chemical and Pharmaceutical Sciences.

24 contact hours

Date of Academic Council approval ………………………….

























Pre-

Requisite

Modules

code(s)

Co-

Requisite

Modules

code(s)

ECTS

Credits

Module

Code

Module Title

None CPPT9001-9012

5 CPPT9002 Heat transfer and fluid flow


Module Description:

This module is concerned with the principles of heat transfer and fluid flow in

pharmaceutical processes. Both these topics are fundamental to the operation of all processsteps such as reaction, distillation, drying, filtration units, centrifugation and crystallisation

as well as to heat transfer and fluid flow equipment such as heat exchangers and pumps.

Module aim

To introduce the students to the basic concepts of heat transfer and fluid flow

To introduce the fundamental principles of heat transfer in chemical and pharmaceutical

processes.

To enable students to make simple design calculations and to specify heat transfer equipment.

To introduce the basic principles and techniques of fluid flow in chemical and pharmaceutical processes and to apply these principles and techniques to industrial

chemical and pharmaceutical processes.

Learning Outcomes:

On completion of this module, the learner will be able to…………….

• Explain the fundamental principles of heat transfer in chemical and pharmaceutical

processes

• Carry out design calculations for heat transfer processes

• Specify heat transfer equipment

• Explain the principles of fluid flow in chemical and pharmaceutical processes















































Pre-Requisite

Modules

code(s)

Co-Requisite

Modulescode(s)

ECTSCredits ModuleCodeModule Title

None CPPT9001-

9012


• Perform design calculations on fluid flow systems

• Specify components for fluid flow systems

• Understand the principles of fluid mixing and apply these concepts to mixing

problems

Learning and Teaching Methods:Lecture, case-studies, tutorial, practical

Module content:

Lectures

• Mechanisms for heat transfer.

• Fourier equation. Steady state conduction. Thermal conductivity.• Conduction through planar and cylindrical surfaces.

• Natural and forced convection.

• Boundary layer concept.

• Heat transfer coefficient, h. Overall heat transfer coefficient, U.

• Expressions for U. Thin walled tube approximation.

• Calculation of h.

• Simple double tube heat exchanger. Co-current and counter current flow.

Temperature profiles.

• LMTD

• Fouling factors, hd.• Q = UAθlmtd

• Energy balance. Q = mc pΔT

• Heat exchange equipment and heat transfer fluids.

• Types of fluids





































































Pre-

RequisiteModules

code(s)

Co-

RequisiteModules

code(s)

ECTS

Credits

Module

Code

Module Title

None CPPT9001-

9012


• Basic equation of fluid flow

• Flow in pipes and channels

• Flow of compressible and incompressible fluids

• Flow of multiphase mixtures

• Flow and pressure measurement

• Mechanical energy balance

• Pumps, blowers, fans

• Principles and application of mixing

Laboratory (2)

• Heat Exchanger

• Fluid flow measurement and pressure drop in a fluid flow system

Module Assessment

Assignment and laboratory 50%


Essential Reading:

Introduction to Heat Transfer , F.P, Incropera et al, 4th edition, John Wiley, 2002Unit Operations in Chemical Engineering, W. McCabe, J. Smith and P. Harriott, McGraw-

Hill, 6th edition, 2001Chemical Engineering : Volume1, J. M. Coulson, J. F. Richardson et al, Butterworth-Heinemann, 6th edition, 1999

Chemical Process Technology, J.A.Moulijn et al, Wiley, 2001

Elementary Principles of Chemical Processes, R.M.Felder and R.W.Rousseau, John Wiley

and Sons, 3rd edition, 2000 Introduction to Heat Transfer , F.P, Incropera et al, 4th edition, John Wiley, 2002








































































Pre-

Requisite

Modules

code(s)

Co-

Requisite

Modules

code(s)

ECTS

Credits

Module

Code

Module Title

None CPPT9001-9012



Heat Transfer (Oxford University Primers), R.H.S.Winterton, Oxford University Press,

1997Two Phase Flow and Heat Transfer, P.B.Whalley, OUP, 1997

Radiation Heat Transfer, H.Jones, OUP, 2000Perrys Chemical Engineers Handbook, R. H. Perry and D. W. Green, 7 th edition, McGrawHill, 1997

Engineering Thermodynamics, G. Rogers and Y. Mayhew, 4 th edition, Longman, 1992

Thermodynamics of Chemical Processes, G.J.Price, OUP, 1998Chemical Engineering : Volume1,J. M. Coulson, J. F. Richardson et al,Butterworth-Heinemann,6th edition, 1999

CRC Handbook of Chemistry and Physics

Web references, journals and other:


Chemical Engineering Progress

http://www.rsc.org/lic/knovel_library.htm

Further Details:

This module is delivered by staff of the School of Chemical and Pharmaceutical Sciences.

24 contact hours


















































Pre-

Requisite

Modules

code(s)

Co-

Requisite

Modules

code(s)

ECTS

Credits

Module

Code

Module Title

None CPPT9001-9012

5 CPPT9003 Mass transfer applications


Module Description:

The principles of mass transfer and its wide applications to different unit operations in the

pharmaceutical industry are introduced and advanced in this module. Distillation is just

one example of a mass transfer process that is widely used in this industry. The underlying principles of distillation are also covered in this module as well as the design of continuous

and batch columns. Absorption of gases is also covered in this module as it is a common

mass transfer application in the pharmaceutical industry.

Module aim

To introduce the basic principles of mass transfer and to apply these principles to chemicaland pharmaceutical production processes

To understand the differences in physical properties of components that are exploited inseparation by distillation.

To understand the process of distillation of a binary mixture.

To be familiar with the different components of distillation equipment.

To understand how to size a continuous column using the McCabe-Thiele graphicalmethod.

To explain the operation of a batch column.

To explain the design and operation of an absorption column.

Learning Outcomes:


• Define the basic principles of mass transfer as applied to chemical and pharmaceutical processes




Pre-

Requisite

Modules

code(s)

Co-

Requisite

Modules

code(s)

ECTS

Credits

Module

Code

Module Title

None CPPT9001-9012


• Explain the underlying principles of separation by distillation

• Develop vapour liquid equilibrium data

• Explain the operation of a distillation column and the importance of reflux and

other operating parameters

• Derive the operating lines for a continuous column

• Apply the McCabe Thiele graphical design method

• Carry out a mass balance on and design a batch distillation column

• Size a distillation system

• Compare constant and variable reflux in a batch column

• Design an absorption process


Lecture, case-studies, tutorial, practical

Module content:

Lectures

• Principles of diffusion and mass transfer between phases

• Mass transfer theories

• Mass transfer operations

• Mixing

• Boiling and condensing different fluids.

