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Clean room

Cleanrooms are a prerequisite for the development and production of specific and demanding products in industries such as semiconductors, batteries, pharmaceuticals, nanotechnology, various laboratory environments, and other processes with strict hygiene and environmental control requirements.

What are cleanrooms?

A cleanroom is an environment with a low concentration of contaminants such as dust, aerosol and chemical vapors. It is specifically designed to prevent external contamination, and continuously remove particles, microorganisms, and pollutants from the air using air conditioning systems. A mandatory component of every cleanroom is air filtration using absolute filters (HEPA and ULPA), which ensure the highest level of air filtration. Additionally, specialized equipment, materials, and clothing are used to prevent contamination from external sources. All procedures within cleanrooms are clearly defined and standardized, and the access is strictly controlled. These environments are designed and built in accordance with standards such as ISO 14644-1, and with GMP guidelines.

Our approach to cleanroom design and implementation

Our approach to cleanroom design and construction meets the specific requirements of each industry, whether it is a high-profit industry or the one with somewhat lower demands. We begin with an analysis of the existing infrastructure and the client’s needs, then we make the project technical documentation in accordance with current regulations, and build cleanrooms which meet the specific requirements. We pay close attention to the air quality and controlled flow of personnel and materials. Our team offers turnkey solutions, including equipment installation, system integration and validation — all in compliance with the highest industry standards.

Application of clean rooms for industrial production

Pharmaceutical Industry

Cleanrooms are essential to ensure product sterility and prevent microbiological or particulate contamination during production, as well as to protect the environment from potentially hazardous substances.

Laboratories

Microbiological, chemical, and research laboratories use cleanrooms for precise testing that requires strict control of environmental parameters.

Automotive Industry

In the production of modern sensors, lithium batteries, electronic components, and optical systems, cleanrooms are used to maintain strict air quality control to ensure product quality and reliability.

Food Industry

In the production of baby food, supplements, and other food products, clean zones are primarily used to meet microbiological requirements.

Optical Industry

Cleanrooms in the optical industry allow for air purity control, removing dust and microparticles that can affect lens quality, while stable temperature, humidity, and air pressure ensure product precision and long lifetime.

Operation theatres

Cleanroom technology in operating rooms plays a key role in preventing infections and maintaining a sterile environment during surgical procedures. Advanced air filtration systems eliminate microorganisms and pollutants, while adequate air distribution prevents the spread of contamination between different zones.

CLEAN ROOMS - our works

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Cleanroom standards

Cleanrooms are controlled environments where the level of contamination is defined by the number of particles per cubic meter of a specific size. A typical urban environment contains approximately 35,000,000 particles per cubic meter of air sized 0.5 µm or larger, corresponding to ISO Class 9. In contrast, an ISO Class 1 cleanroom allows zero particles in this size range and up to 12 particles per cubic meter smaller than 0.3 µm.

In the pharmaceutical industry, cleanrooms play a crucial role in the production of ingredients and products that must be protected from microbiological or any other contamination. These rooms are typically equipped with HEPA and, where necessary, ULPA filters, as well as air dehumidifiers.

Cleanrooms are classified according to the number of contaminant particles they contain per cubic meter of volume.

ISO 14644-1 standard for cleanrooms

EU GMP classification

Class	Maximum particles per cubic meter						FED STD 209E equivalent
Class	≥ 0.1 µm	≥ 0.2 µm	≥ 0.3 µm	≥ 0.5 µm	≥ 1.0 µm	≥ 5.0 µm	FED STD 209E equivalent
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	3520	832	29	class 100
ISO 6	1.0 x 106	237 000	102 000	35 200	8 320	293	class 1 000
ISO 7	1.0 x 107	2.37 x 106	1 020 000	352 000	83 200	2 930	class 10 000
ISO 8	1.0 x 108	2.37 x 107	1.02 107	3 520 000	832 000	29 300	class 100 000
ISO 9	1.0 x 109	2.37 x 108	1.02 x 108	35 200 000	8 320 000	293 000	room air

EU GMP guidelines are more stringent than others, requiring cleanrooms to meet particle counts at operation (during manufacturing process) and at rest (when manufacturing process is not carried out, but room AHU is on):

Class	Maximum particles per cubic meter
	At rest	At rest	In Operation	In Operation
	0.5 µm	5 µm	0.5 µm	5 µm
grade A	3 520	20	3 520	20
grade B	3 520	29	35 200	2.93
grade C	352 000	2 930	3 500 000	29.30
grade D	3 520 000	29 300	not defined	not defined

What affects the cleanliness of a clean room?

Materials

Clean rooms are built from materials that are easy to clean and do not retain dirt – most often clean room panels covered on both sides with metal sheets and filled with rock wool.

Design

Keeping a clean room class depends on a carefully planned layout of zones (including gray zones), air handling and distribution systems, technical equipment, as well as all technical connectors that are aligned with the requirements of the specific process.

Equipment and furniture

Equipment and furniture used in clean rooms must have as low as possible contribution to the air contamination and must be made of special materials that are easy to clean – most often stainless steel.

HVAC system

A system with an adequate number of air changes and adequate air quality.

Air pressure

Balanced overpressure and underpressure depending on the configuration of the production process, in order to avoid cross contamination.

Personnel

The way personnel enter the clean room and special wardrobe that is worn inside the clean room.

Cleaning procedures

An appropriate cleaning procedure that must be followed according to strictly defined rules.

Disinfectants

Using special disinfectants intended for maintaining a clean room.

Frequently asked questions about
clean rooms

What is the primary function of a cleanroom?

The purpose of a cleanroom is to eliminate particles, microorganisms, and contaminants from the air to ensure a sterile and controlled working environment.

How are cleanrooms classified?

Cleanrooms are classified according to the ISO 14644-1 standard, with classes ranging from ISO 1 (the highest level of cleanliness) to ISO 9 (the least strict cleanliness control).

Can an existing space be adapted into a cleanroom?

Yes. Our team offers audits of existing spaces and develops design solutions for adaptation in accordance with the required standards.

Is it possible to expand cleanrooms later?

Yes, it is possible to expand cleanrooms, but this requires careful planning, aligning with existing systems and standards, as well as conducting necessary validations and certifications to ensure continuity in maintaining required parameters.

What materials are used for walls and ceilings in cleanrooms?

Walls and ceilings are made of panels with smooth, easily washable surfaces that prevent particle retention.

What materials are used for floors in cleanrooms?

Floors are most commonly made of epoxy coatings or PVC coverings that allow for easy cleaning and resistance to chemicals and wear.

How long does it take to prepare a quote?

Time required to make a quote depends largely on the availability of input data and the scope of work. Altera is available to its current and future clients in the shortest possible time.

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