BIO06014 2011 Sterile Fill Finish for Biologics.

General Details

Full Title
Sterile Fill Finish for Biologics.
Transcript Title
Sterile Fill Finish.
Code
BIO06014
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
ASCI - Applied Sciences
Level
06 - NFQ Level 6
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2011 - Full Academic Year 2011-12
End Term
2019 - Full Academic Year 2019-20
Author(s)
Kieran Tobin
Programme Membership
SG_SGOOD_C06 201600 Higher Certificate in Science in Good Manuf Practive & Technol
Description

This module aims to provide 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.    

Learning Outcomes

On completion of this module the learner will/should be able to;

1.

Demonstrate an understanding of techniques and skills relating to aseptic processing.

2.

Describe the fundamental aspects of sterile filling operations for modern biopharmaceuticals.

3.

Outline the main equipment involved in sterile fill finish operations and their modes of operation.

4.

Describe proper gowning principles and procedures for aseptic processing.

5.

Explain the use of media fill protocols for determining the sterility of a typical filling process. 

6.

Interpret regulatory requirements for manufacturing sterile products produced by aseptic processing.

Module Assessment Strategies

A combination of continuous assessment techniques and a final end-of-term exam.

Indicative Syllabus

The following is a summary indication of the main topics included in this module:

  • Definition and scope of aseptic processing.
  • The main equipment involved in sterile fill finish and their modes of operation.
  • Aseptic process simulations - media fills.
  • Gowning and personnel qualification and good aseptic technique.
  • Filtration and liquid filter integrity testing
  • Sterility testing and final product testing.
  • Use of isolator and barrier technology.
  • Environmental data trending and excursion analysis.

 

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
50 %
End of Semester / Year Formal Exam
50 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Continuous Assessment Short-form exams and assignments. Continuous Assessment UNKNOWN 50 % OnGoing 1,2,3,4,5,6
             
             

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Final Exam Final Exam UNKNOWN 50 % End of Term 1,2,3,4,5,6
             
             

Part Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Lecture Distance Learning Suite Online lecture. 1 Weekly 1.00
Directed Learning Not Specified Directed self-study. 4 Weekly 4.00
Total Part Time Average Weekly Learner Contact Time 5.00 Hours

Module Resources

Non ISBN Literary Resources

Pharmaceutical Biotechnology: An Introduction for Pharmacists and Pharmaceutical Scientists, 2nd Edition. J. Daan and R. Sindelar. Publisher: Taylor and Francis. ISBN: 0415285003.

Other Resources

None

Additional Information

None