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How clean do I need the cleanroom to be?

The cleanroom classification needed depends on specifications for operations to be conducted within. Research in your specific field will probably provide a specification or at least a general guideline.

Key Elements of Contamination Control

We will look at several areas of concern to get a better idea of the overall picture of contamination control. These are the things that need to be considered when providing an effective contamination control program.

Microelectronics Cleanroom

Semiconductor and electronics industry are essential in this era as the consumer electronics are becoming the basic necessity for people around the world. Consumer electronics are used every day, commonly in communications, office productivity and also for entertainment purpose. In an electronics manufacturing plant, cleanrooms are fundamental to the production line so that the goods fabricated are of high reliability.

 

Most of the semiconductor, microelectronics, electronics, automotive industry need cleanrooms that follow ISO 14644-1 or its predecessor, FED-STD-209E cleanroom standards.

 

Class

maximum particles/m3

FED STD 209E
equivalent

≥0.1 µm

≥0.2 µm

≥0.3 µm

≥0.5 µm

≥1 µm

≥5 µm

ISO 1

10

2.37

1.02

0.35

0.083

0.0029

 

ISO 2

100

23.7

10.2

3.5

0.83

0.029

 

ISO 3

1,000

237

102

35

8.3

0.29

Class 1

ISO 4

10,000

2,370

1,020

352

83

2.9

Class 10

ISO 5

100,000

23,700

10,200

3,520

832

29

Class 100

ISO 6

1.0×106

237,000

102,000

35,200

8,320

293

Class 1,000

ISO 7

1.0×107

2.37×106

1,020,000

352,000

83,200

2,930

Class 10,000

ISO 8

1.0×108

2.37×107

1.02×107

3,520,000

832,000

29,300

Class 100,000

ISO 9

1.0×109

2.37×108

1.02×108

35,200,000

8,320,000

293,000

Room air



 Recommended CLIN ® systems for microelectronics cleanroom:

Ceiling: Ceiling Grid System

Wall Partition: Stud Wall Partition System / “Z” Lock Flush Wall Partition System

   * Static Dissipative Steel Skins

Door: Swing Door / Sliding Door

Lighting: Teardrop Lighting

Pass Box: Stainless Steel / EG Steel c/w Powder Coat

Air Shower Unit: Stainless Steel / EG Steel c/w Powder Coat

Filtration: HEPA Filter / ULPA Filter / Fan Filter Unit

Raised Floor: Aluminium Raised Floor System

 Project Reference:

• Western Digital Sdn. Bhd.
• Ibiden Electronics Malaysia Sdn. Bhd.
• Honda Malaysia Sdn. Bhd.

GMP Compliant Cleanroom

GMP or Good Manufacturing Practice guidelines provide guidance for manufacturing, testing and quality assurance as the respective manufacturer must meet the minimum requirements in the guidelines to assure that the products are of high quality and do not pose any risk or harm to the consumer or public.

 

Pharmaceutical, healthcare, chemical and food industry are some of the examples of industries that need to follow GMP guidelines. The cleanroom should be compliant with GMP EU Classification.

 

 

Class maximum particles/m3
At Rest At Rest In Operation In Operation
0.5 µm 5 µm 0.5 µm 5 µm
Grade A 3,500 0 3,500 0
Grade B 3,500 0 350,000 2,000
Grade C 350,000 2,000 3,500,000 20,000
Grade D 3,520,000 29,000 n/a n/a



 Recommended CLIN® systems for GMP compliant cleanroom:

Ceiling: Frame Flush Ceiling System / “Z” Lock Flush Ceiling System

Wall Partition: Frame Flush Wall Partition System / “Z” Lock Flush Wall Partition System

   * comes with Coving and Pharma-type Corner Post

Door: Pharma-type Swing Door / Sliding Door

Lighting: Recessed Lighting

Pass Box: Stainless Steel / EG Steel c/w Powder Coat

Air Shower Unit: Stainless Steel / EG Steel c/w Powder Coat

Filtration: HEPA Filter / ULPA Filter / Fan Filter Unit

 Project Reference:

• B. Braun Medical Industries Sdn. Bhd.
• Haemonetics Malaysia Sdn. Bhd.
• Ambu Sdn. Bhd.

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CLIN ® "Resources" page is for individuals seeking information on cleanrooms and controlled environments. Find Cleanroom News, Discussion Forums, Cleanroom Cleaning Recommendations, Cleanroom Terminology, Cleanroom Directory, and more.

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Every effort is made to keep the website up and running smoothly. However, CLIN ® takes no responsibility for, and will not be liable for, the website being temporarily unavailable due to technical issues beyond our control.

Raised Floor System

We are the exclusive agent for HAE KWANG RAISED FLOOR SYSTEMS in Malaysia.

 

Hae Kwang is a world leader in the die casting and precise manufacturing of access floor systems for high technology applications through continuous research and develops its own products.

 

Hae Kwang maintains a worldwide reputation for supplying clean, precision made access flooring that meets and exceeds the stringent specification for cleanrooms and computer centres.

We are experienced in Cleanroom Solutions

Call Us for Consultation +6(04) 398 1778

About CLIN

Cleanroom Industries Sdn. Bhd. was founded in 1999 as a pioneer manufacturer in Malaysia specializing in design and manufacture of a full range of cleanroom-related architectural products for cleanroom applications up to Class 1 cleanliness.

Awards & Recognitions

ISO 9001 Malaysia Power Brand Super Excellent Brand Sirim QAS Made in Malaysia Asia Pacific International Honesty Enterprise Keris Award