3D tour of cleanliness zones of class D, C

You can virtually visit the sterile areas that we recently commissioned, which involve complex supply of construction and technological systems with high You can virtually visit the sterile areas that we recently commissioned, which involve complex supply of construction and technological systems with high requirements for the purity of technological media. These areas include laminar zones spanning 150 sq.m., where we have installed laminar flow hoods that meet stringent criteria for air quality, temperature, and humidity parameters.


Clean rooms for OPERATING UNITS

Operating theaters in hospitals are among the most sensitive environments in healthcare institutions. Hospitals with state-of-the-art clean room technology such as seamless walls, floors and ceilings, these operating rooms are equipped to cleanliness standards to minimize airborne pathogenic flora and maintain a sterile environment.


Clean rooms for PHARMACEUTICAL PRODUCTIONS

SVS-ARTA (Ukraine, Cherkassy) is a leading supplier of integrated EPC solutions for aseptic zone projects in Ukraine, specializing in pharmaceutical engineering and pharmaceutical equipment. With extensive experience in designing cleanrooms for pharmaceutical factories in Ukraine, optimizing processes, manufacturing equipment, and conducting installation and commissioning, we are dedicated to delivering tailored and optimal solutions for the pharmaceutical and medical industry.

Clean rooms for hospitals and pharmaceutical LABORATORIES

The accuracy of laboratory research much depends on the conditions of carry out. Engineering company SVS-ARTA is engaged in the design and construction of clean rooms for pharmaceutical laboratories and hospitals in Ukraine. They allow you to achieve perfectly accurate cleanliness control results without distorting the readings.

CLEANLINESS CLASSES – requirements for pharmaceutical premises

The ISO classification is based on international standards that govern the acceptable levels of cleanliness at each level of the room. International Organization for Standardization SO 14644-1 provides guidance on acceptable air quality levels in specific ISO classes for clean rooms.

CLEAN ROOMS for medicine GMP / ISO

The scope of application of clean zones is increasing every year. The pharmaceutical, food and chemical industries cannot do without clean zones. Clean area standards according to GMP / ISO / DSTU are adhered to by the majority of medical institutions.

Medical cleanrooms are vital for the work of finding medical solutions, developing vaccines and treatments through pharmacological products, and manufacturing life-saving medical devices, among other important applications. Three main types of medical cleanrooms are medical research cleanrooms, medical device cleanrooms, and pharmaceutical cleanrooms.

Working in cleanrooms?

Design and construction of turnkey cleanrooms for medicine and pharmaceutical industries

SVS-ARTA is a Ukrainian engineering company, a developer of pharmaceutical plants and a provider of EPC solutions (Engineering, Procurement, and Construction)

валидация и сертификация gmp

Validation and qualifications

Sterile areas are validated and then certified according to the selected ISO 14644-1 class. Each ISO14544-1 class has its own unique requirements that must be presented to qualify an object for the specified classification. We carry out all the necessary validation and certification operations.

3д чистых помещений

3D laser scanning

Engineering company SVS-ARTA offers 3D laser scanning services for premises and architectural objects. We will be able to come to you with our equipment and software using high quality portable laser scanners. Our experienced staff will quickly digitize walls, windows, ceilings, floors and others to work on your project to meet your goals.

производство
Собственное производство

Own production

The company “SVS-ARTA” owns its own production complex, where future clean walls (wall panels), cassette and panel ceilings, hermetic medical doors for clean rooms, as well as other necessary pharmaceutical equipment are manufactured. All finishing and production processes of the clean rooms are controlled by an ISO 9001 certified quality management system.

строительство и монтаж чистых помещений

Construction and installation

An experienced, professional team of engineers, installers and workers of SVS-ARTA, for more than 15 years, has been successfully designing, installing and building turnkey clean rooms in Ukraine. No matter when your project is completed, we will provide continuous service for operation, maintenance, repair, spare parts supply, improvement and renovation.

