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.

NIBRT Global Qualification (NGQ) 

The NIBRT Global Qualifications (NGQs) are internationally recognised training qualifications setting a new benchmark for biopharmaceutical education and workforce development. 

Earn your NGQ by completing a micro-credential accredited by ATU – a short, flexible and accredited way to upskill and advance your biopharma career.

Step 1 – Complete a fill-finish operations practical training course at the NIBRT facility or at an affiliated NIBRT Global Partner site.
The fill-finish operations practical training module provides students with a fundamental understanding of both the theoretical and practical aspects covering an overview of a filling line, aseptic gowning, filter integrity testing, aseptic process simulations and filling line troubleshooting scenarios.

Step 2 – Register for the corresponding NGQ below for €500. To earn the qualification, you will complete a multiple-choice quiz, a 2,000-word lab report, and a 1,500-word reflective assessment. Upon successful completion, you will receive your accredited NGQ certificate (5 ECTS). NGQs are stackable, leading to a Special Purpose Award (30 ECTS).

Fee Payment: €500 fee is paid directly to NIBRT via a payment link that will be sent post registration. If you have received a funding subsidy, you will be sent a payment link for the adjusted amount owed.

For further information access: https://www.nibrt.ie/ngqs/

Credits

5 credits

Coursework

100%