Cleanroom Standards and Practices in Manufacturing

The Workshops will help you to:
• Understand Cleanroom impact in the electronics & pharmaceutical environment
• Determine Cleanroom controls problems
• Establish & implement techniques to measure and audit your plant and Cleanroom Control Plan
• Establish, implement and verify a Cleanroom control plan as per ISO14644 &GMP

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).

Day 1 :  9.00am - 5.00pm
Introduction to Cleanroom
MODULE 1: 
•    Overview of Cleanroom
•    Definition and purpose of a cleanroom
•    Importance of cleanrooms in the manufacturing industry
•    Types of Cleanrooms
•    Different classes of cleanrooms (ISO, GMP standards)
•    Application of cleanrooms in different industries (Pharmaceutical, Semiconductor, Food, etc.

Cleanroom Standards
MODULE 2: 
•    ISO Cleanroom Standards
•    ISO 14644 series overview
•    Classification of air cleanliness by particle concentration
•    GMP (Good Manufacturing Practice) Standards
•    GMP guidelines for cleanroom operations
•    Differences between ISO and GMP standards
•    Industry-Specific Standards
•    Pharmaceutical standards (EU GMP, FDA)
•    Electronics and semiconductor cleanroom standards

Cleanroom Controls
MODULE 3: 
•    Environmental Control
•    Temperature and humidity control
•    Pressure differentials (positive and negative pressure environments)
•    Airflow Systems
•    HEPA filters and ULPA filters
•    Laminar and turbulent flow
•    Air exchange rates and their significance
•    Contaminant Sources and Control
•    Common contaminants in cleanrooms (particles, microbes)
•    Sources of contamination (personnel, equipment, processes)
•    Personnel Control
•    Proper gowning and behavior in cleanrooms
•    Training and certification requirements for cleanroom personnel

Cleanroom Monitoring
MODULE 4: 
•    Air Quality Monitoring
•    Airborne particulate monitoring (particle counters, sampling protocols)
•    Microbial monitoring (surface sampling, airborne microbial sampling)
•    Environmental Monitoring Systems (EMS)
•    Continuous monitoring of temperature, humidity, and pressure
•    Data logging and alarm systems for critical parameters
•    Monitoring Procedures and Protocols
•    Frequency of monitoring
•    Interpretation of monitoring results and corrective actions
•    Regulatory requirements for documentation and reporting

Cleanroom Maintenance
MODULE 5:
•    Routine Cleaning and Sanitization
•    Cleaning agents and their appropriate use
•    Frequency and methods of surface and floor cleaning
•    Specialized equipment for cleanroom cleaning (vacuum systems, cleanroom wipes)
•    Filter Maintenance and Replacement
•    HEPA/ULPA filter testing (DOP/PAO testing)
•    Replacement intervals and procedures
•    Equipment Maintenance
•    Regular calibration and validation of cleanroom equipment
•    Preventative maintenance schedules for HVAC systems, monitoring systems, etc.
•    Sterilization and Disinfection
•    Autoclaving, chemical sterilization, and other sterilization methods
•    Frequency and validation of sterilization practices

Day 2 :  9.00am - 5.00pm
Cleanroom Design & Construction
MODULE 6:
•    Impact of cleanroom design on product quality and process integrity
•    Key objectives of cleanroom design
•    Particle count levels for each ISO classification
•    Cleanroom classifications based on process requirements
•    Industry-Specific Requirements:  Pharmaceutical, electronics, and healthcare standards for cleanroom design
•    Contamination Control Strategies
•    Airflow Systems and Design
•    Room Layout and Zoning
•    Surface Materials and Finishes

HVAC & Filtration systems
MODULE 7:
•    HVAC Design Requirements
•    Filtration Systems
•    Environmental Control

Cleanroom Materials 
MODULE 8:
•    Construction Planning
•    Construction Material
•    Modular Cleanroom Construction
•    Validation Phases
•    Testing and Certification
•    Regulatory compliance and documentation (GMP, ISO)

Cleanroom Best Practices
MODULE 9:
•    Contamination Prevention Techniques
•    Proper gowning procedures (donning and doffing)
•    Behavioral 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

Auditing and Compliance
MODULE 10:
•    Internal and External Audits
•    Preparing for audits (GMP, FDA, ISO)
•    Audit checklists and common findings
•    Corrective and Preventive Actions (CAPA)
•    Root cause analysis for contamination or non-compliance
•    Implementing and documenting CAPA
•    Training and Continuous Improvement
•    Ongoing staff training for cleanroom protocols
•    Continuous improvement initiatives and Kaizen in cleanroom environments

Case Studies, Practical Scenarios, Conclusion and Q&A
MODULE 11:
•    Cleanroom Contamination Incident
•    Analysis of the cause, impact, and resolution
•    Successful Implementation of a New Cleanroom Standard
•    Challenges, solutions, and outcomes
•    Recap of Key Concepts
•    Interactive Q&A Session

Workshop 1 
Cleanroom Fundamentals
Cleanroom Standards
Cleanroom Control
Cleanroom Maintenance

Workshop 2
Cleanroom Design & Construction
HVAC & Filtration systems
Cleanroom Materials
Cleanroom Monitoring
Cleanroom Best Practices
Auditing and Compliance
Case Studies, Practical Scenarios, Conclusion and Q&A

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.

VIKNESH SELVARATNAM
i NARTE certified ESD Engineer (Certificate Number : ESD-00511-E)
Bachelor of Engineering (Electrical)
Universiti Teknologi Malaysia
HRDF Certified trainer (Certificate No: 7271)

Mr. Viknesh Selvaratnam is a distinguished ESD and Cleanroom Consultant, currently advising numerous contract manufacturing companies across Malaysia. He is an iNARTE Certified ESD Engineer, recognized as one of the first 28 professionals in Malaysia to achieve this certification from the Electrostatic Discharge Association (ESDA).

Holding a Bachelor\\\'s Degree in Electrical/Electronics, Mr. Viknesh brings nearly three decades of experience in electrostatics, with extensive exposure to the manufacturing sector. His expertise spans industries such as wafer/silicon manufacturing, semiconductors, electronics, and fiber optics, making him a sought-after authority in ESD and cleanroom management.

Through his career, Mr. Viknesh has honed training methodologies tailored to meet the needs of entry-level learners and professionals applying these skills in their daily operations. Drawing on his vast industry experience, he has identified common challenges in basic electrostatic discharge (ESD) principles and cleanroom environmental controls, often impacting manufacturing efficiency and quality.

Mr. Viknesh has conducted numerous training programs focused on ESD and cleanroom design, guiding organizations in ESD implementation, auditing, and control systems. His consultancy extends to the technical application of ESD models and cleanroom management to enhance operational compliance and mitigate risks.

He has played a pivotal role in establishing comprehensive ESD control programs and cleanroom management systems for contract manufacturers in Penang, Johor, Melaka, and Selangor. Additionally, he has provided ESD consultancy and training, cleanroom design consultancy, and ISO 17025 calibration guidance for companies across Kuala Lumpur, Penang, Selangor, Ipoh, Negeri Sembilan, Melaka, Pahang, Kedah, and Johor.

Upon successful completion of this program, you will receive a Certificate of Achievement.

1. By Credit card: You can opt to register and pay online with our latest payment integration system through our website.
2. Bank Transfer- You can also opt to bank transfer payment via local / international banks. Please send payment slip as proof of payment.
3. HRD Corp Claimable Courses Skim Bantuan Latihan Khas - Applicable to Malaysian Employer Only

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