Student Handbook - Dublin Institute of Technologyeleceng.dit.ie/gavin/DT275/DT275 Student...

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 to

operate 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 Title1 CPPT9001 Pharmaceutical processes – basic principles

2 CPPT9002 Heat transfer and fluids3 CPPT9003 Mass transfer applications in pharmaceutical processes4 CPPT9004 Reactor design and separation processes I

5 CPPT9005 Separation processes II6 CPPT9006 Material handling and drying7 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

StudentContactHours

Student Self Learning

(hr)

Assessment Mode

Total Student

Workload (hr)

ECTS

1CPPT9001

Lecture 24 76 AssignmentWritten

examination

100 5

2CPPT

9002


examination

100 5

3CPPT9003

Lecture 24 76 Assignment 100 5

4CPPT9004


examination

100 5

5CPPT9005


examination

100 5

6CPPT9006


7CPPT9007


examination

100 5

8CPPT9008


9CPPT9009


10CPPT9010


11CPPT9011


12CPPT9012


ProjectCPPT9013

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 and energy 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




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%




ECTS Credits

Module Code

Module Title

None CPPT9001-9012


Essential Reading:

Chemical Process Technology, J.A.Moulijn et al, Wiley, 2001Elementary 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, McGraw-Hill, 6th edition, 2001

Supplemental Reading:

Pharmaceuticals Vol. 1 – 4, Ed.J.McGuire, 2002, Wiley VCHUllmans Encyclopedia of Industrial Chemistry, 6th edition, Wiley – VCH, 2000Kirk-Othmer Encyclopedia of Chemical Technology, 4th edition, John Wiley, 1998Thermodynamics of Chemical Processes, G.J.Price, OUP, 1998Pharmaceutical Production, B. Bennett & G. Cole, IChemE, 2003 Chemical Process Technology, J.A.Moulijn et al, Wiley, 2001Elementary 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, 7th edition, McGraw Hill, 1997Engineering Thermodynamics, G. Rogers and Y. Mayhew, 4th edition, Longman, 1992CRC Handbook of Chemistry and PhysicsConcepts of Chemical Engineering for Chemists, Ed. SJR Simons, RSC, 2007

Web references, journals and other:

Pharmaceutical Technology EuropeJournal of Organic Process Research and DevelopmentChemical Engineering Progresshttp://www.rsc.org/lic/knovel_library.htmDublin Institute of Technology

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



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 ………………………….




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 process steps 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




ECTS Credits

Module Code

Module 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 = mcpΔT Heat exchange equipment and heat transfer fluids. Types of fluids




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, 1999Chemical Process Technology, J.A.Moulijn et al, Wiley, 2001Elementary Principles of Chemical Processes, R.M.Felder and R.W.Rousseau, John Wiley and Sons, 3rd edition, 2000Introduction to Heat Transfer, F.P, Incropera et al, 4th edition, John Wiley, 2002




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, 1997Radiation Heat Transfer, H.Jones, OUP, 2000Perrys Chemical Engineers Handbook, R. H. Perry and D. W. Green, 7th edition, McGraw Hill, 1997Engineering Thermodynamics, G. Rogers and Y. Mayhew, 4th edition, Longman, 1992Thermodynamics of Chemical Processes, G.J.Price, OUP, 1998Chemical Engineering: Volume1,J. M. Coulson, J. F. Richardson et al,Butterworth-Heinemann,6th edition, 1999CRC Handbook of Chemistry and PhysicsWeb references, journals and other:

Pharmaceutical Technology EuropeChemical Engineering Progresshttp://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


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




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 chemical and pharmaceutical production processes

To understand the differences in physical properties of components that are exploited in separation 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 graphical method.

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




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.Dublin Institute of Technology



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, 2001Chemical Engineering: Volume1, J. M. Coulson, J. F. Richardson et al, Butterworth-Heinemann, 6th edition, 1999Separation Process Principles, J.D.Seader et al, Wiley, 1998




