University of Technology Sydney

96069 Contamination Control

Warning: The information on this page is indicative. The subject outline for a particular session, location and mode of offering is the authoritative source of all information about the subject for that offering. Required texts, recommended texts and references in particular are likely to change. Students will be provided with a subject outline once they enrol in the subject.

Subject handbook information prior to 2022 is available in the Archives.

UTS: Health (GEM)
Credit points: 6 cp
Result type: Grade and marks

There are course requisites for this subject. See access conditions.

Description

This is a foundation subject in the Master of Good Manufacturing Practice (GMP). This subject explores the principles and requirements for contamination control. It identifies the different types of contamination and potential sources of contamination, introduces risk assessment methodologies that can be used to analyse the major risks to products, and looks at how to develop strategies for contamination control. The contribution of systematic competency-based training is also explored.

Subject learning objectives (SLOs)

087. Analyse risk of product contamination using contamination risk evaluation techniques
088. Design protocols for monitoring water quality in pharmaceutical manufacturing
089. Evaluate a given set of contamination management systems, procedures and practices
090. Evaluate the regulatory requirements, standards and guidelines relating to contamination control in pharmaceutical manufacturing
091. Explain the principles of contamination control in pharmaceutical manufacturing
092. For a given project interpret data to design an environmental monitoring program
093. Implement the most appropriate risk evaluation technique for a given set of contamination management systems, procedures and practices through the case studies
094. Using environmental monitoring data from a given project, recommend required control measures

Course intended learning outcomes (CILOs)

The learning outcomes for this subject are as follows:

  • Reflect on the knowledge, skills and attributes required for the evaluation and integration of emerging evidence into practice, promoting the growth of personal and professional learning, and the education of others. (01.09)
  • Demonstrate accurate and comprehensive knowledge of risk management practices and models, and implement and evaluate them in a range of contexts. (02.01)
  • Design, implement and evaluate control systems for pharmaceuticals manufacturing. (02.03)
  • Demonstrate ethically and legally accountable approaches to pharmaceuticals manufacturing and control. (02.04)
  • Produce accurate technical documentation, and communicate effectively and accurately with clients and stakeholders in written or spoken language appropriate to their needs. (02.06)
  • Contribute as leader and collaborator in the assurance of Good Manufacturing Practice. (02.08)
  • Collaborate effectively with other professions to ensure Good Manufacturing Practice. (02.10)
  • Demonstrate knowledge of Good Manufacturing Practice in local, national and global contexts. (03.11)

Contribution to the development of graduate attributes

Here students become familiar with the skills and knowledge necessary to understand the principles and requirements for contamination control.

Thus in 96069 students progress towards achievement of the course's Lifelong Learning and Professional Capacity graduate attributes.

Lifelong Learning:

Graduates of the Master of GMP are lifelong learners, committed to and capable of reflection and inquiry in their quest for personal development and excellence in professional practice.

Professional Capacity:

Graduates of the Master of GMP are industry-focused, ethical practitioners with the understanding and proficiency to be leaders in their profession, capable of effectively analysing and implementing solutions in a global context under international regulatory guidelines.

Global Citizenship:

Graduates of the Master of Good Manufacturing Practice contribute to society, resolving to undertake those actions and responsibilities that will enhance their role in local, national and global communities.

Teaching and learning strategies

On campus (standard) mode: This subject will be delivered on the City campus and requires attendance for three hours of face-to-face contact per week, as well as approximately 1-3 hours of personal study pre-work before each class. However, should restrictions related to COVID-19 require it, classes for this subject will be conducted online. The format and content of online classes (should they be required) will be equivalent to face to face on-campus classes and the same attendance requirements apply.

Online (distance) mode: This subject is delivered online via Canvas. Students are required to contribute to weekly discussions as well as participate in occasional online meetings via zoom when required. Students should dedicate approximately 3-6 hours of time to this subject per week.

Students will learn in this Subject through online content comprising videos, set reading, directed research, activities online discussions and self-check quizzes. This independent learning will be supported by group learning experiences, in which ideas and concepts can be tested and refined

Strategy 1: Student directed learning: Students read articles and use online resources, such as online course material, videos, directed research, activities, self-check quizzes and case studies, provided via Canvas. This learning prepares students for their participation in activities that may include facilitated discussion of fundamental concepts drawn from course materials and solutions to industry case studies, assessable quizzes or activities as well as collaborative and interactive learning experiences.

Strategy 2: Collaborative and interactive learning experiences: Provide the students with the opportunity to engage with Peers and Academics to discuss and clarify concepts for a deeper understanding of online course materials.

On campus students - engage in a weekly 3 hour workshop. Each workshop aims to apply online course materials to real life pharmaceutical industry scenarios through discussions and problem solving in collaboration with fellow students.

