Fundamentals of Biology & Contamination Control for Clean Rooms Technology

“Two 10-credit Level 6 Waterford Institute of Technology modules aimed at employees seeking to upskill their knowledge of Microbiology and ideally suited to those working in Pharma based environments or seeking a move into such a career.

Module 1: Fundamentals of Biology – 10 Credits

Module 2: Contamination Control for Clean Rooms – 10 Credits

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Module 1: Fundamentals of Biology – Descriptor

Description of Module / Aims

This module will introduce you to biology, biochemistry and microbiology, focusing on biological terminology and microbiological techniques. It will also introduce the you to the concepts of environmental biology and pollution, and their impact on industry as well as the environment.

Indicative Content

  • The cell: cell structure; prokaryotic versus eukaryotic and animal versus plant, cell organelles and their roles, fluid mosaic model of biological membranes etc.
  • Biological molecules: protein, carbohydrate and lipid structure and biological function.
  • Enzymology: definition, enzyme properties, enzyme classes and enzyme specificity in biological organisms; factors affecting enzyme activity; applications of enzymes.
  • Immunology: antibodies, antigens and the immune response; vaccination; applications of antibody antigen interactions.
  • Microbiology: introduction to bacteria, fungi and viruses; positive and negative roles of microorganisms; sources of biological contamination, hygiene control; microbiological techniques; biological control.
  • Environmental biology: environmental biocycles; carbon, nitrogen biocycles; water, soil and air pollution control and monitoring.

Learning Outcomes

On successful completion of this module, a student will be able to:

  1. Use standard laboratory techniques to isolate, purify and stain bacteria and fungi for microscopic examination.
  2. Use standard laboratory techniques and rapid detection methods to assess biological contamination, determine hygiene levels and identify a number of microorganisms.
  3. Describe the structure of a number of microorganisms.
  4. Describe the concepts of cells, biological molecules, microorganisms and biological contamination.
  5. Identify procedures to prevent biological contamination of product and environment.
  6. Discuss environmental biocycles and the importance of environmental pollution control.
  7. Record results of laboratory work using a combination of formal written laboratory reports and worksheets.

Learning and Teaching Methods

  • Lectures.
  • Laboratory-based practical classes.
  • In-class discussions
  • Self-directed study

Assessment Methods

  • Practical.
  • Continuous Assessment
  • Final Written Examination

Dates:

Fundamentals of Biology: 24 hours lecture; 12 hours of lab.  (10 credits) running on Wednesdays 17.15 – 19.15 in the coming semester and the labs are held on 2 Saturdays (6 hours each)

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MODULE 2 – CONTAMINATION CONTROL CLEANROOM MANAGEMENT (A09761) (10 CREDITS) – Descriptor

Description of Module / Aims

This module covers aspects of Cleamoom design, installation and maintenance. Students will be able to work in a Grade A/B Cleanroom and learn the importance of cleaning, routine operation and monitoring to maintain the integrity of the area to produce Parenteral products.

Indicative Content

      • Cleanroom design and classification; fundamentals of air filtration: principles of HEPA filtration and HVAC systems.
      • Disinfectant efficacy testing, testing the effectiveness of cleaning agents; cleaning validation.
      • Media fill trials using various combinations of equipment / staff / shift patterns; environmental monitoring programmes; particulate, microbial, in the ‘at rest ‘ and ‘in operation’ states.
      • Barrier/isolator technology as used in the control of contamination in pharmaceutical manufacturing facilities.
      • Clothing and housekeeping practices for the clean room staff and maintenance contractors; critical control of cleanroom entrance practices.
      • Principles of steam sterilisation and vaporised hydrogen peroxide.
      • Cleaning, decontamination and segregation of working areas within cleanrooms; introduction to specialised methods of cleaning and decontaminating cleanrooms.

Learning Outcomes

On successful completion of this module, a student will be able to:

      1. Apply the principles of A/B Cleanroom design and associated barrier technology for sterile manufacturing.
      2. Complete in-media simulation trials to qualify the cleanroom facility, personnel and operations.
      3. Explain how to decontaminate and monitor the A/B Cleanroom facility.
      4. Describe a cleaning validation strategy.

Learning and Teaching Methods

      • Lectures.
      • Review of literature on aseptic processing.

Assessment Methods

    • In-Class Assessment
    • Continuous Assessment
    • Final Written Examination

Dates:

Contamination Control and Cleanroom Management: 24 hours of lecture Tuesday and Thursday at 16.15 – 18:15

Fees: This program is €680pp Modules 1 and 2. This program is funded under the Skillnet Ireland Future Skills Initiative.

Module 3 – Industrial Microbiology – Going forward we would like to explore the development of a 10 credit ‘Industrial Microbiology’ module aimed at up-skilling candidates further in the area of Microbiology with the hope that employees would be able to migrate within their present employment to this developing area amongst the South East industries. Further interest in the development of this module will be explored on rollout of Modules 1 and 2.

N.B. Dates listed below may be subject to change.

  • Contamination Control for Clean Room Technology
    29th September 2020 - 16th December 2020
    4:15 pm - 6:15 pm
  • Fundamentals of Biology
    30th September 2020 - 17th December 2020
    5:15 pm - 7:15 pm

Registration Options

Details Price Qty
Fundamentals of Biology & Contamination Control for Clean Roomsshow details + €680.00 (EUR)  

Venue:  

Venue Phone: 353 (0)51 302000

Venue Website:

Address:
Waterford Institute of Technology, Cork Road, Waterford, Munster, Ireland

Description:
Waterford Institute of Technology is a state funded third-level educational freely available large scale institution situated in the city of Waterford, Ireland.