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Factors That Contribute To Quality Products:: Case Examples (Bioclean & Semiconductor Rooms)

The document discusses the requirements for clean rooms and factors that contribute to quality products. It notes that the manufacturing environment is critical for product quality and must be optimized for light, temperature, humidity, air movement, and contamination. It states that uncontrolled environments can lead to product degradation and loss of profit. The document distinguishes between bioclean areas like pharmaceutical facilities and industrial clean rooms like semiconductor manufacturing.

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92 views1 page

Factors That Contribute To Quality Products:: Case Examples (Bioclean & Semiconductor Rooms)

The document discusses the requirements for clean rooms and factors that contribute to quality products. It notes that the manufacturing environment is critical for product quality and must be optimized for light, temperature, humidity, air movement, and contamination. It states that uncontrolled environments can lead to product degradation and loss of profit. The document distinguishes between bioclean areas like pharmaceutical facilities and industrial clean rooms like semiconductor manufacturing.

Uploaded by

CIVIL
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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www.PDHcenter.com PDH Course M143 www.PDHonline.

org

PART – V CASE EXAMPLES (BIOCLEAN & SEMICONDUCTOR ROOMS)

The requirements for clean rooms depend on the classification and use.

Factors that contribute to quality products:

• Starting materials and packaging materials

• Validated processes

• Personnel

• Procedures

• Equipment

• Design and quality of premises

• Manufacturing environment
• Inadequacies in the above factors will lead to sub-standard products.

The manufacturing environment is critical for product quality. The environment optimization

include

• Light

• Temperature

• Humidity

• Air movement

• Microbial contamination

• Particulate contamination

Uncontrolled environment can lead to product degradation /Loss of product and profit

The bio-clean areas include the pharmaceutical facilities, animal laboratories, radioisotopes lab,

research laboratories, surgical theatres etc while the industrial clean room could be the

semiconductor manufacturing, electronic assembly, aerospace assembly etc. etc. Clean rooms in

the industrial application such as microelectronic semiconductor business are somewhat different

than those in the bio-clean applications.

Page 45 of 61

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