ECTS Credits

Module Code

Module Title

None CPPT9001-9012



Encyclopedia of Separation Technology, D. M. Ruthren (ed), Wiley NY, 1997Chemical Engineering: Volume 2J. M. Coulson, J. F. Richardson et al,Butterworth-Heinemann,5th edition, 2000Handbook of Separation Process Technology, R.W.Rousseau, Wiley, 1987Handbook of Separation Techniques for Chemical Engineers, P. A. Schweitzer, McGraw-Hill, 1997Solvent Recovery Handbook, I. Smallwood, Blackwell, 2002Handbook of Batch Process Design, P. N. Sharrat (ed), Chapman and Hall/Blackie, 1997Encyclopedia of Separation Technology, D. M. Ruthren (ed), Wiley NY, 1997Chemical 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, 1987Handbook of Separation Techniques for Chemical Engineers, P. A. Schweitzer, McGraw-Hill, 1997Solvent Recovery Handbook, I. Smallwood, Blackwell, 2002

Web references, journals and other:http://webbook.nist.gov/

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


http://webbook.nist.gov/




ECTS Credits

Module Code

Module Title

None CPPT9001-9012

5 CPPT9004 Reactor design and separation processes I


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 design calculations 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




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.




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, 2001Separation Process Principles, J.D.Seader et al, Wiley, 1998




ECTS Credits

Module Code

Module Title

None CPPT9001-9012



Chemical Engineering: Volume3Ed. J. F. Richardson and D. G. Peacock,Butterworth-Heinemann,3rd edition, 1994Modelling of Chemical Kinetics and Reactor Design,A.Kayode Coker, Gulf Professional Publishing, 2001Chemical Reaction Engineering, I.S.Metcalfe, OUP, 1997Handbook of Batch Process Design, P. N. Sharrat (ed), Chapman and Hall/Blackie, 1997Chemical Reaction and Reactor Design, H. Tominaga and M. Tamaki, Wiley, 1997The Engineering of Chemical Reactions, L. D. Schmidt, OUP, 1998Chemical Reaction Engineering, O. Levenspiel, Wiley, 1999Chemical Reactor Development from Lab Synthesis to Industrial Production, D. Thoenes, Kluwer Academic Press, 1994Handbook of Solvent Extraction, eds. T. C. Lo et al, John Wiley, 1983Handbook of Solvent Extraction, ed. C.Hanson, 1991 Principles & Practice of Solvent Extraction, J. Rydberg, Marcel Dekker, 1992Chemical Engineering: Volume 2J. M. Coulson, J. F. Richardson et al,Butterworth-Heinemann,5th edition, 2000Handbook of Separation Process Technology, R.W.Rousseau, Wiley, 1987Handbook of Separation Techniques for Chemical Engineers, P. A. Schweitzer, McGraw-Hill, 1997Solvent Recovery Handbook, I. Smallwood, Blackwell, 2002Web references, journals and other:http://webbook.nist.gov/Further Details:

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


http://webbook.nist.gov/




ECTS Credits

Module Code

Module Title

None CPPT9001-9012

5 CPPT9005 Separation processes II


Module Description:

This module examines separation processes commonly used in the pharmaceutical industry. 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.




ECTS Credits

Module Code

Module Title

None CPPT9001-9012


Learning and Teaching Methods: 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




ECTS Credits

Module Code

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, 2000Perry's Chemical Engineers' Handbook, R.H. Perry, D.W. Green, McGraw Hill, 7th edition, 1998From Molecules to Crystallisers, R.J.Davey et al, OUP, 2001Separation and Purification by Crystallisation, G. D. Botsaris and K. Toyokura, ACS, 1997Crystal Growth of Organic Materials, A. Myerson et al, ACS, 1996Crystallisation, J. Mullin, Butterworth – Heinemann, 1997Physical 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, 1999Powders and Solids, Ed. W. Hoyle, RSC, 2001Handbook 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




ECTS Credits

Module Code

Module Title

None CPPT9001-9012


Crystal Growth of Organic Materials, A. Myerson et al, ACS, 1996Crystallisation, J. Mullin, Butterworth – Heinemann, 1997Separations Technology: Pharmaceutical and Biotechnology Applications, W. P. Olson, CRC, 1995Powder Technology and Pharmaceutical Processes, ed. D. Chulia et al, Elsevier, 1993

Web references, journals and other: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


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




ECTS Credits

Module Code

Module Title

None CPPT9001-9012

5 CPPT9006 Material handling and drying


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 chemical and pharmaceutical processes.To understand the characteristics of particulate solids, how they can be conveyed and stored, 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




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

Learning and Teaching Methods: 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




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 2J. M. Coulson, J. F. Richardson et al,Butterworth-Heinemann,5th edition, 2000




