PHRM07008 2013 PHARMACEUTICAL PROCESSING AND MEDICAL DEVICE MANUFACTURE
Full Title
PHARMACEUTICAL PROCESSING AND MEDICAL DEVICE MANUFACTURE
Transcript Title
PHARMACEUTICAL PROCESSING
Code
PHRM07008
Attendance
N/A %
Subject Area
PHRM - Pharmaceutical Science
Department
ASCI - Applied Sciences
Level
07 - NFQ Level 7
Credit
05 - 05 Credits
Duration
Semester
Fee
€
Start Term
2013 - Full Academic Year 2013-14
End Term
2019 - Full Academic Year 2019-20
Author(s)
Tom Patton
Programme Membership
SG_SPHAR_J07 201300 Bachelor of Science in Pharmaceutical Science
Description
This module details the diverse array of manufacturing processes & equipment employed in the pharmaceutical industry, in combination with the product packaging techniques. Additionally it provide the student with a broad understanding of the various types of medical devices available and the modes and methods of manufacture.
Learning Outcomes
On completion of this module the learner will/should be able to;
1.
To detail the mainstream systems and equipment used for generation of EP and USP grade water for Pharm/Biopharma production and manufacture.
2.
To demonstrate a knowledge of the various information technology applications operating in the pharmaceutical industry.
3.
To distinguish how non sterile Pharma/cosmetic products are manufactured, processed and the packaging options/requirements suited to each type of formulation.
4.
To examine the methods for biologic manufacture, purification and primary fill/packaging requirements for this type formulation.
5.
To describe the methods to ensure the sterility of pharmaceutical preparation to the point of primary container closure selection and processing.
6.
Contrast solid dosage form production techniques, from dry powder mixing to finished dosage formation and the packaging methods and requirements.
7.
To appraise the cleaning requirements of process equipment and methods employed by industry to combat this requirement.
8.
Demonstrate a knowledge and understanding of the medical device industry and the main product types currently being manufactured.
9.
Explain the various principles and practices involved in the control and regulation of the medical device industry both in Europe and the USA.
10.
Compare and contrast the principal steps involved in the manufacturing of a range of different medical device products.
Module Dependencies
Prerequisites
None
Co-requisites
None
Incompatibles
None
Indicative Syllabus
- Batch Records - documentation, labelling (RFID), dispensing, LAF
- Solid dosage form - Tableting – Ingredients, 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 (suspensions, emulsions), mixing, milling, filling (tubes plastic, alu, bottles glass, plastic, sachet), packaging
- Computerised system control. - Scada, PLCs, EBMR, ERP
- 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.
- Introduction to Medical Device Manufacturing. Medical Device Classification and Certification.
- Typical Medical Devices and their Manufacturing Steps. Other support services for the manufacturing of Medical Devices.
Coursework & Assessment Breakdown
Coursework & Continuous Assessment
40 %
End of Semester / Year Formal Exam
60 %
Coursework Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | Presentation Presentation on processing technology | Continuous Assessment | UNKNOWN | 0 % | OnGoing | 1,2,3,4,5,6,7,8,9,10 |
| 2 | Assignment Short Answer Questions/Multiple Choice Questions/Assignment Work | Continuous Assessment | UNKNOWN | 40 % | OnGoing | 1,2,3,4,5,6,7,8,9,10 |
End of Semester / Year Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | Final Exam End of term exam | Final Exam | UNKNOWN | 60 % | End of Term | 1,2,3,4,5,6,7,8,9,10 |
Full Time Mode Workload
| Type | Location | Description | Hours | Frequency | Avg Workload |
|---|---|---|---|---|---|
| Lecture | Not Specified | Lecture | 3 | Weekly | 3.00 |
| Independent Learning | UNKNOWN | Self study | 4 | Weekly | 4.00 |
Total Full Time Average Weekly Learner Contact Time 3.00 Hours
Module Resources
Non ISBN Literary Resources
Cole, G., Pharmaceutical production facilities design and applications. (2nd Ed) Taylor & Francis, 2000. ISBN 0748404384, 9780748404384.
Swarbrick, J., Encyclopaedia of pharmaceutical technology (4th Ed), Informa Healthcare, 2007. ISBN 0849393930, 9780849393938.
Aulton, M. E.,. Taylor, K. M. G., Aulton‘s Pharmaceutics : the design and manufacture of medicines (4th Ed) Elsevier Health Sciences, 2013. ISBN 0702042900, 9780702042904.
Ansel, H.C., Popovich, N.G., & Allen, L.V., Pharmaceutical dosage forms and drug delivery systems. Ninth edition. Publisher: Williams and Wilkins. ISBN 0683305727, 9780683305722.
Walsh, G., Pharmaceutical Biotechnology: Concepts and Applications. John Wiley & Sons, 2007. ISBN 0470012447, 9780470012444.
Baura, G., Medical Device Technologies: A system based overview using engineering standard. Academic Press. 2011. ISBN 0080961126, 9780080961125.
Other Resources
None
Additional Information
None