PHRM07017 2020 Pharmaceutical Processing and Medical Device Manufacture

General Details

Full Title
Pharmaceutical Processing and Medical Device Manufacture
Transcript Title
Pharmaceutical Processing and
Code
PHRM07017
Attendance
N/A %
Subject Area
PHRM - Pharmaceutical Science
Department
LIFE - Life Sciences
Level
07 - NFQ Level 7
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2020 - Full Academic Year 2020-21
End Term
9999 - The End of Time
Author(s)
Declan Shelly, Yvonne Lang, Tom Patton
Programme Membership
SG_SPHAD_B07 201900 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 describe the methods to ensure the sterility of pharmaceutical preparation to the point of primary container closure selection and processing.

5.

Contrast solid dosage form production techniques, from dry powder mixing to finished dosage formation and the packaging methods and requirements.

6.

To have an appreciation of the medical device industry and the main classification of product types.

Teaching and Learning Strategies

This module will be delivered part time (on-line). This will include lectures, augmented by independent learning and directed learning. This approach is expected to address student learning needs. Moodle will be used as a repository of educational resources and as a potential means of assessment (e.g. quizzes, uploading assignments and journals).

Module Assessment Strategies

This module will be assessed using a combination of end of semester final exam (60%), continuous assessment and course work (40%).

The continuous assessment and course work will involve Short Answer Questions/Multiple Choice Questions/Assignment Work where students will be required to (i) demonstrate an understanding of core module concepts, and (ii) presentations on topics which demonstrates the student's ability to critically evaluate an aspect of the subject area.

Repeat Assessments

Repeat Continuous Assessment and/or Final Exam.

Module Dependencies

Prerequisites
None
Co-requisites
None
Incompatibles
None

Indicative Syllabus

To detail the mainstream systems and equipment used for generation of EP and USP grade water for Pharm/Biopharma production and manufacture.

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.

To demonstrate a knowledge of the various information technology applications operating in the pharmaceutical industry.

Computerised system control. - Scada, PLCs, EBMR, ERP.

Batch Records - documentation, labelling (RFID), dispensing, LAF.

To distinguish how non sterile Pharma/cosmetic products are manufactured, processed and the packaging options/requirements suited to each type of formulation.

Non sterile - Ingredients, Creams, gels, liquids (suspensions, emulsions), mixing, milling, filling (tubes plastic, alu, bottles glass, plastic, sachet), packaging.

To appraise the cleaning requirements of process equipment and methods employed by industry to combat this requirement.

Contrast solid dosage form production techniques, from dry powder mixing to finished dosage formation and the packaging methods and requirements.

Solid dosage form - Tableting – Ingredients, mixing, granulation, compression, coating, blister packs.

To describe the methods to ensure the sterility of pharmaceutical preparation to the point of primary container closure selection and processing.

Sterile Liquids , Parenterals - Formulation, Sterile manufacture, filtration, filling, packaging BFS, Terminal sterilization, ETO.

Biologics - Fermentation, scale up, harvesting, disruption, filtration, filling, lyophilization, packaging Vials.

Demonstrate a knowledge and understanding of the medical device industry and the main product types currently being manufactured.

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 on processing technology Continuous Assessment Group Project 10 % OnGoing 3,4,5
2 Assignment Short Answer Questions/Multiple Choice Questions/Assignment Work Continuous Assessment Assignment 30 % OnGoing 1,2,3,4,5,6
             

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Final Exam End of term exam Final Exam Closed Book Exam 60 % End of Term 1,2,3,4,5,6
             
             

Online Learning Mode Workload


Type Location Description Hours Frequency Avg Workload
Lecture Online Lecture 2 Weekly 2.00
Total Online Learning Average Weekly Learner Contact Time 2.00 Hours

Required & Recommended Book List

Recommended Reading
2013-07-01 Encyclopedia of Pharmaceutical Science and Technology, Fourth Edition, Six Volume Set (Print) CRC Press
ISBN 1841848190 ISBN-13 9781841848198

Pharmaceutical science deals with the whole spectrum of drug development from start to finish. There are many different facets to the pharmaceutical industry, from initial research to the finished product, including the equipment used, trials performed, and regulations that must be followed. Presenting an overview of all of these different aspects, the Encyclopedia of Pharmaceutical Science and Technology, Fourth Edition is a must-have reference guide for all laboratories and libraries in the pharmaceutical field. Bringing together leaders from every specialty related to pharmaceutical science and technology, this is the single-source reference at the forefront of pharmaceutical R&D. The strength of this work is not only its breadth but also the caliber of contributing writers, all experts in their field, writing on all aspects of pharmaceutical science and technology. The fourth edition offers 29 new chapters ranging from biomarkers, computational chemistry, and contamination control to high-throughput screening, orally disintegrating tablets, and quality by design. The encyclopedia details best practices of equipment used, methods for manufacturing, options for packaging, and routes for drug delivery. The volumes also provide a thorough understanding of the choices behind each method. In addition, the regulations, safety aspects, patent guidance, and methods of analysis are presented. Key Areas Covered: Analytics Biomarkers Dosage forms Drug delivery Formulation Informatics Manufacturing Packaging Processing Regulatory affairs Systems validation This is an authoritative reference source for those practicing in any area of pharmaceutical science and technology, enabling the pharmaceutical specialist and novice alike to keep abreast of developments in this constantly evolving and highly competitive field. * Online version coming soon. Contact us to inquire about subscription options and print/online combination packages. US: (Tel) 1.888.318.2367 / (E-mail) e-reference@taylorandfrancis.com International: (Tel) +44 (0) 20 7017 6062 / (E-mail) online.sales@tandf.co.uk