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, 2000Powders and Solids, Ed. W. Hoyle, RSC, 2001Handbook of Conveying and Handling of Particulate Solids (Handbook of Powder Technology),A. Levy (Editor), H. Kalman (Editor) 2001Separations Technology: Pharmaceutical and Biotechnology Applications, W. P. Olson, CRC, 1995Powder 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, 1996Materials Handling Handbook, D.E.Mulcahy, McGraw Hill, 1999Membrane Processes: A Technology Guide, P. T. Cardew and M. S. Le, RSC, 1998Membrane 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 and Pharmaceutical Sciences and the School of Control Systems and Electrical Engineering.

24 contact hours






ECTS Credits

Module Code

Module Title

None CPPT9001-9012

5 CPPT9007 Process control

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:


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 program to 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 be combined and tuned to produce effective controllers.




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 derivative are implemented in the PLC.

List the primary features of a SCADA software package and explain how they are of 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 automation equipment 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 that is automated using a PLC.

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

Learning and Teaching Methods: 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




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 and information 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.




ECTS Credits

Module Code

Module Title

None CPPT9001-9012


Web references, journals and other:http://www.controleng.comhttp://student.dit.ie/eng/staff/

Further Details:

24 contact hours


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 support services, material handling 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

chemical and pharmaceutical processes.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

pharmaceutical processes know and understand how plant services and utilities operate in chemical and

pharmaceutical processes 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

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





none CPPT9001-9012


Module content:HazardsRisk assessmentLegislationOccupational hygiene issuesContainment of hazardous substancesClean room technologyHazardous processesPlant design and process designEnvironmental impactPollution controlStorage of fluids and solids Transportation and metering of fluidsTransportation of solidsInformation sourcesCooling water systemsSteam distribution systemsOther heat transfer fluid systemsNitrogen and inert gas systemsVacuum systemsHVACWater treatment systemsAirHealth and safety legislation.Chemical safety.Hazard identification: HAZOPS etcThermal hazardsSafety equipmentHazardous area classificationStorage

Module Assessment: Assignment (100%)





none CPPT9001-9012


Essential Reading: Unit Operations in Chemical Engineering,W. McCabe, J. Smith and P. Harriott,McGraw-Hill, 6th edition, 2001Chemical Engineering: Volume3Ed. J. F. Richardson and D. G. Peacock,Butterworth-Heinemann,3rd edition, 1994Chemical Engineering: Chemical Engineering Design Volume 6, R. K. Sinnott, 3rd edition, Butterworth-Heinemann, 1999Hazard Identification Methods, F. Crawley & B. Tyler, IChemE, 2003HAZOP: A Guide to Best Practice, B. Tyler et al, 2000

Supplemental Reading: Safe Handling of Chemicals, Vol.1 – 3, P.A.Carson and C.J.Mumford, Longman, 1996Materials Handling Handbook, D.E.Mulcahy, McGraw Hill, 1999Hazardous Chemicals Handbook, P.A.Carson and C.J.Mumford, Butterworths, 2002Perry'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, 1997Process Safety Analysis – An Introduction, R. Skelton, I Chem E, 1997Safe Handling of Chemicals in Industry, R. A. Carson and C. J. Mumford, Longman, 1988Brethericks Handbook of Reactive Chemical Hazards, P. G. Urban, Butterworth Heinemann, 1995Safety Assessment for Chemical Processes, J. Steinbach, Wiley – VCH Weinheim, 1998Safety in the Process Industries, R. King, Butterworth, 2nd edition, 1998Hazop and Hazan: Identifying and Assessing Process Industry Hazards, T.A.Kletz, Hemisphere Pub. , 4th edition, 1999ISPE vol. 4: Water and Steam Systems, 2001Containment Systems: A Design Guide, N. Hirst et al, IChemE, 2002





none CPPT9001-9012


Web references, journals and other:www.hsa.ie

Further Details: contact hours - 24


http://www.hsa.ie/





none CPPT9001-9012


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

Learning and Teaching Methods: 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 flowsheetsFlowsheet simulationProcess optimisation.Product quality.Material handling.Process control.Regulatory issues.PATCase studies.Module Assessment: Assignment (100%)





none CPPT9001-9012


Essential Reading: Practical Process Research and Development, N.G.Anderson, Academic Press, 2000Chemical Engineering: Chemical Engineering Design Volume 6, R. K. Sinnott, 3rd edition, Butterworth-Heinemann, 1999EC Guide to GMP – Revision to Annex 1 (Eudralex Guide)Supplemental Reading: Journal Organic Process Research and Development, 1997 –Process Development, S. Lee and G. Robinson, OUP, 1995Process Plant Design, J. R. Backhurst and J. H. Harker, Heinemann, 1981Process Development, J.Atherton, OUP, 1999Top Drugs: Top Synthetic Routes, J.Saunders, OUP, 2000ISPE Baseline Pharmaceutical Engineering Guides Vol. 1 Bulk Pharmaceutical Chemicals Baseline Guide, 1996Pilot Plants and Scale Up of Chemical Processes, W. Hoyle, RSC, 1997Principle of Process Research and Chemical Development in the Pharmaceutical Industry, O. Repic, Wiley Interscience, 1998Pharmaceutical Production Facilities – Design and Applications, G. M. Cole, Taylor and Francis, 2nd edition, 1998 Scale Up Methodology for Chemical Processes, J. P. Euzen et al, Technip Paris 1993Handbook of Chemical Process and Design, J. Speight, McGraw-Hill, 2001The Pilot Plant Real Book, F. X. McConville, FXM Eng & Des, 2002Pharmaceutical Engineering Vol. 1 – 12, Edwards, Butterworth Heinemann, 2005Encyclopedia of Pharmaceutical Technology, J. Swarbrick, Marcel Dekker, 2002Product and Process Design Principles, W. D. Seider et al, 2nd edition, Wiley, 2003

Web references, journals and other:http://www.rsc.org/lic/knovel_library.htmPharmaceutical Technology EuropeJournal of Organic Research and Development

Further Details: Contact hours - 24.


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





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 facilityLearning and Teaching Methods: 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.GEPDesign of pharmaceutical finish facilities. Solid dosage forms. Blending, granulation, milling etcLiquids. Aseptic processing.Clean room technologyProcess support servicesFormulation science & technology

Module Assessment:

Assignment (100%)





none CPPT9001-9012

5 CPPT9010 Facility design and operation.

Essential Reading: ISPE Baseline Guide vol. 3 Sterile Manufacturing Facilities, 1999ISPE Vol. 2 Oral Solid Dosage Forms, 1998

Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice (FDA)ASME BPE 2002EUDRALEX Volume 4 - Medicinal Products for Human and Veterinary Use : Good Manufacturing PracticeEC Guide to GMP – Revision to Annex 1 (Eudralex Guide)Introduction to Contamination Control and Cleanroom Technology, M. Ramstorp, Wiley-VCH, 2000Containment Systems: A Design Guide, N. Hirst et al, IChemE, 2002Supplemental Reading: Pharmaceutical Production Facilities – Design and Applications, G. M. Cole, Taylor and Francis, 2nd edition, 1998 Pharmaceutical Engineering Vol. 1 – 12, Edwards, Butterworth Heinemann, 2005Encyclopedia of Pharmaceutical Technology, J. Swarbrick, Marcel Dekker, 2002Health and Safety at Work Regulations 2006.FDA (especially CFR part 11 guidelines,)

Web references, journals and other:http://www.rsc.org/lic/knovel_library.htmhttp://www.fda.govPharmaceutical Tecechnology Europe



http://www.fda.gov/






none CPPT9001-9012


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 environmental legislation.

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

understand the principles of project management know how project management techniques are used in chemical and

pharmaceutical processes 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





none CPPT9001-9012


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 environmental

management 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

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

Module content:Characteristics of a projectProject life cyclePrinciples of project managementProject management functionsRole of project managerScope managementLessons from ‘real life’Structure and organisation

Costs and cost factorsPrices and competitionEvaluation 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.





none CPPT9001-9012


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 legislationWater pollution legislationNoise pollution legislationEnvironmental Impact Assessment, Council Directive 85/337.Council Directive 97/11/EC.EC (EIA) Regulations, 1989 and1994.Waste Management legislationEnvironmental 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.