• Vapour-liquid equilibrium data and equilibrium curves

• What makes two components different in distillation

• How this difference decides how easy or difficult separation will be.

• Separation of a binary mixture by distillation.




Pre-

Requisite

Modules

code(s)

Co-

Requisite

Modules

code(s)

ECTS

Credits

Module

Code

Module Title

None CPPT9001-9012


• An ideal stage, number of stages, height equivalent to a theoretical plate,

comparison of different types of packing, comparison of packing and plates.

• McCabe-Thiele graphical method to estimate the number of equilibrium stages.

• Column internals - trays, plates and packing

• Reflux rate and quality of separated components. Reflux control.

• Sizing a distillation column

• Energy balance on a column

• Types of reboilers

• Control of temperatures in the still and column head

• Multicomponent distillation (ternary mixtures)

• Batch distillation processes

• Azeotropic distillation

• Extractive distillation

• Packed column design

• Flooding velocity. Generalised Pressure Drop Correlation

• Absorption column design

Module Assessment

Assignment 100%

Essential Reading:

Unit Operations in Chemical Engineering, W. McCabe, J. Smith and P. Harriott, McGraw-Hill, 6th edition, 2001

Chemical Engineering : Volume1, J. M. Coulson, J. F. Richardson et al, Butterworth-

Heinemann, 6th edition, 1999Separation Process Principles, J.D.Seader et al, Wiley, 1998




Pre-

Requisite

Modulescode(s)

Co-

Requisite

Modulescode(s)

ECTS

Credits

Module

Code

Module Title

None CPPT9001-

9012



Encyclopedia of Separation Technology, D. M. Ruthren (ed), Wiley NY, 1997Chemical Engineering : Volume 2

J. M. Coulson, J. F. Richardson et al,


5th edition, 2000Handbook of Separation Process Technology, R.W.Rousseau, Wiley, 1987

Handbook of Separation Techniques for Chemical Engineers, P. A. Schweitzer, McGraw-Hill, 1997

Solvent Recovery Handbook, I. Smallwood, Blackwell, 2002

Handbook of Batch Process Design, P. N. Sharrat (ed), Chapman and Hall/Blackie, 1997 Encyclopedia of Separation Technology, D. M. Ruthren (ed), Wiley NY, 1997

Chemical Engineering : Volume 2,J. M. Coulson, J. F. Richardson et al,

Butterworth-Heinemann,5th edition, 2000

Handbook of Separation Process Technology, R.W.Rousseau, Wiley, 1987

Handbook of Separation Techniques for Chemical Engineers, P. A. Schweitzer, McGraw-Hill, 1997Solvent Recovery Handbook, I. Smallwood, Blackwell, 2002


http://webbook.nist.gov/

Further Details:

This module is delivered by staff of the School of Chemical and Pharmaceutical Sciencesand the School of Control Systems and Electrical Engineering







Pre-

Requisite

Modules

code(s)

Co-

Requisite

Modules

code(s)

ECTS

Credits

Module

Code

Module Title

None CPPT9001-9012



Module Description:

This module examines liquid /liquid extraction processes as used in the chemical and

pharmaceutical industry and also the design and operation of chemical reactors for pharmaceutical production and process modelling.

Module aim

The aim of this topic is to introduce students to the principles of operation of chemical

reactors, the principles of liquid-liquid extraction systems and to perform simple designcalculations for these operations in chemical and pharmaceutical processes.

Learning Outcomes:


• Examine the options and make a judgement on the most feasible reactor system for a given duty.

• Draw up an outline design for a range of chemical reactors and be aware of the

required operating conditions.

• Apply problem solving skills to reactor design

• Explain the principles of operation of liquid-liquid extraction processes• Apply these principles to the operation of industrial liquid-liquid extraction

processes

• Carry out simple design calculations for liquid-liquid extraction processes

• Perform simple modeling operations using modeling software




Pre-

Requisite

Modules

code(s)

Co-

Requisite

Modules

code(s)

ECTS

Credits

Module

Code

Module Title

None CPPT9001-9012



Lectures, tutorials, practicals and case studies

Module content:

Lectures

• Batch isothermal perfectly stirred reactor

•

Batch adiabatic perfectly stirred reactor • Semi-batch perfectly stirred reactor

• Continuous isothermal perfectly stirred reactor

• Continuous adiabatic perfectly stirred reactor

• Continuous isothermal plug flow reactor

• Continuous adiabatic plug flow reactor

• Competitive reactions – parallel and series

• Selectivity

• Choice of reactor/choice of conditions.

• Multi-stage

• Cross-flow

• Non-ideal

• Bio-reactors

• Scale-up

• Partially miscible liquid systems.

• Immiscible liquids

• Choice of solvent for extraction

• Triangular phase diagrams.




Pre-

Requisite

Modules

code(s)

Co-

Requisite

Modules

code(s)

ECTS

Credits

Module

Code

Module Title

None CPPT9001-9012


• Equipment.

• Modes of operation.

• Extractants.

• Examples.

• Design calculations.

• Process modelling

Laboratory (2)

• Reactor operation

• Liquid/liquid extraction

Module Assessment



Essential Reading:

Chemical Reactor Theory: An Introduction, K.G. Denbigh and J.C.R. Turner, 3rd Edition,

Cambridge University Press, 1984Unit Operations in Chemical Engineering, W. McCabe, J. Smith and P. Harriott, McGraw-

Hill, 6th edition, 2001

Separation Process Principles, J.D.Seader et al, Wiley, 1998




Pre-

Requisite

Modulescode(s)

Co-

Requisite

Modulescode(s)

ECTS

Credits

Module

Code

Module Title

None CPPT9001-

9012

5 CPPT9004 Reactor design and separation

processes I


Chemical Engineering : Volume3

Ed. J. F. Richardson and D. G. Peacock,Butterworth-Heinemann,

3rd edition, 1994

Modelling of Chemical Kinetics and Reactor Design,

A.Kayode Coker, Gulf Professional Publishing, 2001Chemical Reaction Engineering, I.S.Metcalfe, OUP, 1997

Handbook of Batch Process Design, P. N. Sharrat (ed), Chapman and Hall/Blackie, 1997Chemical Reaction and Reactor Design, H. Tominaga and M. Tamaki, Wiley, 1997

The Engineering of Chemical Reactions, L. D. Schmidt, OUP, 1998

Chemical Reaction Engineering , O. Levenspiel, Wiley, 1999Chemical Reactor Development from Lab Synthesis to Industrial Production, D. Thoenes,

