CONTAMINATION CONTROL IN CLEANROOM

INTRODUCTION CONTAMINATION CONTROL IN CLEANROOM

Cleanroom contamination remains a leading cause of costly failures in the electronics and pharmaceutical industries, resulting in millions of dollars in losses each year. The damage from contaminated wafers, components, pharmaceutical products, or packaging can range from a few cents to thousands of dollars per incident. In cleanroom environments, even minor contamination can exponentially increase those costs.

Airborne particles not only compromise production yields but also impact product quality, reliability, and customer satisfaction, all of which directly affect your bottom line.

Global industry standards, including ISO 14644, emphasize the critical need for a robust cleanroom control program. This includes comprehensive initial and recurrent cleanroom training for every individual with access to cleanroom areas, along with thorough documentation of all training activities.

Investing in individual cleanroom training is not just a compliance requirement, it’s a strategic decision that protects your products, safeguards your reputation, and maximizes profitability.

LEARNING OUTCOMES

By the end of the session, the participants will be able to:

1.  Understand the Critical Role of Cleanroom Control – Gain insight into how cleanroom practices directly impact product quality, reliability, and compliance in electronics and pharmaceutical environments.
2. Identify and Address Cleanroom Control Challenges – Learn to recognize common cleanroom control issues and implement effective strategies to mitigate contamination risks.
3. Develop Measurement and Audit Techniques -Acquire practical skills to measure cleanroom performance and conduct audits of your facility and Cleanroom Control Plan for continuous improvement.

WHO SHOULD ATTEND

Managers, Engineers, Technicians, Supervisors overall any personnel handling Cleanroom sensitive items.  Relevant for Semiconductor, PCB Assembly, Disk drive, Wafer Fabrication, Fiber Optics, Electronics manufacturing industries and pharmaceutical industries (GMP).

METHODOLOGY

Seminar consists of 2-day training workshop.

Workshop 1 

• Cleanroom Fundamentals
• Cleanroom Standards
• Cleanroom Control
• Cleanroom Maintenance

Workshop 2

• Cleanroom Test Methods & Operations
• HVAC & Filtration systems
• Cleanroom Materials
• Cleanroom Monitoring
• Cleanroom Best Practices
• Conclusion and Q&A

Fundamental Cleanroom Workshop Overview

This workshop provides a comprehensive understanding of the purpose, importance, and key requirements of cleanroom environments. Participants will gain valuable insights into why cleanroom controls are essential for maintaining product quality and regulatory compliance in critical industries such as electronics and pharmaceuticals.

Additionally, the module explores critical selection criteria for designing and constructing cleanrooms. It focuses on identifying the most efficient and cost-effective construction techniques, helping organizations make informed decisions that balance performance, compliance, and budget considerations

COURSE OUTLINE

Day 1 :  9.00am – 5.00pm

CLEANROOM TECHNOLOGY OVERVIEW, CONTAMINATION & BUILD

MODULE 1:  Cleanroom Technology and its Application

• The history of cleanroom.
• Definitions of cleanroom and  what levels of cleanliness.  

 How  clean is clean?

• Why cleanroom is required for special industry or specific operations.
• Cleanroom applications for different types of industry; semiconductor, pharmaceutical, optics, food, etc.

MODULE 2: Introduction to International Cleanroom Standards

• Federal 209 Version  E (FED209E).
• International Standard Organization- ISO14464.
• Others standard; Japan, UK.
• ISO 14644 series overview

MODULE 3: ISO14644 Series – Cleanroom and  Associated Controlled Environments

• ISO14644 – 1 : Classification of Air Cleanliness by Particle Concentration
  • Classification Table
  • Occupancy State
  • Classification Number
  • Number of Sampling Points and  Locations
• ISO14644 – 4 : Design, Construction and  Start-up
  • Planning and  Design
  • Cleanroom Class
  • Layout
  • Construction and  Start-up
  • Testing and  Commissioning
  • Documentation

Day 2 :  9.00am – 5.00pm

CLEANROOM OPERATION, MAINTENANCE SAFETY & CONTROL  

MODULE 4: ISO14644 Series – Cleanroom and  Associated Controlled Environments (cont.)

• ISO14644 – 3 : Test Methods
  • Required Test  (Airborne Particle Count)
  • Optional Test  (Air Flow, Pressure, Temperature, Humidity, Light, etc.)
  • Test  Report

• ISO14622 – 2:  Monitoring to Provide Evidence of Cleanroom Performance Related to Air Cleanliness by Particle Concentration
  • Schedule of testing to demonstrate compliance with particle concentration limits
  • Schedule of additional tests for all classes
  • Monitoring

• ISO14644 – 5 : Operations
  • Operational System 
  • Cleanroom 
  • Clothing 
  • Personnel
  • Stationary Equipment
  • Material  and  Portable Equipment
  • Cleanroom Cleaning

• Others ISO14644 Series for special applications
  • Part 6, Part 7  to  Part 16

• ESD Related to Cleanroom
  • ESD Hazard to Cleanroom Environment
  • ESD Hazard to Cleanroom Product

MODULE 5: Cleanroom Best Practices

• Contamination Prevention Techniques
• Proper gowning procedures (donning and doffing)
• Behavioural protocols to minimize contamination
• Material Flow and Handling
• Proper handling and storage of materials entering and exiting the cleanroom
• Minimizing contamination from raw materials, packaging, and products
• Waste Disposal Procedures
• Handling of hazardous and non-hazardous waste
• Regulatory compliance for waste disposal in cleanroom  environments

MODULE 6: Conclusion and Q&A

• Challenges, solutions, and outcomes
• Recap of Key Concepts
• Interactive Q&A Session