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Effective Cleaning of a Cleanroom

Developing an effective cleaning program for our cleanroom is critical in achieving overall product quality no matter what the cleanroom industry from pharmaceutical to medical device, electronics to healthcare. This entails establishing a cleaning procedure, choosing the correct disinfectants and validating the chosen chemicals. It also entails deciding on cleaning frequencies, schedules and responsibility, establishing appropriate application methods, ensuring safe handling, preparation and disposal of disinfectants, demonstrating and verifying efficacy, training personnel and maintaining cleaning records. Cleaning cleanrooms is difficult and often underappreciated which can lead to poor adherence to cleaning protocols and inconsistent results. The aim of this programme is to give delegates the tools and understanding they need to:
  1. implement an effective cleaning program for their cleanroom
  2. choose suitable disinfectants based on varying disinfectant characteristics and current contamination
  3. perform effective cleaning methods
  4. understand the important role effective cleaning has on our cleanroom

Delivery Mode

  • Customised
    In-Company
    Programmes

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Accreditation
Course Code
LS013

Duration
1 training day

What's covered?

The programme offers the participants, an opportunity to work together in establishing an effective cleaning plan in compliance with the ISO, USP, EUGMP and FDA standards as well as exploring challenges, solving problems and finding solutions to contamination issues that could potentially have an impact on the final product and in turn, on the business and people working within it.

This course will cover;

  • Why cleanrooms need to be cleaned and the impacts if effective cleaning is not performed.
  • What an effective cleaning SOP should entail.
  • Cleaning language i.e. cleaning versus sanitisation versus disinfection.
  • Disinfectants available and how to choose the appropriate disinfectant for your cleanroom.
  • Cleanroom microbiology - ensuring a suitable disinfectant is used to eliminate the contamination present.
  • How to deal with residue build up.
  • Rotation of disinfectants.
  • Things to consider when handling, preparing and disposing of cleaning chemicals.
  • Cleaning methods for cleaning of surfaces, ceilings, walls, floor and equipment.
  • Regulations surrounding the effective cleaning of a cleanroom.

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

Who should participate?

  • Any person in the organisation who is directly involved in cleaning of cleanrooms
  • Personnel responsible for managing the cleanroom cleaning
  • Personnel who have responsibility for choosing disinfectants for use within the cleanroom
  • Personnel who work on investigations where a contributory factor is related to cleaning or cleaning disinfectants.

What will I learn?

Participants achieve the following learning outcomes from the programme;

  • Understand why cleanrooms need to be cleaned and the impacts if effective cleaning is not performed.
  • Identify what an effective cleaning SOP should entail.
  • Understand the cleaning language i.e. cleaning versus sanitisation versus disinfection.
  • Understand the array of disinfectants available and how to choose the appropriate disinfectant for your cleanroom.
  • Understand cleanroom microbiology to ensure that a suitable disinfectant is used to eliminate the contamination present.
  • Understand how to deal with residue build up.
  • Understand the regulations surrounding the rotation of disinfectants.
  • Important things to consider when handling, preparing and disposing of cleaning chemicals.
  • Understand the correct cleaning methods for cleaning of surfaces, ceilings, walls, floor and equipment.
  • Perform practical cleaning of surfaces within a cleanroom.
  • Examine different cleaning systems available.
  • Know the regulatory requirements surrounding cleanroom cleaning.

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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