Kluwer Academic Press, 1994

Handbook of Solvent Extraction, eds. T. C. Lo et al, John Wiley, 1983

Handbook of Solvent Extraction, ed. C.Hanson, 1991Principles & Practice of Solvent Extraction, J. Rydberg, Marcel Dekker, 1992

Chemical Engineering : Volume 2J. M. Coulson, J. F. Richardson et al,Butterworth-Heinemann,

5th edition, 2000

Handbook of Separation Process Technology, R.W.Rousseau, Wiley, 1987Handbook of Separation Techniques for Chemical Engineers, P. A. Schweitzer, McGraw-

Hill, 1997

Solvent Recovery Handbook, I. Smallwood, Blackwell, 2002



Further Details:

This module is delivered by staff of the School of Chemical and Pharmaceutical Sciences.24 contact hours







Pre-

Requisite

Modules

code(s)

Co-Requisite

Modules

code(s)

ECTSCredits

ModuleCode

Module Title

None CPPT9001-9012



Module Description:

This module examines separation processes commonly used in the pharmaceuticalindustry. These are adsorption, crystallisation, filtration and centrifugation.

Module aim

To introduce the basic principles and techniques of adsorption operations and to apply

these principles and techniques to chemical and pharmaceutical production processes.To introduce students to filtration theory and practice as applied in industrial chemical and

pharmaceutical processes.

To understand the principles of crystallisation and centrifugation.

Learning Outcomes:


• List the range of filtration devices available

• Explain the principles behind their design and operation and types of application for which they are most suited.

• Scale-up from laboratory data to estimate filtration area required for a given duty,

suspension and filter cloth.

• Explain the principles of bulk crystallisation

• Describe how crystallisation is carried out in pharmaceutical processes• Apply this knowledge to the operation of industrial crystallisation processes

• Explain the principles and techniques of adsorption as applied in industrial

adsorption processes

• Explain how centrifugation works.




Pre-

Requisite

Modules

code(s)

Co-Requisite

Modules

code(s)

ECTSCredits

ModuleCode

Module Title

None CPPT9001-9012



Lectures, tutorials, laboratories and case study

Module content:

Lectures

• Adsorption equilibrium

• Adsorption from liquids

• Adsorption equipment

• Design calculations

• The filtration process and the key objectives

• Factors that affect filtration performance

• Types of industrial filtration equipment and their descriptions

• Principles behind their design

• Operational characteristics• The filtration equations

• The filtration constants and their application to scale-up

• Sizing a press filter and a rotary vacuum filter

• Sterile filtration

• Growth and properties of crystals

• Equilibrium and yield

• Particle size control

• Equipment

• Polymorphism

• Centrifugation

Laboratory

• Filtration

• Crystallisation




Pre-

Requisite

Modules

code(s)

Co-Requisite

Modules

code(s)

ECTSCredits

ModuleCode

Module Title

None CPPT9001-9012


Module Assessment



Essential Reading:

Unit Operations in Chemical Engineering, W. McCabe, J. Smith and P. Harriott, McGraw-

Hill, 6th edition, 2001


Chemical Engineering : Volume 2,J. M. Coulson, J. F. Richardson et al,Butterworth-Heinemann,

5th edition, 2000

Perry's Chemical Engineers' Handbook , R.H. Perry, D.W. Green, McGraw Hill, 7th edition,

1998 From Molecules to Crystallisers, R.J.Davey et al, OUP, 2001

Separation and Purification by Crystallisation, G. D. Botsaris and K. Toyokura, ACS,1997

Crystal Growth of Organic Materials, A. Myerson et al, ACS, 1996

Crystallisation, J. Mullin, Butterworth – Heinemann, 1997 Physical Characterisation of Pharmaceutical Solids, H. G. Brittain, Marcel Dekker, 1995Chemical Engineering: Particle Technology and Separation Processes Volume 2, J.M.

Coulson, J.F. Richardson, J.R. Backhurst, J.H. Harker, Butterworth-Heinemann, 5th

edition, 2000Chemical Engineering : Volume1,J. M. Coulson, J. F. Richardson et al,

Butterworth-Heinemann, 6th edition, 1999 Powders and Solids, Ed. W. Hoyle, RSC, 2001 Handbook of Conveying and Handling of Particulate Solids (Handbook of Powder

Technology),

A. Levy (Editor), H. Kalman (Editor) 2001Separation and Purification by Crystallisation, G. D. Botsaris and K. Toyokura, ACS,

1997




Pre-

Requisite

Modules

code(s)

Co-

Requisite

Modules

code(s)

ECTS

Credits

Module

Code

Module Title

None CPPT9001-9012


Crystal Growth of Organic Materials, A. Myerson et al, ACS, 1996

Crystallisation, J. Mullin, Butterworth – Heinemann, 1997

Separations Technology: Pharmaceutical and Biotechnology Applications, W. P. Olson,CRC, 1995

Powder Technology and Pharmaceutical Processes, ed. D. Chulia et al, Elsevier, 1993


http://www.nzifst.org.nz/unitoperations/index.htm

Further Details:

This module is delivered by staff of the School of Chemical and Pharmaceutical Sciences

and the School of Control Systems and Electrical Engineering

24 contact hours







Pre-

Requisite

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code(s)

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Requisite

Modules

code(s)

ECTS

Credits

Module

Code

Module Title

None CPPT9001-9012



Module Description:

This module is concerned with drying of bulk API, particulate solids technology, transport

of dry powder/particles, associated material handling issues and membrane processes.

Module aim

To introduce the basic principles and techniques of materials handling in chemical and

pharmaceutical processes.To introduce the basic principles and techniques for the drying of materials in industrial


To understand the characteristics of particulate solids, how they can be conveyed andstored, how they are blended and classified and how particle size reduction and

enlargement is achieved.

To introduce the principles of membrane separation and the membrane processes used in

the manufacture of pharmaceuticals

Learning Outcomes:


• Explain the theoretical principles of the drying process

• List the different types of drying equipment

• Specify drying equipment

• Explain the properties of particulate solids

• Describe how particulate solids can be transported• Explain the principles and practice of particle size reduction and classification

• Appreciate the factors to be considered in the handling of materials in chemical and pharmaceutical processes

• Explain the techniques to be used in the handling of materials in chemical and

pharmaceutical processes




Pre-

Requisite

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code(s)

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Requisite

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code(s)

ECTS

Credits

Module

Code

Module Title

None CPPT9001-9012


• Understand the scientific and technology principles of membrane separation processes used in the manufacture of pharmaceuticals


Lecture, tutorial, laboratory and case study

Module content:

Lectures

• Storage of materials, material handling and transfer

• Hazards

• Risk assessment

• Legislation

•

Occupational hygiene issues• Containment of hazardous substances

• General principle of drying. Psychrometric charts.