Essential Reading: A Guide to the Project Management Body of Knowledge, Project Management Institute, 2000





none CPPT9001-9012


Engineering Economics and Cost Analysis,C.A.Collier, Harlow: Addison-Wesley,3rd Edition, 1998

Environmental Management, C. J. Barrow, Routledge, 1999Installing Environmental Management Systems, C. Sheldon and M. Yoxon, Earthscan, 2001Pollution Causes, Effects and Control, Ed. R. M. Harrison, 4th edition, RSC, 2001Environmental Management Principles and Practice, C. J. Barrow, Routledge, 1999Environmental Management Tools for SME’s, Ed. R. Starkey, EEA, 1998Environmental Policy, Legislation and Practices, K.T.Cullen, 2000Supplemental Reading: Project Management-A Systems Approach to Planning, Scheduling and Controlling, H.Kerzner, 7th editionThe Handbook of Project Management, T.L.YoungPrinciple of Engineering Analysis,J.A.White, M.H.Agee and K.E.CaseJohn Wiley and Sons3rd edition, 1989Principles of Engineering Economy,E.L.Grant, W.G.Ireson and R.S.Leavenworth,John Wiley and sons8th edition, 1990 Environmental Management in Practice, Vol.1, Ed. B. Nath et al, Routledge, 1998Handbook of Environmental Management and Technology, G. Holmes, B. R. Singh, L. Theodore, John Wiley, 1993ISO 14001ISO 14004Pollution Prevention for Chemical Processes, D. T. Allen, John Wiley and Sons, 1997Air 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, 2000Croners Waste Management, Croner Publications, London, 1991Control of VOC Emissions: Conventional and Emerging Technologies, P. Hunter, S. T. Oyama, Wiley NY, 2000Management of Process Industry Waste, Ed. D. Bahu, B. Crittenden, J. O’Hara, Inst. of Chem. Eng., 1997





none CPPT9001-9012


Waste Minimisation: A Chemists Approach, Ed. Martin and Bastock, RSC, 1994Chemistry of Waste Minimisation, J. H. Clark (ed) Blackie/Chapman and Hall, 1995Environmental Management in Practice, Eds. B. Nath, L. Hens, P. Compton, D. Devuyst, Routledge, 1998 Vol.1Risk 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

Web references, journals and other:http://www.rsc.org/lic/knovel_library.htmwww.boc.iewww.epa.ie



http://www.epa.ie/

http://www.boc.ie/






none CPPT9001-9011

5 CPPT9012 Regulatory aspects, GMP and 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 the manufacture and sale of pharmaceuticals in Ireland the EU and the US.


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

pharmaceuticals in 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 inspectionValidation overview





none CPPT9001-9011

5 CPPT9012 Regulatory aspects GMP and process validation.

Validation Master PlanCommissioning and Equipment QualificationProcess ValidationComputer systems validationCleaning validationDocumentationPharmaceutical legislation that regulates the pharmaceutical industry in Ireland, EU and US.The documents that are required to support this regulation and maintain a company in a compliant state


Essential Reading: The Rules Governing Medicinal Products in the European Union. Volume 4, Guide to Good manufacturing practice in the Pharmaceutical industry, US Code of Federal Regulations –CFR title 21,Food and DrugsPharmaceutical Process Validation, Eds. I.Berry and R.Nash, Marcel Dekker, 1993European Commmission Directive 91/365/EECThe Rules Governing Medicinal Products in the European Union. US Code of Federal Regulations –CFR title 21,Food and DrugsSupplemental Reading: Good Manufacturing Practice – A Guide to Practical Quality Management, P. Uys, Knowledge Resources, 1994ISPE Baseline Pharmaceutical Engineering Guides Vol. 1, 1996Validation of Bulk Pharmaceutical Chemicals, I. R. Berry and D. Harpaz, Interpharm, 1997Biopharmaceutical Process Validation, Eds. G. Sofer et al, Marcel Dekker Inc. 2000Web references, journals and other:Journal of Validation TechnologyFurther Details: Contact hours - 24.






none CPPT9001 - 9012

30 CPPT9013 Project

Module author: Paul Ashall.Module Description: Research projectModule 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

interaction and communication skills. To promote innovation.


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.

Learning and Teaching Methods: Project based learningSelf directed studyWorkshops

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.





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

Supplemental Reading: 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 PublicationsMarshall, 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 performed

internally.

(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 600Project/dissertation 1 300

900

Course journal list

Chemical Engineer

Chemical Engineering Progress

Chemical and Engineering News

Organic Process Research and Development

Pharmaceutical Technology Europe

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.

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