PHRM06006 2019 Manufacturing and Processing Technology
Pharmaceutical Processing Technology details the diverse array of manufacturing processes & equipment employed in the pharmaceutical industry, in combination with the product packaging techniques and material selection criteria used for each formulation type.
Learning Outcomes
On completion of this module the learner will/should be able to;
Understand the process of chemical dispensing, methods and equipment.
To describe the cleaning requirements of process equipment and methods employed by industry to combat this requirement.
To detail the mainstream systems and equipment used for generation of EP and USP grade water for Pharm/Biopharma production and manufacture.
To demonstrate a knowledge of the various information technology applications operating in the pharmaceutical industry.
To demonstrate how non sterile Pharma/cosmetic products are manufactured, processed and the packaging options/requirements suited to each type of formulation.
To demonstrate a knowledge of the methods for biologic manufacture, purification and primary fill/packaging requirements for this type formulation.
To describe the methods to ensure the sterility of pharmaceutical preparation to the point of primary container closure selection and processing.
Clear knowledge of solid dosage form, from dry powder mixing to final dosage and the packaging methods and requirements.
Teaching and Learning Strategies
.
Module Assessment Strategies
.
Repeat Assessments
.
Indicative Syllabus
Dispensing/starting material allocation
Batch Records - documentation, labeling (RFID), weighing, LAF
Solid dosage form - Tableting - Ingredient (make up) Mixing, granulation, compression, coating, blister packs
Liquids sterile, Parenterals - Formulation, Sterile manufacture, filtration, filling, packaging BFS, Terminal sterilization ETO
Biologics - Fermentation, scale up, harvesting, disruption, filtration, filling, lyophilization, packaging Vials
Non sterile - Ingredients, Creams, gels, liquids (susp, emuls), mixing, milling, filling (tubes plastic, alu, bottles glass, plastic, sachet), packaging
Computerised system control. - Scada, PLCs, EBMR, ERP
Manufacture of Class I, II and III Medical Devices
Introduction to materials used in medical device manufacture. Overview of molding design and extruded medical plastic manufacturing processes. Manufacturing flow diagrams.
Purified Water systems -Organic Scavanger, Twin bed Deioniser, UF, RO, CDI, TCS, Ozonation, UV. Filtration, Carbon, depth, mixed membrane.
Cleaning systems,
Detergents, CIP, SIP, sanitation
Coursework & Assessment Breakdown
Coursework Assessment
Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
---|---|---|---|---|---|---|
1 | Presentation on processing technology | Formative | UNKNOWN | UNKNOWN % | OnGoing | 1,2,3,7,8 |
2 | Short answer questions/multiple choice questions/assignment work | Coursework Assessment | UNKNOWN | 40 % | OnGoing | 1,2,3,4,5,6,7,8 |
End of Semester / Year Assessment
Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
---|---|---|---|---|---|---|
1 | Final Exam | Final Exam | Open Book Exam | 60 % | End of Term | 1,2,3,4,5,6,7,8 |
Part Time Mode Workload
Type | Location | Description | Hours | Frequency | Avg Workload |
---|---|---|---|---|---|
Lecture | Not Specified | Lecture | 4 | Weekly | 4.00 |
Module Resources
Pharmaceutical packaging technology. London ; New York : Taylor & Francis, 2000
Pharmaceutical production facilities design and applications. Cole, Graham. London ; New York : Taylor & Francis, 2000.
Encyclopaedia of pharmaceutical technology second edition, 2004, J. Swarbrick.
EC Directive 92/27/EEC for labels and leaflets
None
None
None