Cleanroom Microbiology

This programme offers learners a structured and operational understanding of cleanroom environmental microbiology monitoring. The content is aligned to ISO (14698, 17141, 14644-1, 14644-2) and regulatory (Eudralex) requirements for real-world cleanroom operations, helping learners identify risks, plan monitoring effectively and address microbial and particulate issues with confidence. 

Topics include: 

• Introduction to Microbiology 
• Cleanroom Validation (At Built, At Rest & In Operation) 
• Environmental Monitoring Programme design 
  • Selecting appropriate microbiological sampling methods  
  • Identifying sampling locations through risk assessment  
  • Creating a robust sampling map  
  • Defining suitable sampling frequencies  
  • Establishing alert and action limits 
  • Analysing and Interpreting microbial monitoring data  
  • Managing out of specification results 
  • Conducting effective investigations 
  • Applying best practices in reporting, trending, and documentation  
• Core principles of Particulate Monitoring  
• Product Testing - Bioburden & LAL testing 

This course is suitable for individuals participating in new cleanroom design and construction projects, personnel involved or managing environmental monitoring activities within a cleanroom or individuals conducting investigations into out of specification results  

Typical participants include: 

• Personnel engaged in new cleanroom build projects 
• Those involved in cleanroom monitoring or testing 
• Individuals responsible for environmental monitoring results or investigations 

A good standard of written and spoken English is important to engage effectively with this programme. 

On successful completion of this course, learners will be able to: 

• Understand the standard and regulatory expectations of environmental monitoring within cleanrooms 
• Understand cleanroom validation and requalification requirements
• Establish and maintain an effective Environmental Microbiological and Particulate Monitoring Programme 
• Apply appropriate sampling methods and determine sampling frequencies 
• Interpret microbial and particulate monitoring data accurately 
• Set and review alert and action limits 
• Conduct effective investigations and manage out of specification results 
• Document findings clearly and recommend suitable corrective actions 

These outcomes equip learners with the skills, knowledge and capabilities required to strengthen cleanroom monitoring practices and support contamination control. 

This programme is delivered by tutors with extensive cleanroom microbiology and contamination control expertise. 
Each tutor brings a wealth of industry experience, sector-specific insights and a passion for practical training. Their focus is on building learner confidence through engaging, hands-on exercises and personalised support. 

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 and evolved into the Quality and Regulatory areas of the Life Science Industry.

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.

This programme is led by a highly experienced tutor, with extensive industry expertise, ensuring learners benefit from realworld insight and experience and allowing learners to gain knowledge grounded in years of practical and technical understanding. 

Support Includes: 

• Pre-training consultation for in-company courses to tailor content to organisational needs 
• Emphasis on industry specific application enriched by the tutor’s comprehensive knowledge and longstanding professional experience that reinforce key concepts and encourage active participation. 
• Access to comprehensive course material that is regularly reviewed and updated to reflect the latest industry standards and guidance. 
• Live training is available virtually or delivered onsite to suit the needs of the team 
• Real-time support from expert Tutors 

Class sizes are generally limited to 12-15 participants to support personalised learning and individual support.