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Learn the Benefits of a Cleanroom

New USP 797 and USP 800 manufacturing regulations may require you to install a cleanroom within your plant to minimize cross-contamination to your workers and environment. Understanding your duties can help assure your workers safety and your company’s compliance to the latest regulation.

Above: Modular Cleanroom

What is a Cleanroom?

Simply put, cleanrooms are either flexible or fixed rooms in which you can control the level of outside air your application is exposed to. With the main cause of contamination in the air are the people and the process. The purpose of a cleanroom is to ensure a certain level of cleanliness for your process.

How Cleanrooms Work

There are two types of cleanrooms; positive-pressure and negative-pressure. Positive-pressure cleanrooms are the most common amongst the two.

Positive-pressure cleanrooms are designed to keep contaminants from entering the room. Typically, the air enters the cleanroom from the ceiling after being filtered through a HEPA filter. The HEPA filter captures particles not visible to the human eye and removes particles as small as .3 to .5 microns. This air pressure in the room is kept greater than the air outside the environment. The contaminants and air then get forced out of the cleanroom through vents in the the lower portions of the walls (or recirculated back through the fan/filter units), keeping contaminants out.

Negative-pressure cleanrooms, on the other hand, are designed to keep contaminants from getting into the external environment. Negative-pressure rooms are more concerned with workers safety and not over-exposing external environments to toxic chemicals. The air pressure is consistently being drawn into the cleanroom through vents, keeping contaminants from leaving the cleanroom.

Things to Consider

There are a lot of determining factors when choosing the proper cleanroom classification. Every industry is unique and has guidelines to follow. For example, the medical device packaging industry requires a default ISO 7 cleanroom (or class 10,000). But your industry may require a higher cleanliness level. The most important thing to keep in mind is the number of particles you have to remove from the air and what your industry cleanliness default is.

Industry cleanliness levels are determined by the International Organization for Standardization (ISO). The lower the ISO number, the cleaner the environment. ISO Class 1- 5 are based on air flow through the room (measured in meters per second). ISO Class 6-9 are measured on air changes per hour.

These are a few questions you should ask yourself in order to determine what cleanliness level is right for you:

  • What are my sources of contamination?
  • What size particles do I need to filter out?
  • How much air do I have to circulate to get that contamination out?

Below is are guides to help you understand the different ISO clean levels.

ISO 14644-1 Cleanroom Standards

ISO 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

 

 

 

 

 

 

ISO 2

100

24

10

4

 

 

 

 

ISO 3

1,000

237

102

35

8

 

 

Class 1

ISO 4

10,000

2,370

1,020

352

83

 

 

Class 10

ISO 5

100,000

23,700

10,200

3,520

832

29

 

Class 100

ISO 6

1,000,000

237,000

102,000

35,200

8,320

293

 

Class 1,000

ISO 7

 

 

 

352,000

83,200

2,930

 

Class 10,000

ISO 8

 

 

 

3,520,000

832,000

29,300

 

Class 100,000

ISO 9

 

 

 

35,200,000

8,320,000

293,000

 

Room Air


BS 5295 Cleanroom Standards

 

maximum particles/m3

Class

>=0.5 µm

>=1 µm

>=5 µm

>=10 µm

>=25 µm

Class 1

3,000

 

0

0

0

Class 2

300,000

 

2,000

30

 

Class 3

 

1,000,000

20,000

4,000

300

Class 4

 

 

20,000

40,000

4,000

 

What type of Cleanroom is right for you?

There are two options when it comes to cleanroom designs; fixed and modular.

Fixed cleanrooms are built into your facility structure and sit in place. Once assembled, they are fixed to its location and can only be moved by removing and rebuilding a new structure.

Modular cleanrooms are meant to be flexible. They are meant to be moved and rebuilt as needed. With a modular cleanroom, one can expand and customize as needed without starting from scratch. It also allows for more flexibility on design since its more of a standalone option versus having to modify it to fit around existing pipework and structures.

There is a lot of detail and planning that goes into selecting the proper cleanroom for your operation. Contact an exposure control expert to help you understand what is right for you.

About Our Cleanrooms

Kalyx Scientific can help you design and manufacture fixed or modular cleanrooms and cleanroom building components that service the specific requirements of your industry.

Our products are used by many of the world's leading manufacturers and research institutions due to the quality and flexibility of our products as well as our firm's extensive experience, comprehensive product line, and nationwide installation.

About Kalyx Scientific

In addition to cleanrooms, Kalyx offers a wide variety of exposure control products to keep your environment and workers safe. We have over 20 years of experience serving the Healthcare, Pharmaceutical, Biomedical, Biotech and University industries with high quality, proven products and systems. Our systems are USP 797, USP 800, cGMP and NIOSH compliant.

In addition to quality products and systems, Kalyx Scientific also offers services including installation, user training, preventive maintenance, validation and qualification documentation, and Factory and Site Acceptance Tests (FAT/SAT).

 

 

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