“Clean room is a room where the air are kept in a certain range of predetermined size and number per cubic meter of particles such as dust, microorganisms, particulate matter and chemical vapors. If other parameters may be monitored therein as necessary, e.g., humidity, pressure and temperature. Such facilities are generally constructed and used so as to minimize the introduction, generation and accumulation of particles inside the room. “That is the definition of purity gives us Wikipedia.
The first requirement, which began to show the purity of any premises in medicine in 1860. It has been observed that, when the room is clean, it significantly reduces the number of infectious complications after surgery. It was a breakthrough in medicine, but eventually the concept of purity space formed after the development of the room ventilation system. Room ventilation, namely removal of dirty air and the influx of pure, cemented standards of cleanliness.
After the medical standards have been extended to other areas. It has been observed that in a clean and comfortable room performance levels increased, decreased fatigue and staff illness. Also cleanliness in the environment must also be ensured optimal lighting, comfortable temperature and humidity, air-conditioning, consistent with the parameters of the process.
With the development of technical progress, and increased requirements for clean air, which were determined by the accuracy and cleanliness in medical institutions, chip manufacturing, medical preparations become necessary to measure the purity and structure parameters. Which eventually resulted in the standards that have become mandatory in these facilities.
What are the standards of cleanliness today and what are the requirements for purity are presented in various enterprises.
In 1947 it was founded the best-known non-governmental organization for Standardization ISO. At the time of founding of the organization it included only 25 countries. At present, the organization includes 165 countries and has published 22654 international standards to ensure compatibility of production processes and technologies.
ISO standards are now unified mechanism for assessment of the quality of production and management in the world community. They are used in all traditional industries, ranging from agriculture and construction, the production of household goods and complex medical devices, to the newest areas of information technology.
The need to develop ISO standards dictated by the market. They promote business progress, the development of the consumer sector and the economy as a whole.
ISO certification of the passage is not compulsory and is conducted only at the request of the business owner. In spite of this, more and more enterprises in Ukraine are implementing the ISO standard.
This is dictated by various factors: – a competitive advantage;
– the requirements of the market of consumers;
-the presence of ISO certificate is required for participation in public procurement, tenders, etc .;
– the availability of ISO certification can increase the price of the products supplied;
– foreign partners is much more profitable to work with companies that have ISO certification;
It is because of its extreme versatility, ISO 9001 certification is gaining more and more Ukrainian companies.
The introduction of ISO standards is crucial for those companies and organizations that seek to:
– improve the quality of products or services;
– improve their safety;
– improve the management system;
– improve the efficiency of production;
– systematize the management of the enterprise;
– increase the competitiveness of products;
– to simplify the licensing process;
– be able to participate in international projects;
– to attract foreign investors.
In Ukraine, the purity requirements governed by standard ISO 14644 “Cleanrooms and associated environment”, which includes:
|Document Number||Short title|
|ISO 14644-1||Classification of air cleanliness in the room|
|ISO 14644-2||Check clean rooms for a long compliance with the ISO 14644-1 standard|
|ISO 14644-3||Metrology and test methods|
|ISO 14644-4||Design, construction and start-up|
|ISO 14644-6||The concepts and definitions|
The ISO 14644 standard, there are 9 class of clean air.
|class ISO||Limits of maximal concentration (particles / m3 air) particle size of equal to and greater below, micron||Application area|
|ISO 3||1000||237||102||35||eight||0||Only the production of integrated circuits with submicron geometry.|
|ISO 4||10000||2370||1020||352||83||0||Manufacture of integrated circuits with the distance between the conductors less than 2 microns.|
|ISO 5||100000||23700||10200||3520||832||29||Aseptic manufacturing of injectable preparations, requiring absence of microorganisms and particles. Surgical operations for implantation and transplantation of organs. Isolation of patients with immune deficiency, including after bone marrow transplantation.|
|ISO 6||1000000||237 000||102000||35200||8320||293||Production of high grade optical elements. The assembly of miniature bearings.|
|ISO 7||–||–||–||352000||83200||2930||Assembling precision hydraulic and pneumatic equipment, with the servo valve, high-precision clock mechanisms, high quality transmissions.|
|ISO 8||–||–||–||3520000||832000||29300||Optical manufacturing, electronic component assembly, assembly of hydraulic and pneumatic devices.|
|ISO 9||–||–||–||35200000||8320000||293000||Auxiliary facilities, warehouses, precision equipment, changing rooms.|
There are separate standards governing food safety.
The main principles of food safety are presented in the system of HACCP (HACCP – Hazard Analysis and Critical Control Points), which translates as “hazard analysis and critical control points” and is the most effective tool of preventive food safety at the enterprise level.
HACCP – is one of the parts of ISO 22000.
It involves hazard analysis critical control points. This process determines that it can threaten food security – the sources of bacteria or chemical contamination, for example. Critical control points are points of the production or handling of food products, in which they cease to be a danger and potential threats become reality. HACCP system directly concerns these dangers and establishes procedures to monitor the changing of critical control points, such as the correct storage temperature or level of purity. HACCP also includes keeping accurate records and check for regular monitoring procedures at the plant.
ISO 22000 and HACCP – is food safety standards can implement any company involved in the production or processing of food. Companies often introduce them at the same time, and list them separated by a comma, sometimes as identical or very related concepts. The difference lies in the fact that HACCP – is a specific process for monitoring potential hazards that can be used both independently and as part of the ISO 22000, which is a broader safety management system of food, based on the principles of quality.
Principles for determining air cleanliness standards is identical for all – is considered to be the amount of pollutants in one cubic meter of air. Depending on the amount and size of dust particles in the air of the room can be divided by class cleanliness of the premises, such division exists in all existing standards.
The main task of a cleaning company, which provides services in the enterprise – it is aware of the requirements that must be followed on the basis of ISO standards, and adhere to the rules adopted in the framework of the Implementation of HACCP in enterprises related to food technology.
By means of cleaning techniques to achieve purity that is optimal and comfortable. Know and apply the chemistry, that will not bring harm to others.
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