INTRODUCTION

Controlled and certified cleanrooms are essential in the medical devices industry when sterilisation is part of the  manufacturing process. Cleanrooms are highly controlled environments, where air contaminants level are controlled and certain physical and microbiological requirements need to be met. Without effective control, contamination can wreak havoc on the products and processes. As medical devices broach into higher risk category, control of airborne particles and surface contamination becomes a constant challenge.

This leads to manufacturing facilities leaning towards a higher cleanroom level classification then the bare minimum to future proof their built. Good cleanroom practices will have a significant impact on the quality of products being produced and the processes performed in the cleanroom. The internationally recognised standards on cleanroom and its associated environments; ISO14644 and ISO14698 are both specifically reference in the ISO13485 2016 for work environment and contamination control where it categorically states that organisation are required to maintain the necessary cleanliness during assembly or packaging.

COURSE OBJECTIVES

Participants will be introduced to the principles and methodology of air cleanliness classification in cleanrooms, the prerequisite and optional tests, changing room best practices with reference to the standard, implementation of the standard’s specified requirements during operation and an understanding of biocontamination, principals for its control and monitoring. The followings with reference to the ISO 14644 and ISO 14698 are covered:

• Airborne contaminants measurement and cleanroom classification;
• Mandatory test, supportive tests and monitoring of cleanrooms performance;
• Cleanroom Validation overview – built stages, occupancy state and qualification stages;
• Changing room control, configuration and facilities;
• Maintaining operational cleanliness;
• Biocontamination sampling for control/ monitoring.

COURSE OUTLINE

• Classification of air cleanliness by particle concentration
• Monitoring to provide evidence of cleanroom performance
• Cleanrooms test methods (sampling of supporting tests)
• Overview of cleanroom design, construction and start-up
• Cleanroom operations and control practices.
• Formal system and biocontamination monitoring.

COURSE BENEFITS

At the end of the session, participants will;

• Gain a practical perspective understanding on cleanrooms control and practices.
• Be knowledgeable on the monitoring of cleanrooms performance to the standard’s requirements.
• Be aware of the requisite requirements of cleanrooms which reflect current “state of the art”.

DURATION

Two (2) full days

MODE OF TRAINING

Remote Online Training or Classroom Training

TARGET AUDIENCE

This programme is designed for all levels and functions of an organization who needs to gain operational practical knowledge and desires to be compliant with regards to the ISO requirements on cleanroom and its associated environments in practice with reference to:

• ISO 14644-1: 2015 Cleanroom and associated control environment: Classification of air cleanliness
• ISO 14644-2: 2015 Cleanroom and associated control environment: Monitoring
• ISO 14644-3: 2019 Cleanroom and associated control environment: Test methods
• ISO 14644-4: 2022 Cleanroom and associated control environment: Design, construction and start-up
• ISO 14644-5: 2004 Cleanroom and associated control environment: Operations
• ISO 14698-1: 2003 Cleanroom and associated control environment: Biocontamination control