University of Technology Sydney

96062 Good Aseptic Practices and Sterile Products

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 subject gives students an advanced understanding of good aseptic practices and is relevant to cleanroom and aseptic managers and supervisors. The subject teaches participants to identify risk situations that may impact sterility assurance. The subject is case-study oriented where students investigate industry situations.

Subject learning objectives (SLOs)

064. Apply Good Aseptic Practices in the manufacture of biologics and vaccines
065. Assess the impact of evolving processes and technologies on sterilisation and aseptic processes
066. Develop risk-based strategies for controlling bioburden and establishing ongoing monitoring systems
067. Evaluate and qualify cleanroom and cleanroom operations to identify potential gaps in the manufacture of sterile pharmaceutical products
068. Evaluate the regulatory requirements for aseptic manufacturing processes to provide recommendations and ensure compliance in the manufacture of sterile pharmaceutical products
069. Apply the principles and practices of sterilization processes and sterility assurance to assure the production of sterile pharmaceutical products
070. Implement appropriate validations and process control plans in manufacture and distribution to ensure sterility levels

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

Good aseptic practice is essential for minimising the risk of contamination in the production of sterile products. It adopts principles of GMP, and further develops the concepts of sterility assurance.

Good aseptic practice is fundamental to the knowledge of industrial manufacturing processes. This is important for a solid understanding of producing of sterile medicinal products, biotechnology products as well as future research and development directions. This subject provides students the opportunity to investigate the work practices associated with equipment sterilisation and depyrogenation, developing monitoring systems and aseptic processing.

Thus in 96062 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.

OPELA (online language screening task)

An aim of this subject is to help you develop academic and professional language and communication skills in order to succeed at university and in the workplace. To determine your current academic language proficiency, if you have never completed the OPELA, or this is your first session at UTS, then you are required to complete an online language screening task, OPELA (information available at https://www.uts.edu.au/research-and-teaching/learning-and-teaching/enhancing/language-and-learning/about-opela-students). If you receive a Basic grade for OPELA, you must attend follow up language development activities in order to pass the subject. These activities are outlined below:

On campus students: You must attend additional Language Development Tutorials (each week from week 3/4 to week 12). These tutorials are designed to support you to develop your language and communication skills. Students who do not complete the OPELA and/or do not attend 80% of the Language Development Tutorials will receive a Fail X grade.

Online students: You must complete additional language development activities during the teaching session. The activities will be made available to you online during the teaching session. These activities are designed to support you to develop your language and communication skills. Students who do not complete the OPELA and/or do not complete 80% of the language activities will receive a Fail X grade.

Content (topics)

Within the broad context of sterilisation and aseptic processing, you will initially learn about the development of sterilisation and principles of regulatory control including requirements, guidance and key terms for sterilisation before you learn about the documentation and the application of quality risk management as applied to aseptic processes and sterile products. With this foundational learning, you will then look more deeply into controls of environment, cleanrooms, equipment qualification, process validation, as well as monitoring of cleanrooms and personnel.

Assessment

Assessment task 1: On-going Graded Assessment

Intent:

This assessment task provides students with the opportunity to test their understanding of the course content through online discussions and receive ongoing formative feedback from their peers and teacher.

Objective(s):

This task is aligned with the following subject learning objectives:

064, 065, 066, 067, 068, 069 and 070

This task is aligned with the following course learning outcomes:

02.01, 02.04, 02.06, 02.08 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: Sterilisation Processes - Case Study Based on a Scenario in the Pharmaceutical Industry

Intent:

This assignment is designed for you to demonstrate your understanding of the concept and risks in the sterilisation of pharmaceutical products. You will apply your knowledge to measure effectiveness of sterilisation and ensure that your processes are in compliance with regulations.

Objective(s):

This task is aligned with the following subject learning objectives:

066, 068 and 069

This task is aligned with the following course learning outcomes:

02.01, 02.03, 02.04, 02.06, 02.08 and 03.11

Type: Report
Groupwork: Individual
Weight: 20%
Length:

Approximately 1500 words, excluding references

Criteria:

Provided via Canvas

Assessment task 3: Advisory report

Intent:

This assignment is designed to evaluate your understanding and application of Good Aseptic Practices and the implications for sterile product manufacturing. You will demonstrate your knowledge gained by detailing controls over environment, equipment and processes to maintain sterilisation and sterility assurance.

Objective(s):

This task is aligned with the following subject learning objectives:

064, 067, 068 and 069

This task is aligned with the following course learning outcomes:

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

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

1500 words +/- 10% (excluding references)

Criteria:

Provided via Canvas

Assessment task 4: Final Exam

Intent:

This final exam will evaluate your overall understanding of aseptic processes and sterilisation. You will provide explanations for the controls of necessary parameters to ensure achievement of sterility assurance. You will further explain the requirements and processes to validate aseptic processes, sterilisation methods and cleanroom environment.

Objective(s):

This task is aligned with the following subject learning objectives:

064, 065, 067 and 070

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: Examination
Groupwork: Individual
Weight: 35%
Length:

1 hour and 40 mins; including 10 minutes of reading time

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 assessment tasks.

OPELA

It is a requirement of this subject that all students who are in their first session at UTS or have never completed OPELA, must complete OPELA. Students who received a Basic grade in the OPELA are required to attend 80% of the Language Development Tutorials, or, for online students, complete 80% of compulsory language activities in order to pass the subject. Students who do not complete the OPELA and/or do not complete 80% of the Language Development Tutorials or compulsory language activities will receive a Fail X grade.

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
Other relevant references as identified throughout course notes and lectures.