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 OSullivan, 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 Dr. M.B.Foley Dr. H. Ali Mr. P.Ashall Mr. Gavin Duffy Student Rep. Programme Tutors P. Ashall, G. Duffy, H. Ali, C. McDonnell, A. Greene Programme Director Head of School

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) (v) (vi) (vii) (viii) (ix) Provision of high quality industrially relevant education and training by experts from academia and industry The teaching of proposed modules and related topics designed to enhance the knowledge and skills of students in these areas To provide a broad programme consistent with the graduate intake and programme objectives Provision of appropriate assessments and assignments to promote, reinforce and test learning To deliver modules and topics suitable for continuing professional development 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) (xi) (xii) (xiii)

To deliver a programme which will enable graduates to work effectively with engineers and other professions in solving plant operating problems To enhance the students ability to exploit work-based learning and self-directed learning To develop research skills 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.) 6 hours

Semester 1 (Yr 13 weeks 1) Semester 2 (Yr 13 weeks 6 hours 1) Semester 1 (Yr 13 weeks 6 hours 2) Semester 2 (Yr 13 weeks 6 hours 2) 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 1 2 3 4 5 6 7 8 9 10 11 12 13 Code CPPT9001 CPPT9002 CPPT9003 CPPT9004 CPPT9005 CPPT9006 CPPT9007 CPPT9008 CPPT9009 CPPT9010 CPPT9011 CPPT9012 CPPT9013 Title Pharmaceutical processes basic principles Heat transfer and fluids Mass transfer applications in pharmaceutical processes Reactor design and separation processes I Separation processes II Material handling and drying Process control Process utilities et al Process design and development Facility design and operation Management aspects of pharmaceutical production Regulatory aspects, GMP and process validation Project

Detailed Programme Structure Module Delivery Method Lecture Lecture Lecture Lecture Lecture Lecture Lecture Lecture Lecture Lecture Lecture Lecture Industry/ work Based Student Student Self Assessment Contact Learning Mode Hours (hr) 24 24 24 24 24 24 24 24 24 24 24 24 76 76 76 76 76 76 76 76 76 76 76 76 Assignment Written examination Assignment Written examination Assignment Assignment Written examination Assignment Written examination Assignment Assignment Written examination Assignment Assignment Assignment Assignment Assignment Thesis Total Student Workload (hr) 100 100 100 100 100 100 100 100 100 100 100 100 600 1800 5 5 5 5 5 5 5 5 5 5 30 90 ECTS

1 CPPT 9001 2 CPPT 9002 3 CPPT 9003 4 CPPT 9004 5 CPPT 9005 6 CPPT 9006 7 CPPT 9007 8 CPPT 9008 9 CPPT 9009 10 CPPT 9010 11 CPPT 9011 12 CPPT 9012 Project CPPT 9013 TOTAL

5 5

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 incourse. 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 PreRequisite Modules code(s) None CoRequisite Modules code(s) CPPT90019012 ECTS Credits 5 Module Code CPPT9001
Module Title

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

Dublin Institute of Technology PreRequisite Modules code(s) None CoRequisite Modules code(s) CPPT90019012 ECTS Credits 5 Module Code CPPT9001
Module Title

Pharmaceutical Processes

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%

Dublin Institute of Technology PreRequisite Modules code(s) None CoRequisite Modules code(s) CPPT90019012 ECTS Credits 5 Module Code CPPT9001
Module Title

Pharmaceutical Processes

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, McGrawHill, 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, 2000 Unit 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, 1999 Perrys Chemical Engineers Handbook, R. H. Perry and D. W. Green, 7th edition, McGraw Hill, 1997 Engineering Thermodynamics, G. Rogers and Y. Mayhew, 4th edition, Longman, 1992 CRC Handbook of Chemistry and Physics Concepts of Chemical Engineering for Chemists, Ed. SJR Simons, RSC, 2007 Web references, journals and other: Pharmaceutical Technology Europe Journal of Organic Process Research and Development Chemical Engineering Progress http://www.rsc.org/lic/knovel_library.htm

Dublin Institute of Technology PreRequisite Modules code(s) None CoRequisite Modules code(s) CPPT90019012 ECTS Credits 5 Module Code CPPT9001
Module Title

Pharmaceutical Processes

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

Date of Academic Council approval .

