Module Details

Module Code: SCIE C2101
Module Title: Aseptic Techniques
Title: Aseptic Techniques
Module Level:: 6
Credits:: 5
Module Coordinator: Paula Rankin
Module Author:: Dina Brazil
Domains:  
Module Description: To give learners the fundamental knowledge, skills and competencies in aseptic techniques in accordance with cGMP in an aseptic hospital compounding context.
 
Learning Outcomes
On successful completion of this module the learner will be able to:
# Learning Outcome Description
LO1 Outline the basis of microbial contamination and infection in a clinical setting and outline how microorganisms may be monitored and controlled.
LO2 Describe the principles underpinning the safe, accurate and aseptic preparation and monitoring of parenteral and other sterile products including cytotoxics.
LO3 Competently demonstrate and validate the correct aseptic techniques, behaviours and monitoring for use in a clean environment/compounding unit including the use of validated SOPs.
Dependencies
Module Recommendations

This is prior learning (or a practical skill) that is recommended before enrolment in this module.
No recommendations listed
Co-requisite Modules
No Co-requisite modules listed
Additional Requisite Information
No Co Requisites listed
 
Indicative Content
Microbial contamination, infection and control
Basic microbiology concepts. Microbial growth. Infectious disease transmission; the compromised host, pathogens, reservoirs of infection, and vectors of transmission. Infection control. Contamination. Environmental monitoring. Chemical and physical factors controlling microbial growth. Sterilisation. and disinfection. Filter sterilisation of air and liquids. Method validation.
Principles of sterile preparation
Parenteral and sterile products and their uses. Living and non living contaminants, pyrogens. Sources of animate and inanimate contamination in the preparation or use of sterile products. Clean room design and classification. HEPA filters, unidirectional air flow cabinets, isolators.
Risk Assessment, Quality and cGMP
Identifying hazards and minimising risks to all in aseptic compounding. Quality control and Quality Assurance. Principles of cGMP for aseptic preparation manufacturing. Corrective and Preventative Action. The importance of method validation . Monitoring and checking. Documentation. worksheets and labels
Practical
Practicals will develop the key technical skills necessary to demonstrate the learning outcomes listed above in addition will enhance aspects of theory by providing hands on experience.
Health and Safety
Identifying hazards and minimising risks in the compounding unit, e.g. spills, sharps, biohazards, chemical hazards. The importance of using SOPs.
Behaviour and Gowning
Correct personal behaviour and attitudes in a clean environment including correct hand washing and gowning.
Cleaning , Disinfection and Sterilisation
Underpinning principles of and validation of hand washing, cleaning, disinfection and sterilisation disinfection. Disinfect formats. Effective use of sprays and wipes.
Monitoring and Recording
Personal , environmental, hard surface and air microbial monitoring and recording; broth tests.
Aseptic Manipulations
Tray set ups. Aseptic use of sterile equipment such as syringes, needles, vials, ampoules infusion bags, in the accurate compounding of sterile products. Working in a unidirectional air flow environment. Transfer techniques. Worksheets, labels and and records.
Safe Use of Cytotoxics
Hazards involved in the preparation of cytotoxic drugs. Closed transfer devices, safe packaging and disposal.
Module Content & Assessment
Assessment Breakdown%
Continuous Assessment50.00%
Practical50.00%

Assessments

Full Time

Continuous Assessment
Assessment Type Other % of Total Mark 20
Timing n/a Learning Outcomes 1
Non-marked No
Assessment Description
Short assignment/presentation/poster as appropriate.
Assessment Type Other % of Total Mark 20
Timing n/a Learning Outcomes 2
Non-marked No
Assessment Description
Short assignment/presentation/poster as appropriate.
Assessment Type Examination % of Total Mark 10
Timing n/a Learning Outcomes 1,2
Non-marked No
Assessment Description
MCQ and short answer questions
No Project
Practical
Assessment Type Practical/Skills Evaluation % of Total Mark 10
Timing n/a Learning Outcomes 3
Non-marked No
Assessment Description
Student created video/ poster/ assignment demonstrating reflection on practical competencies learned during the module.
Assessment Type Practical/Skills Evaluation % of Total Mark 40
Timing n/a Learning Outcomes  
Non-marked No
Assessment Description
Prepractical quizzes; demonstration of competencies, submission of reports ; short questions; reflection
No End of Module Formal Examination
Reassessment Requirement
Exam Board
It is at the discretion of the Examination Board as to what the qualifying criteria are.

SETU Carlow Campus reserves the right to alter the nature and timings of assessment

 

Module Workload

Workload: Full Time
Workload Type Workload Category Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecture Contact No Description 12 Weeks per Stage 2.00 24
Laboratory Contact No Description 12 Weeks per Stage 2.00 24
Estimated Learner Hours Non Contact No Description 15 Weeks per Stage 5.13 77
Total Weekly Contact Hours 4.00
 
Module Resources
Recommended Book Resources
  • IT Carlow Aseptic techniques Laboratory Manual.
  • Hospital Pharmacist Association of Ireland (HPAI). (2013), HPAI National Guidelines for Aseptic Compounding in Irish Hospital Pharmacy Practice (H-PIC\S), 1. HPAI, https://hpai.ie/resources/Documents/HPICS-complete.pdf.
  • John Sharp (Interpharm /CRC press). (2001), Quaity rules; a short guide to good manufacturing practice, [ISBN: 10: 1574911317].
  • HSE. HSE guidGuidelines on the safe handling and use of cytotox drugs, HSE, HSE guideline on the safe handling and use of cytotox drugs aug 2016.pdf https://www.hse.ie/eng/staff/safetywellbeing/healthsafetyand%20wellbeing/hse%20guideline%20on%20the%20safe%20handling%20and%20use%20of%20cytotox%20drugs%20%20aug%202016.pdf.
  • Michael T. Madigan... [et al.]. (2009), Brock biology of microorganisms, 12th. Pearson/Benjamin Cummings, San Francisco, CA, [ISBN: 0132324601].
Supplementary Book Resources
  • David M. Carlberg. (2005), Cleanroom Microbiology for the Non-Microbiologist, Alpha Science Int'l Ltd., p.196, [ISBN: 9780849319969].
  • EudraLex. (2008), Volume 4; Good manufacturing practice (GMP) Guidelines.
This module does not have any article/paper resources
Other Resources
Discussion Note: