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Good Aseptic Practices and Sterile Products

Unit Code:HES6413

Credit Points	Duration	Contact Hours	Campus	Prerequisite	Corequisite
12.5 Credit Points	1 Semester or Teaching Period	30 Hours	External Venue, Hawthorn	Nil, however a basic understanding of, GMP and practical work experience within the industry is assumed. Completion, or co-completion, of HES6401, HES6402and HES6403 is therefore desirable.	HES6401 International Good Manufacturing Practices and Quality Assurance HES6402 Good Manufacturing Practices for Manufacturing Operations HES6403 Validation Principles

Credit Points

Duration

Contact Hours

Campus

Prerequisite

Corequisite

12.5 Credit Points

1 Semester or Teaching Period

30 Hours

External Venue, Hawthorn

Nil, however a basic understanding of, GMP and practical work experience within the industry is assumed. Completion, or co-completion, of HES6401, HES6402and HES6403 is therefore desirable.

HES6401 International Good Manufacturing Practices and Quality Assurance

HES6402 Good Manufacturing Practices for Manufacturing Operations

HES6403 Validation Principles

Related Course/s:

An elective unit of study in the Graduate Certificate of Science (Good Manufacturing Practices), Graduate Diploma of Science (Good Manufacturing Practices), Master of Science (Good Manufacturing Practices) and Master of Science (Good Manufacturing Practices) (Honours).

Aims & Objectives:

This advanced unit of study is designed to give an advanced understanding of good aseptic practices, relevant to cleanroom and aseptic managers and supervisors. The unit of study is designed to teach participants to identify risk situations that may reduce sterility assurance. In order to do this, the unit of study is case study orientated and students are encouraged to investigate industry situations.

At the end of this unit of study students will be able to:

GMP Principles - Sterile Manufacturing

State the special cGMP requirements for the manufacture of sterile products.
Define the difference between aseptic processing and terminal sterilisation of products.
Find information in the EU cGMP Annex #1 for Sterile Products.
List the key principles of sterile manufacture to minimise risk.
State the importance of bioburden control.

Sterility Assurance and Sterilisation

State the difference between sterility assurance and the sterility test.
List factors that affect sterility assurance levels (SAL).
State conditions for successful sterilisation.
Define the importance of media fills to Sterility Assurance.

Operating in and Managing a Cleanroom

Describe the design requirements for cleanrooms.
Describe the operational requirements for cleanrooms.
List the Do's and Dont's of Cleanroom Behaviour.
List the environmental standards for Cleanrooms.
Describe various requirements for operator qualification.

Validation of Autoclaves and Depyrogenation

Understand the manufacturing controls used for aseptically filled and terminally sterilised products.
Define the terms z, D & F and be able to use them to calculate cycle parameters for Sterilisation processes.
State conditions for successful sterilisation.
List the IQ, OQ and PQ requirements for moist heat sterilisation, dry heat sterilisation and radiation sterilisation.

Aseptic Processing

State the special conditions for aseptic processing.
Bioburden and Aseptic Processing - sources and controls.
List the validation requirements for aseptic filtration.
Define the importance of media fills to sterility assurance.

Sterile Manufacture of Biotech Products

List the major process steps for biotechnology products.
Describe the difference between open and closed processing.
Describe conditions for Bioburden control.
Describe conditions for pyroburden control.

Teaching Methods:

Lectures/Tutorials, Laboratory and/or experiential off-campus learning, Case studies based on actual events that have occurred in the pharmaceutical and related industries will be used, Web Based Unit Presence (Blackboard).

Assessment:

Assignments (40%)
Test (20%)
Portfolio (10%)
Examination (30%)

Generic Skills Outcomes:

Students will be provided with feedback during the assessment for this unit of study on their progress in attaining the following generic skills:

Teamwork skills,
Analysis skills,
Problem solving skills,
Communications skills,
Ability to tackle unfamiliar problems, and the
Ability to work independently

Content:

GMP Principles -Sterile Manufacturing:
This module introduces the participants to the requirements of the EU cGMP Annex 1 (Manufacture of Sterile Medicinal Products). The module covers all critical cGMP areas such as personnel, critical equipment, water systems and 'sterile' water, cleanroom monitoring and control, bioburden controls and principles of sterility assurance.

Sterility Assurance and Sterilisation:
This module discusses the limitations of sterility testing, the concept of sterility assurance and theory of sterilisation. The purpose and requirements for media fills are also presented.

Operating in and Managing a Cleanroom:
This module discusses the work practices needed to maintain sterility of aseptically manufactured products. It provides the knowledge needed to understand why these practices are needed and stresses the importance of supervision and monitoring systems.

Validation of Autoclaves and Depyrogenation:
This module covers the requirements for sterilization and depyrogenation of equipment and finished products

Aseptic Processing:
This module provides an introduction to the concept of sterility assurance and its importance to aseptic processing. It provides an overview of the conditions for successful aseptic processing and explains the difference between sterility assurance and sterility testing:

Sterile Manufacture of Biotech Products:
This module provides important concepts for the manufacture and sterility assurance over biotechnology products:

Reading Materials:

A Course Reference Manual
Industry specific case study & workshop materials
Lecture notes (provided via Blackboard)

Textbooks:

Printed notes will be supplied