OVERVIEW
The Critical Role of Cleanroom Awareness
Contamination in cleanrooms costs electronics and pharmaceutical manufacturers millions annually. Even small defects in wafers, components, or drug products ranging from cents to thousands of dollars can escalate costs tenfold if particles contaminate the environment.
Airborne contaminants harm production yields, product quality, reliability, and customer satisfaction, ultimately hurting profits.
Industry standards like ISO 14644 require robust cleanroom control programs, including ongoing training for all personnel and proper record-keeping.
This Workshop Will Help You:
- Recognize cleanroom risks in electronics & pharma
- Identify contamination control challenges
- Develop & audit a cleanroom control plan
- Implement & verify compliance with ISO 14644 & GMP
WHO SHOULD ATTEND
Managers, Engineers, Technicians, Supervisors—any personnel handling cleanroom-sensitive items.
Relevant Industries:
- Electronics Manufacturing: Semiconductor, PCB Assembly, Wafer Fabrication, Disk Drive, Fiber Optics
- Pharmaceutical: GMP-regulated production
TRAINING METHODOLOGY
Seminar consists of 2 days training workshop.
Workshop 1
- Cleanroom Fundamentals
- Cleanroom Design & Construction
Workshop 2
- Cleanroom Materials
- HVAC & Filtration systems
- Cleanroom Testing
- Utilities
Fundamental workshop will give an insight of cleanroom purpose and requirements and why cleanroom environment is required.
This module will examine critical selection criteria for determining the most efficient and cost-effective clean room construction technique.
COURSE OUTLINE
Day 1 : 9.00am – 5.00pm
MODULE 1: CLEANROOM TECHNOLOGY OVERVIEW, CONTAMINATION & BUILD
- 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.
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
MODULE 5:
- Others ISO14644 Series for special applications (Part 6,7 to Part 16)
MODULE 6:
- ESD related to Cleanroom
- ESD Hazard to Cleanroom Environment
- ESD Hazard to Cleanroom Product
MODULE 7:
- Cleanroom Safety
- Hazards inside Cleanroom
- Evacuation Procedure
