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What does cleanroom mean exactly?

Cleanrooms are rooms with high hygiene requirements meeting strict standards, are normally pressurised and have sterile comfort air conditioning systems to minimise the amount of germs in the air. Special furniture, walls, suspended ceilings and floors are used to maintain a high level of cleanliness.

In such rooms, the air is filtered several times to remove dust and other contaminants that could damage sensitive equipment or patients.

In cleanrooms, the following are regulated:

AIR SOLIDS CONTENT

TEMPERATURE

PRESSURE RELATIVE TO THE ENVIRONMENT

HUMIDITY

PLATE COUNT

In what cases is it needed?

PRECISION MECHANICS

(precision engineering, aviation industry, clock- and watchmaking)

COMPUTER & HARDWARE MANUFACTURING

MICROBIOLOGY

PHARMACEUTICALS

MANUFACTURE OF FOOD AND NUTRITIONAL PRODUCTS

SURGERY

AREAS OF THE PLASTICS INDUSTRY

OPTICS

OTHER TECHNOLOGIES

The degree of cleanliness of a cleanroom is determined not only by the cleanliness of the air brought in from outside, but also by the sources of pollutants and germs inside. This is achieved by using the right choice of material quality (low surface roughness) for cleanroom components and by optimally structuring the production sequences (material flow and personnel traffic).

In what cases is it needed?

PRECISION MECHANICS

(precision engineering, aviation industry, clock- and watchmaking)

COMPUTER & HARDWARE MANUFACTURING

MICROBIOLOGY

PHARMACEUTICALS

MANUFACTURE OF FOOD AND NUTRITIONAL PRODUCTS

SURGERY

AREAS OF THE PLASTICS INDUSTRY

OPTICS

OTHER TECHNOLOGIES

The degree of cleanliness of a cleanroom is determined not only by the cleanliness of the air brought in from outside, but also by the sources of pollutants and germs inside. This is achieved by using the right choice of material quality (low surface roughness) for cleanroom components and by optimally structuring the production sequences (material flow and personnel traffic).

ISO 14644

The standard distinguishes nine purity classes from "ISO 1" to "ISO 9". The standard gives a maximum number of particles between 0.1 μm and 5 μm per cubic metre of air. The following table summarises in detail the particle number in each class.

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GMP

It is mainly used in the pharmaceutical and food industries. It covers a wide range of issues, from hygiene and safety to the basic requirements for the organisation of production, the control of technology, the production of uniform, high-quality produce and the marketing of produce. GMP is a guide, not a standard, and its use is voluntary.

Click on image to enlarge

Cleanrooms are divided into 4 different classes by GMP:

Class "A": High-risk work processes requiring completely germ-free (aseptic) environment.

A laminar air intake system is required. The air flow velocity is 0.36-0.54 m/s.

Class "B": High-cleanliness spaces in which aseptic work processes are prepared.

Class "C": General cleanroom.

Class "D": General cleanroom with requirements lower than class "C". Similarly to CEN standards,

the classification into different classes is based on the number of particles per cubic metre of air.

GMP recommendations

In addition, GMP recommends microbiological limits in the "in operation" state, which are given in the following table.

Click on image to enlarge

IMPRESSUM

bEUlders d.o.o.

Slovenia 1360 Vrhnika Verd, Janezova cesta 2

SI73691275

8935963000

Data protection

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CONTACT

+38631650630

Slovenia 1360 Vrhnika Verd, Janezova cesta 2

info@beulders.com

IMPRESSUM

bEUlders d.o.o.

Slovenia 1360 Vrhnika Verd, Janezova cesta 2

SI73691275

8935963000

Data protection

DIVISIONS

CONTACT

Slovenia 1360 Vrhnika Verd, Janezova cesta 2