Certificate in Fill Finish Operations

Description

This module provides students with a general knowledge and understanding of the critical aspects of aseptic/sterile technique as it relates to filling operations for the biologics Industry.

This blended course of 2 mornings online theory and 2 days NIBRT onsite practicals introduces the typical fill finish operations carried out in a biopharmaceutical manufacturing facility.
This course delivers online theory covering aseptic processing, fill finish process overview including lyophilisation, barrier systems, decontamination methods, aseptic process simulations as well as QC in fill finish.

The hands-on practical days in NIBRT compliment this theory with practical sessions covering an overview of a filling line, aseptic gowning, filter integrity testing, aseptic process simulations and filling line troubleshooting scenarios.

Learning Outcomes

• Outline the basic aspects of sterile filling operations for biologics
• Describe the main equipment involved in sterile fill finish operations and their modes of operation.
• Explain proper gowning principles and procedures for aseptic processing.
• Describe the use of media fill protocols for determining the sterility of a typical filling process.

Entry Requirements

To be eligible, applicants must have completed the Mandatory Practical attendance for this module with NIBRT within the previous 12 months.

Please Note: If you wish to apply for more than one module on this programme (Downstream Processing/ Upstream Processing/ Fill Finish Operations/ Cleanroom Behaviour) please detail all modules on one application form.

Credits

5 credits

Coursework

100%