Design and construction of turnkey cleanrooms for medicine and pharmaceutical industries

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.

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.

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.

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.