This course is designed to facilitate the development of knowledge and practical skills in the assessment of special risks associated with the manufacture of sterile pharmaceuticals and to develop and evaluate strategies and plans that will ensure acceptable sterility assurance levels.
The course is relevant to cleanroom and aseptic managers and supervisors as well as other staff with Good Aseptic Practices (GAP) responsibilities.
On completion of this course you should be able to:
- Assess the regulatory requirements for aseptic manufacturing processes in order to provide recommendations for their application to ensure compliance.
- Evaluate the risks associated with aseptic processing and terminal sterilisation to establish ongoing monitoring and reporting systems that can be used as the basis for changes, updates and continuous improvement.
- Critically evaluate strategies for bioburden control.
- Design sterilisation validation protocols.
- Utilise mathematical equations to evaluate, interpret and establish sterilisation parameters.
- Perform simple tasks in an aseptic manner.
- Demonstrate skills in writing reports.
- Research, assess and evaluate information.
- Evaluate data and identify facts.
This course consists of 6 modules or topics.
1 Sterility Assurance and Sterilisation This module discusses the limitations of sterility testing, the concept of sterility assurance and theory of sterilisation. On completion of this module, you should be able to:
- Differentiate between terminal sterilisation and aseptic processing.
- Define sterility assurance.
- State the limitations of the sterility test.
- List the factors that affect Sterility Assurance Levels (SAL).
- List the different sterilisation methods and provide examples of when each would be used.
- Define the terms used to measure the effectiveness of sterilisation cycles.
2 cGMP Principles of Sterile Manufacturing This module introduces you to the requirements of the cGMP Annex 1 (Manufacture of Sterile Medicinal Products). On completion of this module, you should be able to:
- State the importance of bioburden control to sterile products.
- State the cGMP focus for the manufacture of sterile products.
- Find and interpret information in the PIC/S cGMP Annex 1 for Sterile Products.
- Develop risk-based strategies for controlling bioburden.
3 Operating and Managing a Cleanroom This module discusses the work practices needed to maintain sterility of aseptically manufactured products. On completion of this module, you should be able to:
- Describe the basis for cleanroom classification.
- Compare and contrast the ISO classification system with the EU GMP classification system.
- List the tests used to qualify cleanrooms.
- List the routine checks to ensure ongoing control of cleanrooms.
- Choose the correct cleanroom garments, textile and style according to GMP requirements.
- Evaluate and qualify cleanroom operators
4 Validation of Heat Sterilisation Processes This module covers the requirements for sterilisation and depyrogenation of equipment and finished products. On completion of this module, you should be able to:
- List the essential elements of a sterilisation validation.
- List key pre-qualification activities.
- Differentiate between two sterilisation approaches (Overkill and Bioburden) and give examples of where and how each would be used.
- List the IQ, OQ and PQ requirements for heat sterilisation processes.
4a Use of Filters in Sterile Manufacturing On completion of this module, you should be able to:
- State the various filters used in sterile manufacturing.
- List validation requirements for filters.
5 Aseptic Processing This module provides an introduction to the concept of sterility assurance and its importance to aseptic processing. On completion of this module, you should be able to:
- Interpret the requirements of the FDA and EU guides to aseptic processing.
- Define the importance of media fills/process simulations to sterility assurance.
- List the validation requirements and acceptance criteria for aseptic media fills
6 Aseptic Gowning This module defines the requirements for cleanroom garments and addresses gowning techniques for aseptic manufacturing. On completion of this module, you should be able to:
- Explain requirements for selection of cleanroom garments.
- Describe the need for correct gowning technique.
- Detect defective gowning practices.
- Demonstrate correct gowning techniques for entering a sterile suite.
Optional – Blow Fill Seal (BFS) Technology On completion of this module, you should be able to:
- Define Blow/Fill/Seal Technology.
- State the advantages of Blow/Fill/Seal technology.
- Describe the Blow/Fill/Seal process.
- List the Qualification Requirements for Blow/Fill/Seal Units
Format and Course Length:
The 3-day course involves a lively mix of case studies / workshops and intensive tutorial sessions. The delivery method is collaborative with a small group and facilitator, which has been shown to enhance learning and critical thinking skills of participants. You will receive copies of all presentation slides and a Certificate.
Scheduled sessions run from 9am to 5pm unless otherwise specified.
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