Recommended Reading
2013 Aulton's Pharmaceutics Elsevier Health Sciences
ISBN 9780702042904 ISBN-13 0702042900

Pharmaceutics is one of the most diverse subject areas in all of pharmaceutical science. In brief, it is concerned with the scientific and technological aspects of the design and manufacture of dosage forms or medicines. An understanding of pharmaceutics is therefore vital for all pharmacists and those pharmaceutical scientists who are involved with converting a drug or a potential drug into a medicine that can be delivered safely, effectively and conveniently to the patient. Now in its fourth edition, this best-selling textbook in pharmaceutics has been brought completely up to date to reflect the rapid advances in delivery methodologies by eye and injection, advances in drug formulations and delivery methods for special groups (such as children and the elderly), nanomedicine, and pharmacognosy. At the same time the editors have striven to maintain the accessibility of the text for students of pharmacy, preserving the balance between being a suitably pitched introductory text and a clear reflection of the state of the art. provides a logical, comprehensive account of drug design and manufacture includes the science of formulation and drug delivery designed and written for newcomers to the design of dosage forms New to this edition New editor: Kevin Taylor, Professor of Clinical Pharmaceutics, School of Pharmacy, University of London. Twenty-two new contributors. Six new chapters covering parenteral and ocular delivery; design and administration of medicines for the children and elderly; the latest in plant medicines; nanotechnology and nanomedicines, and the delivery of biopharmaceuticals. Thoroughly revised and updated throughout.

Recommended Reading
2017-11 Ansel's Pharmaceutical Dosage Forms and Drug Delivery Systems LWW
ISBN 1496347285 ISBN-13 9781496347282

Succeed in your course with Ansel's Pharmaceutical Dosage Forms and Drug Delivery Systems, the most comprehensive source on this subject available today!

Recommended Reading
2007-08-13 Pharmaceutical Biotechnology John Wiley & Sons
ISBN 9780470012444 ISBN-13 0470012447

Offers a comprehensive introduction to the principles and concepts of pharmaceutical biotechnology.

Recommended Reading
1998-02-11 Pharmaceutical Production Facilities Taylor & Francis
ISBN 9780748404384 ISBN-13 0748404384

Pharmaceutical Production Facilities: Design and Applications considers the concepts and constraints that have to be considered in the design of small, medium and large scale production plants. The layout, along with the flow of materials and personnel through facilities are considered with reference to ensuring compliance with current good manufacturing practice. The book explains how clean rooms have developed, and how recent regulations affect their design. The latest concepts for reducing contamination levels from the operator and the product are discussed. It assess current changes in standards and quality control and makes suggestions for the "ideal production environment" to enable standards to be validated to current standards.

Recommended Reading
2011-09-28 Medical Device Technologies Academic Press
ISBN 9780080961125 ISBN-13 0080961126

Medical Device Technologies introduces undergraduate engineering students to commonly manufactured medical devices. It is the first textbook that discusses both electrical and mechanical medical devices. The first 20 chapters are medical device technology chapters; the remaining eight chapters focus on medical device laboratory experiments. Each medical device chapter begins with an exposition of appropriate physiology, mathematical modeling or biocompatibility issues, and clinical need. A device system description and system diagram provide details on technology function and administration of diagnosis and/or therapy. The systems approach lets students quickly identify the relationships between devices. Device key features are based on five applicable consensus standard requirements from organizations such as ISO and the Association for the Advancement of Medical Instrumentation (AAMI). The medical devices discussed are Nobel Prize or Lasker Clinical Prize winners, vital signs devices, and devices in high industry growth areas Three significant Food and Drug Administration (FDA) recall case studies which have impacted FDA medical device regulation are included in appropriate device chapters Exercises at the end of each chapter include traditional homework problems, analysis exercises, and four questions from assigned primary literature Eight laboratory experiments are detailed that provide hands-on reinforcement of device concepts

Module Resources

Non ISBN Literary Resources

N/A

Journal Resources

None.

URL Resources

https://ec.europa.eu/health/documents/eudralex/vol-4_en

https://www.ich.org/home.html

http://www.pharmtech.com/pharmtech-europe-0

https://ispe.org/initiatives/europe

Other Resources

None

Additional Information

None