Dublin Institute of Technology PreRequisite Modules code(s) None CoRequisite Modules code(s) CPPT90019012 ECTS Credits 5 Module Code CPPT9002
Module Title

Heat transfer and fluid flow

Module author: Gavin Duffy/Paul Ashall/Hassan Ali 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

Dublin Institute of Technology PreRequisite Modules code(s) None CoRequisite Modules code(s) CPPT90019012 ECTS Credits 5 Module Code CPPT9002
Module Title

Heat transfer and fluid flow

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 = UAlmtd Energy balance. Q = mcpT Heat exchange equipment and heat transfer fluids. Types of fluids

Dublin Institute of Technology PreRequisite Modules code(s) None CoRequisite Modules code(s) CPPT90019012 ECTS Credits 5 Module Code CPPT9002
Module Title

Heat transfer and fluid flow

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% End of module written examination 50% Essential Reading: Introduction to Heat Transfer, F.P, Incropera et al, 4th edition, John Wiley, 2002 Unit Operations in Chemical Engineering, W. McCabe, J. Smith and P. Harriott, McGrawHill, 6th edition, 2001 Chemical Engineering: Volume1, J. M. Coulson, J. F. Richardson et al, ButterworthHeinemann, 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

Dublin Institute of Technology PreRequisite Modules code(s) None CoRequisite Modules code(s) CPPT90019012 ECTS Credits 5 Module Code CPPT9002
Module Title

Heat transfer and fluid flow

Supplemental Reading: Heat Transfer (Oxford University Primers), R.H.S.Winterton, Oxford University Press, 1997 Two Phase Flow and Heat Transfer, P.B.Whalley, OUP, 1997 Radiation Heat Transfer, H.Jones, OUP, 2000 Perrys Chemical Engineers Handbook, R. H. Perry and D. W. Green, 7th edition, McGraw Hill, 1997 Engineering Thermodynamics, G. Rogers and Y. Mayhew, 4th edition, Longman, 1992 Thermodynamics of Chemical Processes, G.J.Price, OUP, 1998 Chemical Engineering: Volume1,J. M. Coulson, J. F. Richardson et al,ButterworthHeinemann,6th edition, 1999 CRC Handbook of Chemistry and Physics Web references, journals and other: Pharmaceutical Technology Europe 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

Date of Academic Council approval .

Dublin Institute of Technology PreRequisite Modules code(s) None CoRequisite Modules code(s) CPPT90019012 ECTS Credits 5 Module Code CPPT9003
Module Title

Mass transfer applications

Module author: Gavin Duffy/Paul Ashall/Hassan Ali 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: On completion of this module, the learner will be able to. Define the basic principles of mass transfer as applied to chemical and pharmaceutical processes

Dublin Institute of Technology PreRequisite Modules code(s) None CoRequisite Modules code(s) CPPT90019012 ECTS Credits 5 Module Code CPPT9003
Module Title

Mass transfer applications

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

Learning and Teaching Methods: 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 PreRequisite Modules code(s) None CoRequisite Modules code(s) CPPT90019012 ECTS Credits 5 Module Code CPPT9003
Module Title

Mass transfer applications

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

Dublin Institute of Technology PreRequisite Modules code(s) None CoRequisite Modules code(s) CPPT90019012 ECTS Credits 5 Module Code CPPT9003
Module Title

Mass transfer applications

Supplemental Reading: 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, McGrawHill, 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, McGrawHill, 1997 Solvent 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

Date of Academic Council approval .

Dublin Institute of Technology PreRequisite Modules code(s) None CoRequisite Modules code(s) CPPT90019012 ECTS Credits 5 Module Code CPPT9004
Module Title

Reactor design and separation processes I

Module author: Gavin Duffy/Paul Ashall/Hassan Ali 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: On completion of this module, the learner will be able to. 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

Dublin Institute of Technology PreRequisite Modules code(s) None CoRequisite Modules code(s) CPPT90019012 ECTS Credits 5 Module Code CPPT9004
Module Title

Reactor design and separation processes I

Learning and Teaching Methods: 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.

