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ISO 14644-1; A Complete Guide - Edition

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ISO 14644-1: A Complete Guide - Edition



Course Overview

This comprehensive course provides a thorough understanding of the ISO 14644-1 standard, which defines the requirements for the design, construction, and operation of cleanrooms and associated controlled environments. Participants will gain the knowledge and skills necessary to implement and maintain a cleanroom that meets the ISO 14644-1 standard, ensuring a controlled environment for industries such as pharmaceuticals, biotechnology, and aerospace.



Course Objectives

  • Understand the principles and requirements of the ISO 14644-1 standard
  • Learn how to design, construct, and operate a cleanroom that meets the ISO 14644-1 standard
  • Understand the importance of contamination control and how to implement effective contamination control measures
  • Gain knowledge of the different types of cleanrooms and their applications
  • Understand the role of cleanroom personnel and their responsibilities
  • Learn how to conduct risk assessments and implement corrective actions
  • Understand the importance of ongoing monitoring and maintenance of the cleanroom


Course Outline

Module 1: Introduction to ISO 14644-1

  • Overview of the ISO 14644-1 standard
  • History and development of the standard
  • Key principles and requirements of the standard
  • Benefits of implementing the ISO 14644-1 standard

Module 2: Cleanroom Design and Construction

  • Principles of cleanroom design
  • Materials and finishes for cleanroom construction
  • Heating, ventilation, and air conditioning (HVAC) systems
  • Lighting and electrical systems
  • Flooring and wall finishes
  • Ceiling and roof construction

Module 3: Cleanroom Operations

  • Principles of cleanroom operations
  • Cleanroom personnel and their responsibilities
  • Gowning and degowning procedures
  • Cleanroom cleaning and disinfection
  • Waste management and disposal
  • Ongoing monitoring and maintenance of the cleanroom

Module 4: Contamination Control

  • Principles of contamination control
  • Sources of contamination
  • Contamination control measures
  • Air filtration systems
  • Cleanroom clothing and personal protective equipment (PPE)
  • Cleanroom cleaning and disinfection

Module 5: Cleanroom Classification and Monitoring

  • Principles of cleanroom classification
  • Cleanroom classification systems
  • Airborne particle monitoring
  • Microbial monitoring
  • Temperature and humidity monitoring
  • Ongoing monitoring and maintenance of the cleanroom

Module 6: Risk Assessment and Corrective Action

  • Principles of risk assessment
  • Identifying and assessing risks
  • Implementing corrective actions
  • Verifying the effectiveness of corrective actions
  • Ongoing monitoring and maintenance of the cleanroom

Module 7: Cleanroom Validation and Verification

  • Principles of cleanroom validation and verification
  • Validation and verification procedures
  • Testing and certification of cleanrooms
  • Ongoing monitoring and maintenance of the cleanroom

Module 8: Cleanroom Maintenance and Repair

  • Principles of cleanroom maintenance and repair
  • Maintenance and repair procedures
  • Cleanroom shutdown and startup procedures
  • Ongoing monitoring and maintenance of the cleanroom


Course Features

  • Interactive and engaging: The course includes interactive elements, such as quizzes, games, and discussions, to keep participants engaged and motivated.
  • Comprehensive and personalized: The course covers all aspects of the ISO 14644-1 standard and provides personalized feedback and support to participants.
  • Up-to-date and practical: The course is updated regularly to reflect the latest developments in cleanroom technology and provides practical examples and case studies.
  • Real-world applications: The course provides real-world examples and case studies to illustrate the application of the ISO 14644-1 standard in different industries.
  • High-quality content: The course content is developed by experts in the field of cleanroom technology and is reviewed regularly to ensure that it is accurate and up-to-date.
  • Expert instructors: The course instructors are experts in the field of cleanroom technology and have extensive experience in teaching and training.
  • Certification: Participants receive a certificate upon completion of the course, issued by The Art of Service.
  • Flexible learning: The course is available online and can be completed at any time, allowing participants to learn at their own pace.
  • User-friendly: The course is designed to be user-friendly and easy to navigate, with clear instructions and minimal technical requirements.
  • Mobile-accessible: The course is accessible on mobile devices, allowing participants to learn on-the-go.
  • Community-driven: The course includes a community forum where participants can ask questions, share experiences, and connect with other learners.
  • Actionable insights: The course provides actionable insights and practical advice that participants can apply in their own workplaces.
  • Hands-on projects: The course includes hands-on projects and activities that allow participants to apply their knowledge and skills in a practical way.
  • Bite-sized lessons: The course is divided into bite-sized lessons that can be completed in a short amount of time, making it easy to fit into a busy schedule.
  • Lifetime access: Participants have lifetime access to the course materials and can review them at any time.
  • Gamification: The course includes gamification elements, such as points and badges, to make learning fun and engaging.
  • Progress tracking: The course includes progress tracking features that allow participants to track their progress and stay motivated.
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