Controlling Contamination within the Cleanroom

This programme is available In-House and currently delivered through virtual classroom training.

Every industry in Ireland today that has a cleanroom, needs to be absolutely sure that the personnel who work there, are fully aware and strictly adhere to the tight controls necessary to ensure contamination within this environment is very tightly controlled. Cleanroom personnel, when working in cleanrooms for long periods of time, can often become complacent in their working habits. This can be greatly improved by providing personnel with a better understanding of contamination, how it can enter a cleanroom and its impact on the process and products. This up-skilling/re-skilling of personnel with the relevant skills, awareness and knowledge will greatly help them to take ownership of their role within the cleanroom and the products they produce, with a specific focus on controlling and minimising the risk of contamination. The aim of this programme is to give delegates a better understanding and heightened awareness as to how they and the various cleanroom processes they perform, can significantly contribute to contamination levels.

Delivery Mode

  • Customised
    In-Company
    Programmes

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Course Code
LS012

What's covered?

The programme offers the participants from different backgrounds, an opportunity to work together in exploring challenges, solving problems and finding solutions to issues that are relevant to all businesses that have a cleanroom environment.

  • Overview of Cleanrooms & Contamination
  • Cleanroom Air Systems
  • Cleanroom Clothing & Gowning Practices
  • Effective Handwashing Practices
  • Cleanroom Policies & Behaviours
  • Effective Material Transfer Processes
  • Effective cleaning of surfaces and cleanroom equipment
  • Environmental & Product Monitoring of the Cleanroom
  • Assessment
  • Feedback

The training programme is very interactive, constantly encourages feedback from the participants and applies different training methods and styles to deliver the key messages e.g. discussions, group activities, demonstrations and practical exercises.

Who should participate?

Any person in the organisation/service sector who is involved in working with cleanrooms e.g. Management, Operations, Quality, Engineering, Purchasing, Warehouse, Maintenance, Cleaning, Security Staff and Construction workers.

What will I learn?

Participants achieve the following learning outcomes from the programme;

  • Understand why cleanrooms are required for manufacturing.
  • Understand what ‘contamination’ of the cleanroom means.
  • Identify & understand the different types of contamination within the cleanroom and the levels of criticality.
  • Understand what cleanroom classification is.
  • Recognise the impact and effects should contamination enter the cleanroom.
  • Appreciate how the cleanroom functions to minimise contamination.
  • Understand the need for such strict procedures regarding cleanroom policies & behaviours.
  • Identify what are and are not acceptable behaviours in the cleanroom.
  • Understand the function of cleanroom garb.
  • Perform effective hand-washing.
  • Perform cleaning of their bench surfaces & equipment effectively.
  • Transfer materials into the cleanroom effectively.
  • Understand why the cleanroom is monitored and the different types of microbial monitoring that is performed in the cleanroom and on product.

Who are the tutors?

Kevina O’Donoghue

Kevina takes great pride in the training she delivers. She understands that supporting you effectively means meeting challenges and deadlines, understanding your specific needs, communicating effectively with you and providing accurate and honest advice, with integrity and confidentiality.

Kevina is a PhD graduate from the National University of Ireland, Galway. Since graduating she has worked in the life science industry for 20 years, both nationally and internationally. Beginning in the diagnostics sector, working for Cambridge Diagnostics she then moved to the medical device sector working for Abbott Vascular, Galway. Here she worked as a Microbiologist and was closely involved in the setting up, validation and monitoring of cleanroom environments.

Kevina delivers training programmes on many different topics related to Auditing, CE Marking, Quality Standards, Cleanroom Controls and Behaviours, GMP, as well as developing bespoke training programmes to meet specific client’s needs. Kevina’s outstanding attribute is her ability to motivate learners and enable their learning through sharing her knowledge and work-based experiences, in a simple and easy to understand way thus allowing the learners to achieve their learning goals successfully.

In addition to providing expert training, Kevina routinely works as a consultant and auditor. Kevina has the expertise to deal effectively with both Cleanroom, Quality and Regulatory related issues. Kevina is knowledgeable in many different quality and regulatory standards within the medical device, pharmaceutical, laboratory, & healthcare industries, is a strong and experienced auditor consistently challenging systems for compliance in a fair and consistent manner. With the wealth of experience Kevina has accumulated to date working with many different companies, she can appreciate and identify many similar situations thus allowing her to link examples and communicate clearly and effectively to ensure understanding.

Kevina provides key support to both start up and multinational companies. She is an accomplished trainer with a Certificate in Training and Continuing Education from NUI, Maynooth and has also successfully completed QMS Auditor / Lead Auditor training.


How will I be assessed?

In-House Courses
For In-House courses, the Tutor will contact the Course Organiser in advance to discuss the programme in more detail in order to tailor it specifically to the organisation.

Course Manual
Delegates will receive a very comprehensive course manual.

Kevina O’Donoghue

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Kevina O’Donoghue

Duration: 1 day
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