Dublin Institute of Technology PreRequisite Modules code(s) None CoRequisite Modules code(s) CPPT90019012 ECTS Credits 5 Module Code CPPT9004
Module Title

Reactor design and separation processes I

Equipment. Modes of operation. Extractants. Examples. Design calculations. Process modelling

Laboratory (2) Reactor operation Liquid/liquid extraction

Module Assessment Assignment and laboratory 50% End of module written examination 50%

Essential Reading: Chemical Reactor Theory: An Introduction, K.G. Denbigh and J.C.R. Turner, 3rd Edition, Cambridge University Press, 1984 Unit Operations in Chemical Engineering, W. McCabe, J. Smith and P. Harriott, McGrawHill, 6th edition, 2001 Separation Process Principles, J.D.Seader et al, Wiley, 1998

Dublin Institute of Technology PreRequisite Modules code(s) None CoRequisite Modules code(s) CPPT90019012 ECTS Credits 5 Module Code CPPT9004
Module Title

Reactor design and separation processes I

Supplemental Reading: 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, 2001 Chemical Reaction Engineering, I.S.Metcalfe, OUP, 1997 Handbook of Batch Process Design, P. N. Sharrat (ed), Chapman and Hall/Blackie, 1997 Chemical 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, 1999 Chemical 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, 1991 Principles & Practice of Solvent Extraction, J. Rydberg, Marcel Dekker, 1992 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, McGrawHill, 1997 Solvent 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. 24 contact hours

Date of Academic Council approval .

Dublin Institute of Technology PreRequisite Modules code(s) None CoRequisite Modules code(s) CPPT90019012 ECTS Credits 5 Module Code CPPT9005
Module Title

Separation processes II

Module author: Gavin Duffy/Paul Ashall/Hassan Ali 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: On completion of this module, the learner will be able to. 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.

Dublin Institute of Technology PreRequisite Modules code(s) None CoRequisite Modules code(s) CPPT90019012 ECTS Credits 5 Module Code CPPT9005
Module Title

Separation processes II

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

Dublin Institute of Technology PreRequisite Modules code(s) None CoRequisite Modules code(s) CPPT90019012 ECTS Credits 5 Module Code CPPT9005
Module Title

Separation processes II

Module Assessment Assignment and laboratory 50% End of module written examination 50%

Essential Reading: Unit Operations in Chemical Engineering, W. McCabe, J. Smith and P. Harriott, McGrawHill, 6th edition, 2001 Supplemental Reading: 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, 1995 Chemical 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 Chemical 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) 2001 Separation and Purification by Crystallisation, G. D. Botsaris and K. Toyokura, ACS, 1997

Dublin Institute of Technology PreRequisite Modules code(s) None CoRequisite Modules code(s) CPPT90019012 ECTS Credits 5 Module Code CPPT9005
Module Title

Separation processes II

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

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

Date of Academic Council approval .

Dublin Institute of Technology PreRequisite Modules code(s) None CoRequisite Modules code(s) CPPT90019012 ECTS Credits 5 Module Code CPPT9006
Module Title

Material handling and drying

Module author: Gavin Duffy/Paul Ashall/Hassan Ali 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: On completion of this module, the learner will be able to. 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

Dublin Institute of Technology PreRequisite Modules code(s) None CoRequisite Modules code(s) CPPT90019012 ECTS Credits 5 Module Code CPPT9006
Module Title

Material handling and drying

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

Dublin Institute of Technology PreRequisite Modules code(s) None CoRequisite Modules code(s) CPPT90019012 ECTS Credits 5 Module Code CPPT9006
Module Title

Material handling and drying

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 Assignment and laboratory 100%

Essential Reading: Unit Operations in Chemical Engineering, W. McCabe, J. Smith and P. Harriott, McGraw-Hill, 6th edition, 2001 Supplemental Reading: Chemical Engineering: Volume 2 J. M. Coulson, J. F. Richardson et al, Butterworth-Heinemann, 5th edition, 2000

Dublin Institute of Technology PreRequisite Modules code(s) None CoRequisite Modules code(s) CPPT90019012 ECTS Credits 5 Module Code CPPT9006
Module Title

Material handling and drying

Perry's Chemical Engineers' Handbook, R.H. Perry, D.W. Green, McGraw Hill, 7th edition, 1998 Chemical 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, 1993 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 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

Web references, journals and other: http://www.nzifst.org.nz/unitoperations/index.htm 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

Date of Academic Council approval .

Dublin Institute of Technology PreRequisite Modules code(s) None CoRequisite Modules code(s) CPPT90019012 ECTS Credits 5 Module Code CPPT9007
Module Title

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: 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 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.

