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Quality

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The production of knowledge-intensive, efficient, high-quality and  safe products that meet the requirements of Consumers is the basis for the vital activity and dynamic development of the scientific and industrial enterprise TECHNOFILTER.

 

The quality philosophy of  "TECHNOFILTR" LLC is focused on satisfying the comprehensive requirements of our customers due to the high quality of the products offered and timely deliveries at competitive prices.

 

The production of knowledge-intensive and safe products, which are entrusted with responsible tasks in critical applications, is impossible without a common high culture of production, modern equipment and the availability of highly qualified specialists with many years of professional experience in this field.

 

Production of European level

 

In September 2010. the enterprise opened a new production of membrane corrugated filter elements with a capacity of 50 thousand units. a year with the possibility of further increasing the capacity to 100 thousand units. a year that fully complies with modern European standards.

 

The functional area of the new production is 1200 m2, of which 400 m2 are clean rooms of ISO class 8 and ISO 7. The production areas of "Technofilter" are prepared in accordance with GMP and equipped with modern technological and testing equipment for operations related to the life cycle of products. The installed engineering systems provide production with prepared ventilation air, sterile compressed air and highly de-ionized water.

 

The company meets the latest safety and environmental standards and has no analogues in its industry in Russia and the CIS.

 

 

The layout of the premises corresponds to the logical sequence of production operations. By its purity the production is divided into several zones: unclassified premises (household rooms, rooms for rest and food); so-called "gray" premises - warehouse; industrial clean rooms of classes C and D according to the requirements of GOST and GMP (European Union Good Manufacturing Practice).

 

In unclassified rooms, microbiological cleanliness and aerosol composition are not monitored, but the staff works in special clothing. In cleanrooms, strict requirements for sanitary, hygienic, microbiological and aerosol control are observed. The air preparation and supply system regulates the air parameters in the automatic mode.

 

Particular attention is paid to hygiene issues, access rules and personnel behavior in production areas. The personnel is provided with sets of technological clothing in accordance with the regulatory requirements for emergency situations. To transfer materials and products from one room to another, special transfer chambers are used, special personnel gates for personnel minimize the possibility of cross contamination.

 

The building itself, where the new production works, is completely autonomous, has its own heating and air conditioning system. The administrative and production building with a total area of ​​3000 m2, which the company acquired in 2007, was originally designed for the production of membrane filter elements by a joint Soviet-German company with Sartorius. After the acquisition, the building was completely repaired and reconstructed in accordance with the developed new production project, which took into account the experience in the clean zones, obtained earlier in the previous production.

 

In December 2012, the complex project on the creation of high-tech production, performed with the participation of the Russian higher educational institution (GOU VPO Vladimir State University), "Development of polymer membranes with bacteriostatic, sterilizing and depyrogenizing properties, filter elements and devices based on them" was successfully completed.

 

The reconstruction of existing production and administrative buildings was carried out. In February 2013, the superstructure of the 4th floor of the administrative building and the 4-storey extension to the production building with a total area of ​​1381 sq.m. were put into operation.

 

 

As a result of the joint research, development and technological work carried out in 2013, the production of new polymer membranes, filter elements and devices based on them, with bacteriostatic, sterilizing and depyrogenizing properties for use in pharmaceutics, virology and drinking water production in extreme conditions.

 

Quality and safety of products

 

Filter elements "Technofilter" are produced in accordance with regulatory and technical documents for product quality and are certified for use in filtration processes of biopharmaceutical solutions. All filter elements are washed from organic and mechanical impurities with highly purified water. High purity water is obtained by reverse osmosis and continuous electrodeionization of water, which is preliminarily prepared using mechanical filtration, deferrization, softening, pH correction and free chlorine binding.

 

Membrane filter elements "Technofilter" are subjected to 100% integrity control and are tested for bacterial and toxicological safety. During the tests, each membrane filter is tested for integrity by a non-destructive physical method to determine the flow rate of the gas through a water-wet membrane. The diffusion rates are correlated with the bacteria retention test (sterilization test). The filtrate samples are checked for bacterial endotoxin (BE) with the LAL test. The safety of the elements is established by a series of sanitary-chemical and toxic tests carried out in accordance with GOST R ISO 10993.1-99, GOST R ISO 10993.5-99, GOST R ISO 10993.10-00.

 

Each filter element is assigned an individual number and batch number with a set of typical characteristics. These data are recorded on the product label, in the individual passport for the product, as well as in the company's information database. In addition, the number and brand is applied to the outer perforated body of the element.

 

For all products we have a complete set of scientific and technical documentation, including all the necessary certificates. Filtering elements of the NPP "Technofilter" have certificates of compliance with safety requirements for polymeric products used in medicine, as well as sanitary and epidemiological conclusions permitting their use in the food industry. Filter elements of the capsular type are included in the State Register of Medical Devices of the Ministry of Health of the Russian Federation.

 

Quality control

 

The Quality Control Department functions at the enterprise, which is engaged in both maintaining a high level of quality of all manufactured products, as well as with research and analytical activities.

 

As we develop our products ourselves, we design and control all stages of the production process - from the idea of ​​creating to the control of all serial products.

 

All OKK laboratories are equipped with modern analytical equipment, instruments for monitoring the integrity of own and imported production, test benches. The laboratories are engaged both in testing the quality of input raw materials and finished products of own production, and in studying similar products, in addition, the specialists of the department conduct work on the evaluation of the filterability of various media in order to select the optimal filtration systems.

 

Quality Management System

 

World experience proves that an effective tool for solving many tasks of the company is the introduction of a Quality Management System based on a process approach. One of the most authoritative evidence of successful implementation of such a system in the enterprise is the certificate of compliance with the requirements of the international standard ISO 9001 series.

 

In August 2016,  Technofilter successfully passed the procedure of recertification of HYPERLINK "http://technofilter.ru/about/management_of_quality/" Quality Management Systems for compliance with the requirements of GOST R ISO 9001-2015 (ISO 9001: 2015) for the design, development and production of microfiltration membranes, filter elements, filter holders, filtration plants and integrity monitoring devices.

 

The Quality Management System operating at the enterprise ensures a high level of quality of products and services, from the quality of statistics and reporting to control and testing, as well as the level of control of all production processes and processes associated with the Consumer.


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