• Classification of dryers

• Heat transfer in dryers

• The mechanism of moisture movement during drying

• Freeze-drying.Spray drying. Fluidised bed drying.

• Drying equipment and design considerations

• Dryers for solids and pastes

• Dryers for solutions and slurries

• Particle size distribution and measurement

• Properties of solids

• Transport and conveying of particulate solids

• Measurement and control of solids flowrate

• Blending of solid particles

• Size reduction - mechanical and fluidised milling




Pre-

Requisite

Modulescode(s)

Co-

Requisite

Modulescode(s)

ECTS

Credits

Module

Code

Module Title

None CPPT9001-

9012


• Classification of solid particles - gravity settling, centrifugation, electrostatic

separation, flotation

• Principles of size enlargement and granulation

• Material handling

• Membrane types and materials

• Reverse osmosis

• Pervaporation• Ultrafiltration

• Nanofiltration

• Equipment, processes and applications

Laboratory

• Drying/ Spray drying

• Membrane separation

Module Assessment


Essential Reading:

Unit Operations in Chemical Engineering,

W. McCabe, J. Smith and P. Harriott,

McGraw-Hill,6th edition, 2001


Chemical Engineering : Volume 2

J. M. Coulson, J. F. Richardson et al,


5th edition, 2000




Pre-

Requisite

Modulescode(s)

Co-

Requisite

Modulescode(s)

ECTS

Credits

Module

Code

Module Title

None CPPT9001-

9012


Perry's Chemical Engineers' Handbook , R.H. Perry, D.W. Green, McGraw Hill, 7th edition,

1998Chemical Engineering: Particle Technology and Separation Processes Volume 2, J.M.

Coulson, J.F. Richardson, J.R. Backhurst, J.H. Harker, Butterworth-Heinemann, 5th

edition, 2000

Powders and Solids, Ed. W. Hoyle, RSC, 2001 Handbook of Conveying and Handling of Particulate Solids (Handbook of Powder

Technology),A. Levy (Editor), H. Kalman (Editor) 2001

Separations Technology: Pharmaceutical and Biotechnology Applications, W. P. Olson,

CRC, 1995

Powder Technology and Pharmaceutical Processes, ed. D. Chulia et al, Elsevier, 1993Safe Handling of Chemicals, Vol.1 – 3, P.A.Carson and C.J.Mumford, Longman, 1996

Materials Handling Handbook , D.E.Mulcahy, McGraw Hill, 1999

Membrane Processes: A Technology Guide, P. T. Cardew and M. S. Le, RSC, 1998 Membrane Technology in the Chemical Industry, S.P.Nunes and K.V.Peinemann (Eds.),

Wiley-VCH, 2001



Further Details:

This module is delivered with cooperation by staff of the School of Chemical andPharmaceutical Sciences and the School of Control Systems and Electrical Engineering.

24 contact hours







Pre-

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Modules

code(s)

Co-

Requisite

Modules

code(s)

ECTS

Credits

Module

Code

Module Title

None CPPT9001-9012


Module author: Gavin Duffy

Module Description: This module is offered to students who have not previously studied

this subject area. It is therefore introductory in nature and aims to provide the

student with an understanding of basic control theory and practice and how control is

implemented in industry. Automation and process control using programmable logic

controllers (PLCs) in conjunction with supervisory control and data acquisition(SCADA) software is explained and practiced.

Module aim To provide the student with sufficient knowledge to understand how

processes are controlled in a modern automated facility in the chemical and pharmaceutical industries.

Learning Outcomes:On completion of this module, the learner will be able to…………….

• Explain the operation of a PLC, how inputs and outputs are connected to it, how a program is executed inside it and how information can be taken from it.

• Edit a PLC program operating on several inputs and outputs; download the programto the PLC and test its operation.

• List a number of analogue instruments and explain how they are connected to a

PLC.

• Develop a block diagram for an instrumentation system and re-range a raw value

into engineering units.

• Differentiate between open loop and closed loop control.

• Develop a block diagram for closed loop control and explain the function of each

block.

• Explain proportional, integral and derivative control and how these can becombined and tuned to produce effective controllers.




Pre-

Requisite

Modulescode(s)

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Requisite

Modulescode(s)

ECTS

Credits

Module

Code

Module Title

None CPPT9001-9012


• Develop a mathematical model for a process and use this to define the transfer

function of the control system.

• Carry out an open loop step response of a process.

• Explain how control algorithms such as on/off, proportional, integral and derivativeare implemented in the PLC.

• List the primary features of a SCADA software package and explain how they areof use to automation users.

• Edit and test a SCADA screen to read/write digital and analog signals from/to a

PLC.

• Commission an automated control system.

• List the controlled devices used in industry and briefly explain how these work.

•

Work in a group to design and build a simple control system using automationequipment such as the temperature control of a water tank using a PLC and

SCADA interface.

• Write a control philosophy document for a discrete and/or continuous process thatis automated using a PLC.

• Prepare and deliver a report and/or presentation on an automation and control topic.


A predominantly project based learning approach is taken with students working in

groups on a number of projects over the course of this module. Since this module

involves the use of proprietary software some formal instruction is initially needed but lectures and laboratories are based around the projects.

Module content:

Lectures/Tutorials




Pre-

Requisite

Modules

code(s)

Co-

Requisite

Modules

code(s)

ECTS

Credits

Module

Code

Module Title

None CPPT9001-9012


• PLC Programming

• SCADA software development

• Control philosophy documents

• Negative feedback closed loop control system

• Process and control system modelling

Projects

One large project to test and commission a control system is completed during the module.Initially, PLC operation and basic programming is investigated. This is then followed by

the addition of analog signals to the PLC and their representation at SCADA level. Finally

a complete negative feedback control system is developed with setpoint entry andinformation display at SCADA level and control of a real process implemented in the PLC.

Module Assessment

The module has both a laboratory and examination assessment. The laboratory is assessed

by report, interview and presentation. An examination is presented at the end of the

module.

Essential Reading:Control Engineering, Bolton, W.


Introduction to Control System Technology, Bateson, R. N.