Dublin Institute of Technology PreRequisite Modules code(s) None CoRequisite Modules code(s) CPPT90019012 ECTS Credits 5 Module Code CPPT9007
Module Title

Process control

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

Dublin Institute of Technology PreRequisite Modules code(s) None CoRequisite Modules code(s) CPPT90019012 ECTS Credits 5 Module Code CPPT9007
Module Title

Process control

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. Supplemental Reading: Introduction to Control System Technology, Bateson, R. N. Dublin Institute of Technology

PreRequisite Modules code(s) None

CoRequisite Modules code(s) CPPT90019012

ECTS Credits 5

Module Code CPPT9007

Module Title

Process control

Web references, journals and other: http://www.controleng.com http://student.dit.ie/eng/staff/ Further Details: 24 contact hours

Date of Academic Council approval .

Dublin Institute of Technology

Pre-requisite modules codes none

Co-requisite modules codes CPPT90019012

ECTS Credits 5

Module code CPPT9008

Module title 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

Dublin Institute of Technology Pre-requisite modules codes none Co-requisite modules codes CPPT90019012 ECTS Credits 5 Module code CPPT9008 Module title Process utilities, process support services, material handling and process safety

Module content: Hazards Risk assessment Legislation Occupational hygiene issues Containment of hazardous substances Clean room technology Hazardous processes Plant design and process design Environmental impact Pollution control Storage of fluids and solids Transportation and metering of fluids Transportation of solids Information sources Cooling water systems Steam distribution systems Other heat transfer fluid systems Nitrogen and inert gas systems Vacuum systems HVAC Water treatment systems Air Health and safety legislation. Chemical safety. Hazard identification: HAZOPS etc Thermal hazards Safety equipment Hazardous area classification Storage Module Assessment: Assignment (100%)

Dublin Institute of Technology Pre-requisite modules codes none Co-requisite modules codes CPPT90019012 ECTS Credits 5 Module code CPPT9008 Module title Process utilities, process support services, material handling and process safety

Essential Reading: Unit Operations in Chemical Engineering, W. McCabe, J. Smith and P. Harriott, McGraw-Hill, 6th edition, 2001 Chemical 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 Supplemental Reading: 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, 1998 Chemical 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, Butterworth Heinemann, 1995 Safety Assessment for Chemical Processes, J. Steinbach, Wiley VCH Weinheim, 1998 Safety in the Process Industries, R. King, Butterworth, 2nd 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, 2001 Containment Systems: A Design Guide, N. Hirst et al, IChemE, 2002

Dublin Institute of Technology Pre-requisite modules codes none Co-requisite modules codes CPPT90019012 ECTS Credits 5 Module code CPPT9008 Module title Process utilities, process support services, material handling and process safety

Web references, journals and other: www.hsa.ie Further Details: contact hours - 24

Date of Academic Council approval .

Dublin Institute of Technology Pre-requisite modules codes none Co-requisite modules codes CPPT90019012 ECTS Credits 5 Module code CPPT9009 Module title Process design and development

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 general P and I flowsheets Flowsheet simulation Process optimisation. Product quality. Material handling. Process control. Regulatory issues. PAT Case studies. Module Assessment: Assignment (100%)

Dublin Institute of Technology Pre-requisite modules codes none Co-requisite modules codes CPPT90019012 ECTS Credits 5 Module code CPPT9009 Module title Process design and development

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, 1999 EC 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, 1995 Process Plant Design, J. R. Backhurst and J. H. Harker, Heinemann, 1981 Process Development, J.Atherton, OUP, 1999 Top 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 and Francis, 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, 2001 The 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 Web references, journals and other: http://www.rsc.org/lic/knovel_library.htm Pharmaceutical Technology Europe Journal of Organic Research and Development Further Details: Contact hours - 24. Date of Academic Council approval .

Dublin Institute of Technology Pre-requisite modules codes none Co-requisite modules codes CPPT90019012 ECTS Credits 5 Module code CPPT9010 Module title 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 Learning 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. GEP Design of pharmaceutical finish facilities. Solid dosage forms. Blending, granulation, milling etc Liquids. Aseptic processing. Clean room technology Process support services Formulation science & technology Module Assessment:

Assignment (100%)

Dublin Institute of Technology Pre-requisite modules codes none Co-requisite modules codes CPPT90019012 ECTS Credits 5 Module code CPPT9010 Module title 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 Current Good Manufacturing Practice (FDA) ASME BPE 2002 EUDRALEX 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, WileyVCH, 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, 2nd edition, 1998 Pharmaceutical Engineering Vol. 1 12, Edwards, Butterworth Heinemann, 2005 Encyclopedia of Pharmaceutical Technology, J. Swarbrick, Marcel Dekker, 2002 Health and Safety at Work Regulations 2006. FDA (especially CFR part 11 guidelines,) Web references, journals and other: http://www.rsc.org/lic/knovel_library.htm http://www.fda.gov Pharmaceutical Tecechnology Europe Further Details: Contact hours - 24. Date of Academic Council approval .