Online students – engage in weekly discussion forums. Each online discussion aims to apply course material in real life pharmaceutical industry scenarios and collaboration with fellow students is required by posting and responding to other students posts in the discussion forum. Students participate in the online discussions by writing their comments in the Canvas platform in their own time and also read and respond to posts from peers. Each discussion has an end time designated by which students must have contributed.

Strategy 3: Early and consistent feedback: Early feedback is provided prior to the census date.

On campus students – receive feedback in workshops or via the Canvas platform for activities. Feedback regarding the quizzes is provided following each quiz, via provision of answers and/or in-class review. The collaborative learning approach utilised in class will enable ongoing feedback to be provided in class, as areas of learning need are identified through class discussions.

Online students – receive feedback during ‘open office’ hours and discussion forums. Feedback regarding the self-check quizzes is provided via Canvas immediately upon submission of each quiz. The collaborative learning approach will enable ongoing feedback to be provided to students, via teacher responses to posts, as areas of learning need are identified through online discussions.

Strategy 4: Group work: Students work together during collaborative and interactive experiences. Students will need to develop negotiation and teamwork skills, demonstrating the ability to respond respectfully and constructively to their peers, fostering communication, constructive criticism and respect for diverse ways of working.

Strategy 5: Students are encouraged to critically reflect on their learning throughout the subject to identify areas where they may improve their performance and develop lifelong learning skills.

Content (topics)

Within the broad context of contamination control, you will initially learn about the identification of contamination hazards and the implementation of procedures for control on risk based basis. You will learn to assess risks presented in pharmaceutical manufacturing scenarios and select the most effective contamination control techniques. Students work on real life cases to develop skills and application knowledge for contamination control.

Assessment

Assessment task 1: On-going Graded Assessment

Intent:

Throughout the semester you will have the opportunity to check your understanding of the course content via graded assessments through the Canvas platform.

Objective(s):

This task is aligned with the following subject learning objectives:

087, 088, 089, 090, 091 and 093

This task is aligned with the following course learning outcomes:

01.09, 02.01, 02.03, 02.04 and 03.11

Groupwork: Individual
Weight: 15%
Criteria:

Tasks are marked by the lecturer according to the specific requirements of each task. The tasks are designed to allow assessment of the student’s ability to apply and evaluate the principles learned.

Assessment task 2: Contamination Control in Pharmaceutical Manufacturing

Intent:

This assignment is designed to challenge you to present a practical approach to control contamination in a pharmaceutical manufacturing environment. In addition, you will present your proposed activities to ensure continued compliance of your contamination control program.

Objective(s):

This task is aligned with the following subject learning objectives:

089 and 091

This task is aligned with the following course learning outcomes:

01.09, 02.01, 02.03, 02.04, 02.06, 02.08 and 03.11

Type: Report
Groupwork: Individual
Weight: 25%
Length:

Approximately 1500 words, excluding references

Criteria:

Provided via Canvas

Assessment task 3: Advisory Report on Contamination Control

Intent:

This assignment is designed to position you in a real-life situation where there is a contamination problem in your company. This matter has been cited by the FDA. You will show your knowledge gained by proposing realistic actions to respond to the FDA citation and convince FDA that further contamination problem would be controlled.

Objective(s):

This task is aligned with the following subject learning objectives:

087, 091 and 092

This task is aligned with the following course learning outcomes:

01.09, 02.01, 02.03, 02.04, 02.06, 02.08 and 03.11

Type: Case study
Groupwork: Individual
Weight: 30%
Length:

Minimum of 1500 words, no limit

Criteria:

Provided via Canvas

Assessment task 4: Control of Microbiological Contamination

Intent:

This final assessment is for you to show your overall understanding of the control of physical, chemical and microbiological contamination. You will demonstrate these controls through the design and implementation of HVAC systems. In addition, you will show the need for continuous environmental monitoring programs and the importance of a validated pharmaceutical grade water system.

Objective(s):

This task is aligned with the following subject learning objectives:

087, 088, 089, 090, 091, 092, 093 and 094

This task is aligned with the following course learning outcomes:

01.09, 02.01, 02.03, 02.04, 02.06, 02.08, 02.10 and 03.11

Type: Report
Groupwork: Individual
Weight: 30%
Length:

Minimum of 1500 words, no limit

Criteria:

Provided via Canvas

Minimum requirements

In order to pass this Subject, a minimum grade of 50% must be achieved.

Students are required to attend a minimum of 85% of classes and submit all assessments.

Required texts

Coursework Assessments Policy

Coursework Assessments Procedures

Graduate School of Health Policy, Guidelines and Procedures (login required)

Additional required readings will be provided via Canvas

Recommended texts

The PIC/s Code of GMP, Annex 1