Pre-

Requisite

Modules

code(s)

Co-

RequisiteModules

code(s)

ECTS

Credits

Module

Code

Module Title

None CPPT9001-

9012



http://www.controleng.com

http://student.dit.ie/eng/staff/

Further Details:

24 contact hours



http://www.controleng.com/

http://www.controleng.com/



Pre-requisite

modules codes

Co-requisite

modules codes

ECTS Credits Module code Module title

none CPPT9001-

9012

5 CPPT9008 Process utilities,

process supportservices,

materialhandling and process safety

Module author: Paul Ashall

Module Description:

This module is concerned with process utilities and process support services, materials

handling and process safety.

Module aims:To introduce the basic principles and techniques of materials handling in chemical and

pharmaceutical processes.To introduce the principles of operation of plant services and utilities in the operation of


To introduce the principles of process safety in the design, development and operation of

chemical processes.

Learning Outcomes: On completion of this topic students should be able to• understand and appreciate the factors to be considered in the handling of materials

in chemical and pharmaceutical processes

• know the techniques to be used in the handling of materials in chemical and


• know and understand how plant services and utilities operate in chemical and


• understand the principles of safety in the design, development and operation of chemical processes

• apply these principles in practice

• perform an hazard and operability study


Lecture, tutorial, case-study




Pre-requisite

modules codes

Co-requisite

modules codes


none CPPT9001-

9012


process supportservices,material

handling and

process safety

Module content:

HazardsRisk assessment

Legislation

Occupational hygiene issues

Containment of hazardous substancesClean room technology

Hazardous processesPlant design and process design

Environmental impact

Pollution control

Storage of fluids and solidsTransportation and metering of fluids

Transportation of solids

Information sourcesCooling water systems

Steam distribution systemsOther heat transfer fluid systems Nitrogen and inert gas systems

Vacuum systems

HVAC

Water treatment systemsAir

Health and safety legislation.

Chemical safety.Hazard identification: HAZOPS etc

Thermal hazards

Safety equipmentHazardous area classification

Storage

Module Assessment:

Assignment (100%)




Pre-requisite

modules codes

Co-requisite

modules codes


none CPPT9001-

9012



handling and

process safety

Essential Reading:

Unit Operations in Chemical Engineering,

W. McCabe, J. Smith and P. Harriott,

McGraw-Hill,

6th edition, 2001Chemical Engineering : Volume3

Ed. J. F. Richardson and D. G. Peacock,Butterworth-Heinemann,

3rd edition, 1994

Chemical Engineering : Chemical Engineering Design Volume 6 , R. K. Sinnott, 3rd edition,

Butterworth-Heinemann, 1999 Hazard Identification Methods, F. Crawley & B. Tyler, IChemE, 2003

HAZOP: A Guide to Best Practice, B. Tyler et al, 2000


Safe Handling of Chemicals, Vol.1 – 3, P.A.Carson and C.J.Mumford, Longman, 1996 Materials Handling Handbook , D.E.Mulcahy, McGraw Hill, 1999 Hazardous Chemicals Handbook , P.A.Carson and C.J.Mumford, Butterworths, 2002

Perry's Chemical Engineers' Handbook , R. H. Perry, D.W. Green, 7th edition, McGraw

Hill, 1998Chemical Reaction Hazards, J. Barton and R. Rogers, I Chem E, 2nd edition, 1997 Process Safety Analysis – An Introduction, R. Skelton, I Chem E, 1997

Safe Handling of Chemicals in Industry, R. A. Carson and C. J. Mumford, Longman, 1988

Brethericks Handbook of Reactive Chemical Hazards, P. G. Urban, ButterworthHeinemann, 1995

Safety Assessment for Chemical Processes, J. Steinbach, Wiley – VCH Weinheim, 1998

Safety in the Process Industries, R. King, Butterworth, 2

nd

edition, 1998 Hazop and Hazan: Identifying and Assessing Process Industry Hazards, T.A.Kletz,

Hemisphere Pub. , 4th edition, 1999

ISPE vol. 4: Water and Steam Systems, 2001Containment Systems: A Design Guide, N. Hirst et al, IChemE, 2002




Pre-requisite

modules codes

Co-requisite

modules codes


none CPPT9001-

9012



handling and

process safety


www.hsa.ie

Further Details: contact hours - 24


http://www.hsa.ie/

http://www.hsa.ie/




Pre-requisite

modules codes

Co-requisite

modules codes


none CPPT9001-

9012

5 CPPT9009 Process design

anddevelopment

Module author: Paul Ashall/Claire McDonnell

Module Description: This module covers the design and development of pharmaceutical

processes.

Module aims:

To introduce the fundamental principles of chemical development and process

development in the pharmaceutical industry.

To enable students to plan a process development programme and to participate in a

chemical and process development team.Learning Outcomes:

On completion of this topic students should be able to

• understand the principles of chemical development and process development in the

pharmaceutical industry

• plan a process development programme

• participate in a chemical and process development programme

• design a pharmaceutical process


Lecture, tutorials, case-study

Module content:

Chemical development.Choice of chemistry and route. Green chemistry.

Equipment. Reactors. Separation processes. Utilities and process support services.

Process economics.Scale-up.

Safety and environmental issues.

Flowsheets generalP and I flowsheets

Flowsheet simulation

Process optimisation.

Product quality.Material handling.

Process control.

Regulatory issues.PAT

Case studies.

Module Assessment:Assignment (100%)




Pre-requisite

modules codes

Co-requisite

modules codes


none CPPT9001-9012

5 CPPT9009 Process designanddevelopment

Essential Reading:

Practical Process Research and Development , N.G.Anderson, Academic Press, 2000

Chemical Engineering : Chemical Engineering Design Volume 6 , R. K. Sinnott, 3rd edition,

Butterworth-Heinemann, 1999EC Guide to GMP – Revision to Annex 1 (Eudralex Guide)


Journal Organic Process Research and Development , 1997 –

Process Development , S. Lee and G. Robinson, OUP, 1995 Process Plant Design, J. R. Backhurst and J. H. Harker, Heinemann, 1981

Process Development, J.Atherton, OUP, 1999Top Drugs: Top Synthetic Routes, J.Saunders, OUP, 2000

ISPE Baseline Pharmaceutical Engineering Guides Vol. 1 Bulk Pharmaceutical Chemicals

Baseline Guide, 1996

Pilot Plants and Scale Up of Chemical Processes, W. Hoyle, RSC, 1997 Principle of Process Research and Chemical Development in the Pharmaceutical Industry,

O. Repic, Wiley Interscience, 1998

Pharmaceutical Production Facilities – Design and Applications, G. M. Cole, Taylor andFrancis, 2nd edition, 1998

Scale Up Methodology for Chemical Processes, J. P. Euzen et al, Technip Paris 1993 Handbook of Chemical Process and Design, J. Speight, McGraw-Hill, 2001The Pilot Plant Real Book, F. X. McConville, FXM Eng & Des, 2002

Pharmaceutical Engineering Vol. 1 – 12, Edwards, Butterworth Heinemann, 2005

Encyclopedia of Pharmaceutical Technology, J. Swarbrick, Marcel Dekker, 2002

Product and Process Design Principles, W. D. Seider et al, 2nd edition, Wiley, 2003




Journal of Organic Research and Development

Further Details: Contact hours - 24.