  • What is a cleanroom?
  • Advantages of cleanrooms
  • Cleanliness classes ISO / GMP
  • How to create a clean room
What is a cleanroom?

A clean room is a room or space in which the level of particulate contamination is controlled within specified levels. Air composition, temperature, humidity, air flow patterns and pressures are controlled to minimize the entry, formation and retention of particles (e.g. dust) inside the room. These rooms are commonly used in R&D, medical, pharmaceutical and high-tech industries where product quality and employee well-being are critical.

Sterile areas GMP / ISO,  are a combination of engineering design, fabrication, finishing and operational controls required to transform a “normal” room into a “cleanroom”.

Essentially, sterile areas are intended to remove contaminants, particles, and conventional pollutants from the outside ambient air. Open air is first directed to the filtration system. Filters (HEPA or ULPA) then purify and decontaminate this air according to their specifications. After that, the filtered air is blown into the cleanroom. In addition, the polluted air in the clean area is displaced by registers outside the room or returned back to the filters, and the process is resumed.

In the pharmaceutical sense, aseptic rooms are those ones that comply with the GMP / ISO / DSTU code of requirements.

Advantages of cleanrooms

Controlled cleanliness is a prerequisite for the production of high-tech sterile products that minimize the likelihood of contamination by foreign particles.

The advantage of industrial cleanrooms is that their use will return the investment capital by improving product quality and yield. The level of cleanliness of the premises required for the production of manufactured products is determined by the requirements for the products.

Improved cleanrooms operation mode open extremely profitable business opportunities that eventually contribute to long-term customer loyalty. An indication of this is the fact that all major players in the medical, pharmaceutical and semiconductor industries are using cleanroom technology. As innovation and development continues to grow, the market for aseptic room technology in Ukraine will continue to expand, making it a must in all industries.

Cleanliness classes ISO / GMP

CLEAN ROOM CLASSIFICATIONS

Clean rooms are classified according to the cleanliness level of the air inside the controlled environment. The clean room class is the level of cleanliness the room complies with, according to the quantity and size of particles per cubic meters of air. The primary authority in the US and Canada is the ISO classification system ISO 14644-1.

This ISO standard includes these clean room classes : ISO 1, ISO 2, ISO 3, ISO 4, ISO 5, ISO 6, ISO 7, ISO 8 and ISO 9.

ISO 1 is the “cleanest” class and ISO 9 is the “dirtiest” class. Even if it’s classified as the “dirtiest” class, the ISO 9 clean room environment is cleaner than a regular room.

The most common ISO clean room classes are ISO 7 and ISO 8.

The main purpose of this standard is to establish the air cleanliness class depending on the concentration of suspended particles in medical rooms and aseptic areas. ISO covers issues such as design, testing, exploitation and biological contamination. 9 classes are offered, each with a certain level of particle concentration. For example, in a completely clean room without equipment, the cleanliness class will be higher than with operating equipment. Accordingly, the concentration of particles will be lower.

For clean rooms of pharmaceutical production in Ukraine, there are other standards developed by the European Union and the United States – GMP. So what’s the difference? For example, a person buys household appliances, its quality can be determined independently, but how to determine the quality of pills? This was the impetus for the emergence of a new quality standard – GMP. It is GMP that sets strict requirements: what can and cannot be done by enterprises that manufacture pharmaceutical products.

And if ISO standards are interpreted as voluntary, and the company is not a government organization, then no enterprise in the medical industry can operate without GMP standards. There are 4 classes of air pollution for the production of medical products.

So, we conclude: both GMP and ISO qualitatively complete each other, especially in the pharmaceutical industry, there are no contradictions between these standards.

How to create a clean room

Follow this process with one trusted partner to create the optimal turnkey cleanroom.