Dublin Institute of Technology Pre-requisite modules codes none Co-requisite modules codes CPPT90019012 ECTS Credits 5 Module code CPPT9011 Module title 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 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

Dublin Institute of Technology Pre-requisite modules codes none Co-requisite modules codes CPPT90019012 ECTS Credits 5 Module code CPPT9011 Module title Management aspects 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 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 project Project life cycle Principles of project management Project management functions Role of project manager Scope management Lessons from real life Structure and organisation Costs and cost factors Prices and competition Evaluation of capital investment, payback period, average rate of return, discount cash flow and internal rate of return Environmental management systems. Environmental management principles. ISO 14001. EMAS. Waste treatment and disposal. Effluent treatment. Emissions to atmosphere.

Dublin Institute of Technology Pre-requisite modules codes none Co-requisite modules codes CPPT90019012 ECTS Credits 5 Module code CPPT9011 Module title Management aspects 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

Dublin Institute of Technology Pre-requisite modules codes none Co-requisite modules codes CPPT90019012 ECTS Credits 5 Module code CPPT9011 Module title Management aspects 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 SMEs, Ed. R. Starkey, EEA, 1998 Environmental Policy, Legislation and Practices, K.T.Cullen, 2000 Supplemental Reading: Project Management-A Systems Approach to Planning, Scheduling and Controlling, H.Kerzner, 7th edition The Handbook of Project Management, T.L.Young Principle of Engineering Analysis, J.A.White, M.H.Agee and K.E.Case John Wiley and Sons 3rd 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 14001 ISO 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, 2000 Waste 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. OHara, Inst. of Chem. Eng., 1997

Dublin Institute of Technology Pre-requisite modules codes none Co-requisite modules codes CPPT90019012 ECTS Credits 5 Module code CPPT9011 Module title Management aspects of pharmaceutical production

Waste Minimisation: A Chemists Approach, Ed. Martin and Bastock, RSC, 1994 Chemistry 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, 2000 Case Studies in Environmental Technology, P. N. Sharratt and M. Sparshott, I Chem E, 1998 The ISO 14000 EMS Audit Handbook, G. P. Johnson, St. Lucie Press, 1997 Web references, journals and other: http://www.rsc.org/lic/knovel_library.htm www.boc.ie www.epa.ie Further Details: Contact hours - 24.

Date of Academic Council approval .

Dublin Institute of Technology Pre-requisite modules codes none Co-requisite modules codes CPPT90019011 ECTS Credits 5 Module code CPPT9012 Module title 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.

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 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 inspection Validation overview

Dublin Institute of Technology Pre-requisite modules codes none Co-requisite modules codes CPPT90019011 ECTS Credits 5 Module code CPPT9012 Module title Regulatory aspects GMP and process validation.

Validation Master Plan Commissioning and Equipment Qualification Process Validation Computer systems validation Cleaning validation Documentation Pharmaceutical 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 Module Assessment: Assignment (100%) 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 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, 1996 Validation 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 Further Details: Contact hours - 24. Date of Academic Council approval .

Dublin Institute of Technology Pre-requisite modules codes none Co-requisite modules codes CPPT9001 9012 ECTS Credits 30 Module code CPPT9013 Module title Project

Module author: Paul Ashall. Module Description: Research project Module aims: The aim of this module is .. To enhance the quality of individual students 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. Learning Outcomes: On completion of this module, the learner will be able to. 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 learning Self 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.

Dublin Institute of Technology Pre-requisite modules codes none Co-requisite modules codes CPPT9001 9012 ECTS Credits 30 Module code CPPT9013 Module title 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 youre 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. Web references, journals and other: Further Details:

Date of Academic Council approval .

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) (ii) (iii) (iv) (a) Practical Performance Oral Presentation Thesis/dissertation Project plan (50 marks) (50 marks) (250 marks) (50 marks)

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 Taught Project/dissertation Number 12 1 Total Marks 600 300 900

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.