Pre-requisite

modules codes

Co-requisite

modules codes


none CPPT9001-

9012

5 CPPT9010 Facility design

and operation.

Module author: Paul Ashall/Trevor McSharry

Module Description: This module covers the key elements of basic preliminary design

and operation of pharmaceutical manufacturing processes and facilities.

Module aims:

To enable students to understand and apply the key elements of pharmaceutical process and

facility design and operation. e a secondary pharmaceutical production facility

Learning Outcomes:On completion of this topic students should be able to

• Understand the key elements associated with the design/ operation of pharma processes/ facilities

• Complete a preliminary design for a pharmaceutical manufacturing process and its

facility.design and operate a secondary pharmaceutical facility


Lecture, tutorial, case-study

Module content:

Safety and environmental issues including containment and .material handling.Regulatory issues with reference to IMB, FDA and EMEA.

Various Design and Operational guides such as GEP, GMP etc.

Process optimisation.Product quality.

Material handling.

Process control.

Regulatory issues.GEP

Design of pharmaceutical finish facilities. Solid dosage forms.

Blending, granulation, milling etcLiquids.

Aseptic processing.

Clean room technologyProcess support services

Formulation science & technology

Module Assessment:



Assignment (100%)


Pre-requisitemodules codes

Co-requisitemodules codes


none CPPT9001-

9012

5 CPPT9010 Facility design

and operation.

Essential Reading:

ISPE Baseline Guide vol. 3 Sterile Manufacturing Facilities, 1999

ISPE Vol. 2 Oral Solid Dosage Forms, 1998

Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – CurrentGood Manufacturing Practice (FDA)

ASME BPE 2002EUDRALEX Volume 4 - Medicinal Products for Human and Veterinary Use : Good

Manufacturing Practice

EC Guide to GMP – Revision to Annex 1 (Eudralex Guide)

Introduction to Contamination Control and Cleanroom Technology, M. Ramstorp, Wiley-VCH, 2000

Containment Systems: A Design Guide, N. Hirst et al, IChemE, 2002

Supplemental Reading: Pharmaceutical Production Facilities – Design and Applications, G. M. Cole, Taylor and

Francis, 2

nd

edition, 1998Pharmaceutical Engineering Vol. 1 – 12, Edwards, Butterworth Heinemann, 2005Encyclopedia of Pharmaceutical Technology, J. Swarbrick, Marcel Dekker, 2002

Health and Safety at Work Regulations 2006.

FDA (especially CFR part 11 guidelines,)



http://www.fda.govPharmaceutical Tecechnology Europe




http://www.fda.gov/


http://www.fda.gov/




Pre-requisite

modules codes

Co-requisite

modules codes


none CPPT9001-

9012

5 CPPT9011 Management

aspects of pharmaceutical production

Module author: Paul Ashall/Hassan Ali

Module Description:

This module is concerned with management aspects of the pharmaceutical industry.

Module aims:

To understand the nature of projects and the various approaches to their management.

To introduce the basic principles and techniques of economics in chemical and pharmaceutical processes and to apply these principles and

techniques in the development and operation of chemical and pharmaceutical processes.

To introduce the principles of environmental management in the pharmachem industry

To provide a knowledge and understanding of environmental management systems.To develop the skills necessary to develop, implement and operate an effective

environmental management system.

To provide knowledge and understanding of the tools, techniques and practices required for effective management of the environment.

To give the student a working knowledge and understanding of key environmentallegislation.

Learning Outcomes:


• understand the principles of project management

• know how project management techniques are used in chemical and


•apply project management techniques

• understand the principles of economics as applied to chemical and pharmaceutical

processes

• calculate production costs, selling cost and profit

• understand and apply the principles of environmental management




Pre-requisite

modules codes

Co-requisite

modules codes


none CPPT9001-9012

5 CPPT9011 Managementaspects of

pharmaceutical

production

• understand the principles of environmental management systems

• devise, implement and operate an effective environmental management system

• understand the principles and practice of waste management in the chemical and pharmaceutical industry

• implement effective waste management practices in the chemical and pharmaceutical industry

• apply the various tools, techniques and practices for effective environmentalmanagement in the operation of chemical and pharmaceutical processes

• access and have a working knowledge of the key environmental legislation which is

important in the operation of chemical and pharmaceutical processes


Lecture, tutorial, case-study.

Module content:

Characteristics of a project

Project life cycle

Principles of project managementProject management functions

Role of project manager

Scope managementLessons from ‘real life’

Structure and organisation

Costs and cost factorsPrices and competition

Evaluation of capital investment, payback period, average rate of return, discount cash flow

and internal rate of returnEnvironmental management systems. Environmental management principles.

ISO 14001.

EMAS.Waste treatment and disposal. Effluent treatment. Emissions to atmosphere.




Pre-requisite

modules codes

Co-requisite

modules codes


none CPPT9001-9012

5 CPPT9011 Managementaspects of

pharmaceutical

production

Waste minimisation.IPPC.

BATNEEC/BAT.

Environmental indicators. Standards. Environmental information. Monitoring. Modelling.Environmental auditing principles. Eco-audit. EMS.

Environmental communication and reporting.Environmental risk management, risk analysis and risk assessment.

Life cycle assessment.

Clean technology/clean production.

Resource management. Energy management.Materials management, mass balance and material flow in processes.

Key environmental legislation such as: Air Pollution legislation

Water pollution legislation Noise pollution legislation

Environmental Impact Assessment, Council Directive 85/337.Council Directive 97/11/EC.EC (EIA) Regulations, 1989 and1994.

Waste Management legislation

Environmental Protection Agency Act, 1992.

Eco-Management and Audit Scheme Regulation, EEC 1836/93(EMAS).99/31/EC Council Directive on Landfill of Waste.

EC (Major Accident Hazards at Certain Industrial Activities) Regulations, 1986.

(Council Directive 96/82/EEC, Council Directive 82/501/EEC.)SI No.133 of 1993:Access of Information on the Environment Regulations, 1993.

