BIO06017 2011 Sterile Operations Practical Laboratory.

General Details

Full Title
Sterile Operations Practical Laboratory.
Transcript Title
Sterile Ops. Lab. Practicals
Code
BIO06017
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
ASCI - Applied Sciences
Level
06 - NFQ Level 6
Credit
10 - 10 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_SASEP_E06 201100 Certificate in Science in Aseptic Processing. SG_SGOOD_C06 201600 Higher Certificate in Science in Good Manuf Practive & Technol
Description

This module aims to provide students with a practical, hands-on, knowledge and overall understanding of the key technologies and their applications in sterile operations for the pharmaceutical and biopharmaceutical industries.        

Learning Outcomes

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

1.

Demonstrate an increased proficiency in the techniques and skills associated with aseptic processing.

2.

Outline the main steps involved in setting up a sterile fill system for drug filling applications. 

3.

Incorporate proper gowning and cleanroom monitoring techniques for aseptic processing.  

4.

Demonstrate the concept of a media-fills run for a typical filling operation and its associated equipment.

5.

Perform  practical laboratory experiments for CIP and SIP operations.

6.

Perform practical laboratory experiments for sterilisation/autoclaving.

 

Module Assessment Strategies

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

Indicative Syllabus

The following is an indicative summary of the main topics included in this module:

  • Cleanroom preparation and monitoring for aseptic processing.
  • Gowning technique for appropriate clearnoom classification. 
  • Setup of the filling operation for an aseptic cycle. 
  • Demonstrate the concept of a media-fills run on the filling operation. 
  • Perform  practical experiments for Clean-in-Place (CIP) and Steam-in-Place (SIP) applications.
  • Perform practical experiments for the sterilisation/autoclaving of components for aseptic processing.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
70 %
End of Semester / Year Formal Exam
30 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Continuous Assessment Short-form exams/quizzes and lab. practical write-ups. Continuous Assessment UNKNOWN 70 % 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 30 % 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
Laboratory Practical Science Laboratory Laboratory practical experiments. 24 Once Per Semester 1.60
Directed Learning Not Specified Directed self-learning. 5 Weekly 5.00
Total Part Time Average Weekly Learner Contact Time 7.60 Hours

Module Resources

Non ISBN Literary Resources

‘Pharmaceutical Biotechnology - Concepts and Applications' by Gary Walsh.

Wiley Publications.  2007.  ISBN - 978-0-470-01244-4.

‘Basic Biotechnology' by Colin Ratledge and Bjorn Kristiansen.

Cambridge Press. 2001.  ISBN - 0-521-779170.

Other Resources

None

Additional Information

None