  •  Conceptual design. The first step in the process of developing a durable solution is to analyze your future requirements to create a general system project. Process experience in the conceptual design process forms the basis for the follow stages of cleanroom construction.
  •  Basic and detailed design: during the design stage, your requirements are refined and you receive a fixed price quote, schedule and alignment of project requirements.
  •  Turnkey cleanroom installation: ss your partner, we provide complete installation and ensure that all functional and system requirements for your cleanroom are documented and met.
  •  Qualification and validation process: system and equipment qualification is an important part of the validation process and is governed by the EU GMP guidelines. In the case of GMP projects, SVS-ARTA can take responsibility for the final design, installation, function and results.

Completed projects «SVS-ARTA»

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Industry directions of the company

SVS-ARTA develops and implements clean rooms for various industries and institutions


40%

Pharmaceutical production

For a number of drugs (injections, vaccines, some types of ointments and solid forms), need sterility space, aseptic production.

25%

Technological laboratories

Clean zones are designed to protect raw materials, intermediate and final products from airborne contaminants from the environment.

20%

Medical institutions

In medical institutions, clean rooms are necessary in the operating room, reanimations and maternity wards, special purpose wards (allergology, or hematology oncology).

15%

Food industry

In the food industry, decisions usually had to be made on clean rooms with a full stainless steel frame combined with a rigid wall or program screens.

Customer Reviews

Feedback from customers of the company “SVS-ARTA” after the delivery of objects

The operating room you want to work in!

I just want to thank you and your team for doing such a great job and supporting us during our difficult times. Great job!

Vitaly Grigoriev
traumatologist of the 3rd city hospital of Cherkasy

Excellent, I recommend!

Excellent, I recommend! High quality and reliable!

Bogdan Larin
Head of the Department of Pharmacy "Hemoteka"

Thank you very much!

Many thanks to the SVS-ARTA team for cooperation and quality service. Clean systems from SVS-ARTA are engineering installations of the European level.

Nikolay Fischuk
Pharmaceutical quality control manager

27 important awards

For many years of successful and productive work, the company has received many awards: “Leader of the branch”, “Leader of the year 2017”, “Industry leader 2017”, “Quality star 2018”

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Our partners

Companies with whom we design and build turnkey cleanrooms

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Why choose us?

Our advantages and strengths


Own manufacturing bases

80% of the cleanroom project products are manufactured directly by our manufacturing facilities.
This significantly affects the delivery time and pricing policy.

We get work finished on time

We carry out projects on time
Our team will complete all your projects on time and within budget.
You can be sure of this with our company.

Always in touch and available

We are there for you whenever you need us. Contact us for a consultation, a quote or any question you may have about your project or our work. We’re here every step of the way.

Professionally and responsibly

You can always rely on SVS-ARTA. Our team of professionals will help you quickly turn your dream production or factory into reality

Publications

Articles about new products and industry events


Qualification of rooms

Qualification of rooms

31.08.2022

Basic requirements for clean rooms in pharmaceutical production Cleanroom requirements for aseptic pharmaceutical and terminally sterilized pharmaceuticals differ. The filling / filling process (critical process) in the production of non-terminally sterilized pharmaceuticals requires a clean area “A” surrounded by a clean area of class “B” to minimize the risk of contamination of the finished product […]

Clean rooms for medicine

Clean rooms for medicine

31.08.2022

MEDICAL CLEANROOMS Medical cleanrooms are vital for the work of finding medical solutions, developing vaccines and treatments through pharmacological products, and manufacturing life-saving medical devices. Three main types of medical cleanrooms are medical research cleanrooms, medical device cleanrooms, and pharmaceutical cleanrooms. The cleanroom design for each type will differ depending on the goals of the […]

Contact us

You can visit us or write at any time. We will consider all your wishes.

Contact us at a convenient time

By e-mail, by phone or just visit us at any time.


Phones

+38(096) 255-55-25, +38(096) 255-55-22, +38(095) 562-20-69

Location

Geronimovskaya st., 1/5, Cherkassy, Ukraine,

Email

svsarta@gmail.com

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    Engineering company "SVS-ARTA" specializes in the construction and installation of cleanrooms.