Module Assessment:

Assignment (100%)

Essential Reading:

A Guide to the Project Management Body of Knowledge, Project Management Institute,

2000




Pre-requisite

modules codes

Co-requisite

modules codes


none CPPT9001-9012

5 CPPT9011 Managementaspects of pharmaceutical

production

Engineering Economics and Cost Analysis,C.A.Collier, Harlow: Addison-Wesley,

3rd Edition, 1998

Environmental Management , C. J. Barrow, Routledge, 1999

Installing Environmental Management Systems, C. Sheldon and M. Yoxon, Earthscan,

2001

Pollution Causes, Effects and Control , Ed. R. M. Harrison, 4th

edition, RSC, 2001 Environmental Management Principles and Practice, C. J. Barrow, Routledge, 1999

Environmental Management Tools for SME’s, Ed. R. Starkey, EEA, 1998 Environmental Policy, Legislation and Practices, K.T.Cullen, 2000


Project Management-A Systems Approach to Planning, Scheduling and Controlling ,

H.Kerzner, 7th editionThe Handbook of Project Management, T.L.Young

Principle of Engineering Analysis,

J.A.White, M.H.Agee and K.E.CaseJohn Wiley and Sons

3

rd

edition, 1989 Principles of Engineering Economy,E.L.Grant, W.G.Ireson and R.S.Leavenworth,

John Wiley and sons

8th edition, 1990 Environmental Management in Practice, Vol.1, Ed. B. Nath et al, Routledge, 1998 Handbook of Environmental Management and Technology, G. Holmes, B. R. Singh, L.

Theodore, John Wiley, 1993

ISO 14001ISO 14004

Pollution Prevention for Chemical Processes, D. T. Allen, John Wiley and Sons, 1997

Air Quality Management , Eds. R. E. Hester and R. M. Harrison, RSC, 2000Waste Incineration and the Environment , Eds. R. E. Hester and R. M. Harrison, RSC, 2000

Croners Waste Management , Croner Publications, London, 1991

Control of VOC Emissions: Conventional and Emerging Technologies, P. Hunter, S. T.Oyama, Wiley NY, 2000

Management of Process Industry Waste, Ed. D. Bahu, B. Crittenden, J. O’Hara, Inst. of

Chem. Eng., 1997




Pre-requisite

modules codes

Co-requisite

modules codes


none CPPT9001-9012

5 CPPT9011 Managementaspects of pharmaceutical

production

Waste Minimisation: A Chemists Approach, Ed. Martin and Bastock, RSC, 1994Chemistry of Waste Minimisation, J. H. Clark (ed) Blackie/Chapman and Hall, 1995

Environmental Management in Practice, Eds. B. Nath, L. Hens, P. Compton, D. Devuyst,

Routledge, 1998 Vol.1

Risk Assessment and Risk Management , Eds. R. E. Hester and R. M. Harrison, RSC, 2000Case Studies in Environmental Technology, P. N. Sharratt and M. Sparshott, I Chem E,

1998The ISO 14000 EMS Audit Handbook, G. P. Johnson, St. Lucie Press, 1997



www.boc.ie

www.epa.ie




http://www.boc.ie/

http://www.epa.ie/


http://www.boc.ie/

http://www.epa.ie/




Pre-requisite

modules codes

Co-requisite

modules codes


none CPPT9001-9011

5 CPPT9012 Regulatoryaspects, GMPand process

validation.

Module author: Paul Ashall, Anne Greene

Module Description:

This module is concerned with the regulatory aspects of the pharmaceutical industry.

Module aims:

To give a knowledge and understanding of the principles and practice of GMP in the pharmaceutical industry.

To give a knowledge and understanding of quality assurance specifically related to the pharmaceutical industry.

To give a knowledge and understanding of the principles and practice of validation in the

pharmaceutical industry.

To provide knowledge and understanding of the Regulatory Framework for themanufacture and sale of pharmaceuticals in Ireland the EU and the US.

Learning Outcomes:On completion of this module, the learner will be able to…………….

•Recognise all aspects of Good Manufacturing Practices (GMP) and make an easy

transition to working in a GMP environment,

• understand quality assurance as it applies to the pharmaceutical industry

•Understand the principles and practice of validation in the pharmaceutical industry

•Design and execute selective validation studies

•Describe the regulatory framework for the manufacture and sale of pharmaceuticalsin the EU and US

•Understand the documents required to ensure a pharmaceutical company complies

with the regulatory requirements.

Learning and Teaching Methods:Lecture, tutorial, case-study.

Module content:

Quality management systems.Good Manufacturing Practices

Auditing and inspection

Validation overview




Pre-requisite

modules codes

Co-requisite

modules codes


none CPPT9001-

9011

5 CPPT9012 Regulatory

aspects GMPand processvalidation.

Validation Master Plan

Commissioning and Equipment Qualification

Process ValidationComputer systems validation

Cleaning validation

Documentation

Pharmaceutical legislation that regulates the pharmaceutical industry in Ireland, EU andUS.

The documents that are required to support this regulation and maintain a company in acompliant state

Module Assessment:

Assignment (100%)

Essential Reading:

The Rules Governing Medicinal Products in the European Union. Volume 4, Guide toGood manufacturing practice in the Pharmaceutical industry,

US Code of Federal Regulations –CFR title 21,Food and Drugs Pharmaceutical Process Validation, Eds. I.Berry and R.Nash, Marcel Dekker, 1993 European Commmission Directive 91/365/EEC

The Rules Governing Medicinal Products in the European Union.

US Code of Federal Regulations –CFR title 21,Food and Drugs

Supplemental Reading: Good Manufacturing Practice – A Guide to Practical Quality Management, P. Uys,

Knowledge Resources, 1994

ISPE Baseline Pharmaceutical Engineering Guides Vol. 1, 1996Validation of Bulk Pharmaceutical Chemicals, I. R. Berry and D. Harpaz, Interpharm, 1997

Biopharmaceutical Process Validation, Eds. G. Sofer et al, Marcel Dekker Inc. 2000

Web references, journals and other:Journal of Validation Technology






Pre-requisite

modules codes

Co-requisite

modules codes


none CPPT9001 -

9012

30 CPPT9013 Project

Module author: Paul Ashall.

Module Description:

Research project

Module aims:

The aim of this module is ……………..

To enhance the quality of individual student’s thinking, concept development,

communication and management abilities.

Provide experience of initiating, planning, producing and presenting project work.

To provide experience in professional practice, time-management, team interactionand communication skills.

To promote innovation.

Learning Outcomes:


Apply the skills acquired within a project framework, to the required level and

within a set time limit.

Demonstrate the ability to initiate, plan, develop and carry out a project.

Use initiative, make decisions, anticipate outcomes, plan ahead and actively

manage responses.

Apply leadership and support skills as required.

Conduct individual, independent research.

Apply high level skills in a competent and professional manner.

Communicate ideas and developments with clarity.


Project based learningSelf directed study

Workshops

Module content:

This module is intended as the applied culmination of knowledge and skills acquired

during the course. Students will undertake a major project requiring the amalgamation of

all previous learning. The project work is generally work-based.The project allows the student the opportunity to undertake a detailed study of a topic

relevant to pharmaceutical and chemical process technology. The standard expected for

the final body of work should be appropriate for Masters degree level.




Pre-requisite

modules codes

Co-requisite

modules codes


none CPPT9001 -9012

30 CPPT9013 Project

Module Assessment:

Dissertation, oral presentation, project plan

Essential Reading:

Sharp, A.J. and Howard, K., (2000) The management of a student research project , 2nd

Edition, Great Britain, Gower.

Kumar, R., (1999) Research Methodology – a step by step guide for beginners, London

Sage


Martella, R.C., Nelson, R., Marchand - Martella, N., (1999) Research Methods - learning

to become a critical research consumer , USA, Allyn and Bacon.

Blaxter, L., Hughes, C. and Tight, M., (2001) How to Research, 2nd Edition, Buckingham,Open University Press.

Becker, H.S., (1998) Tricks of the trade: How to think about your research while you’re

doing it , University of Chicago.Anderson, J. and Poole, M., (2001), Assignment and Thesis Writing , 3rd Edition, Australia,

Wiley & Sons.Lester, J.D. (1996) Writing research papers: A complete guide, 8th Edition, London,HarperCollins.

Preece, R., (1994), Starting research: An introduction to academic research and

dissertation writing , London: Pinter Publications

Marshall, P., (1997) Research methods: How to design and conduct a successful project ,Plymouth: How to Books.


Further Details:




In-Course Assessment

Students are expected to complete and submit, in typed form, designated assignments and

practical reports from completed modules.

These assignments are comprised of essays, literature reviews, case studies, design

exercises, practical reports, problem sheets and group/team assignments.

Students research each assignment and develop an agreed work plan with the relevant

member(s) of the Programme Team before commencing the assignment. Deadlines for

submission of all assessment and assignment work are set by course tutors and strictly

adhered to. In-course work completed in a given semester is normally submitted before the

end of that semester. Students are expected to maintain a file of work set, completed and

assessed. This file is required for inspection by the External Examiners and must be made

available by the student when required. Members of the Programme Team may enforce a

penalty system for late submission of work. One quarter of marks awarded for any

assessment or assignment may be lost for late submission up to 1 week late. Half of marks

awarded may be lost for late submission from 1 to 2 weeks late. After 2 weeks late all

marks may be lost for that assessment or assignment.

Normally assignments are assessed by the relevant member(s) of the Programme Team.

The mark obtained is communicated to the student with comments and guidance, as

appropriate.

Where difficulties arise in relation to submission of assignments the Programme Director is

consulted and acts to resolve the matter.

In-course assessment includes laboratory based practicals for some modules. Students are

expected to complete and submit laboratory reports for each of these modules. Guidance

will be given as to the structure and organisation of laboratory reports.

Reports are submitted in typed form before the end of each semester. Where difficulties

arise in relation to completion or submission of laboratory reports the Programme Director

is consulted and acts to resolve the matter. Where difficulties are not resolved, the

Programme Director has recourse to the Head of School.



Assignments

Each student is required to submit in-course assignments. The assignment mark, written

examination (if applicable) and the practical mark (if applicable) give a total of 50

available marks per module. The pass mark for each module is 40%.

Laboratory Practicals

Each student is required to carry out required practical work and submit laboratory reports

from designated modules. The marking scheme considers presentation of report,

understanding and written communication, aims/objectives and background, experimental

work and results, discussion and conclusions, and references.

Written examinations

Some modules are in part assessed by an end of semester written examination (see module

descriptors). Details of examination structures and organisation will be given to students.



Project Assessment

The project is assessed under three main headings:

(i) Practical Performance (50 marks)

(ii) Oral Presentation (50 marks)

(iii) Thesis/dissertation (250 marks)

(iv) Project plan (50 marks)

(a) Practical performance is, in the main, assessed by the industrial supervisor in

consultation with the internal supervisor, except where the project is performedinternally.

(b) Oral presentation of project work is assessed by at least two members of the

Programme Team, students and staff of the Faculty are encouraged to attend. The

presentation will normally be of 20 minutes duration followed by 10 minutes for

questions.

A draft of the report is assessed/corrected by the internal supervisor and returned to the

student for amendment and production of the final thesis. The thesis, in typed, bound form,

is assessed by two internal examiners (one of which is the internal supervisor). All final

theses are monitored by the External Examiners to ensure that they meet the required

standards for the Award and are of a broadly equivalent level between candidates and topic

areas.

The pass mark is 40%.

Overall Assessment Scheme

Breakdown of Marks

Module Number Total

Marks

Taught 12 600

Project/dissertation 1 300

900



Course journal list

Chemical Engineer

Chemical Engineering Progress

Chemical and Engineering News

Organic Process Research and Development


Course book lists

(see module descriptors)



Course management

Queries regarding the management of the programme should be directed to the chairperson

of the Programme Committee.

Queries of an academic nature on specific modules or subjects should be directed to the

appropriate tutor or lecturer.

Queries regarding the administration of the programme should be directed to the School

secretary.

Contact details

All course lecturers are eager to help you in your academic and professional development

and can be contacted by phone or e-mail. There is also WebCT/student website support for

this programme.

Attendance

A minimum attendance level of 80% is required at lectures, tutorials etc for each module.

Attendance at practicals is mandatory. Attendance at all programme components is

monitored.

Quality Assurance

DIT QA procedures will be adopted.



Guidance to student

Study skills

Students are required to have or to develop the necessary study skills for self-directed

learning.

Report writing

Guidance will be given on report writing for assignments, practical reports and dissertation.

Laboratory safety

Laboratory safety rules must be complied with.

Teaching locations

Teaching will take place in DIT, Kevin St.

Research skills

Students must develop the necessary research skills for project work and will be directed

and assisted in this regard.

Resources

DIT libraries and library service

School of Chemical and Pharmaceutical Sciences computer room (346)

School of Chemical and Pharmaceutical Sciences Chemical Technology Laboratory

School of Chemical and Pharmaceutical Sciences Analytical Chemistry Laboratory

School of Control Systems and Electrical Engineering Control Systems Laboratory

Faculty of Science lecture and tutorial rooms.

Documents

DT275 Student Handbook