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Quality

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Manufacturing of high quality, effective, science-based and safe products complying with the Customer’s requirements is the basis of business and dynamic development of Technofilter Research-and-Manufacturing Enterprise.

Our concept of quality is focused on fulfilling the comprehensive requirements of our customers and partners by means of sustained high quality and well-timed 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 corporate culture, modern equipment and highly qualified specialists with decades of professional experience in this field.

Production according to European Standards

The new production line on manufacturing pleated membrane filter cartridges complying with European Standards with the productive capacity 50,000 pieces per year and the possibility of future expansion to 100,000 pieces per year was opened in September 2010.

Functional area of the new production facility is 1200 m2 with 400 m2 taken by clean rooms of ISO classes 7 and 8. Technofilter production facilities were designed with compliance to GMP requirements and fitted with modern equipment for operations associated with product lifecycle. Engineering systems provide working spaces with compressed treated air, sterile compressed air and highly deionized water.

The company complies with the latest safety and ecological cleanness standards and has no analogues in Russia or in the CIS. 

Space planning corresponds to the logical sequence of production operations. From the point of view of cleanness the production is divided into several zones: unclassified zones (household rooms, rooms for rest and food); so-called "gray" rooms – storage areas; industrial clean rooms of C and D classes 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 clean rooms 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, in addition special personnel gates for personnel minimize the possibility of cross contamination.

The industrial building itself 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 purchased in 2007, was originally designed for the joint production of membrane filter cartridges together with Sartorius (German Company). After purchasing the building was completely renovated and reconstructed in accordance with the developed new production project, which took into account the experience of working in the clean rooms.

In December 2012, the complex project together with Vladimir State University (State educational institution of Higher Professional Education) on the creation of high-tech production "The development of polymeric membranes with bacteriostatic, sterilizing and depyrogenizing properties, and filter cartridges and devices on its bases" 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-storyed annex to the production building with a total area of ​​1381 m2 were put into operation.

As a result of the joint research and technological work, the production of new polymeric membranes, filter cartridges and devices on their bases, with bacteriostatic, sterilizing and depyrogenizing properties for use in pharmaceutics, virology and drinking water production in extreme conditions started in 2013.

Quality and safety of products

Filter cartridges manufactured by Technofilter are produced in conformance with the worldwide quality standards and certified for application in filtration of biopharmaceutical solutions. Each filter cartridge is washed out with ultra pure water from organic and mechanic contaminations. High purity water is obtained by reverse osmosis and continuous electrodeionization of water, which is preliminarily treated using mechanical filtration, deferrization, softening, pH correction and free chlorine binding.

Technofilter’s membrane filter cartridges are subjected to 100 % integrity control and to bacterial and toxicological safety tests. In the course of testing each membrane filter is integrity tested by the non-destructive physical method of determination of rate of air passing through the water wetted membrane. Diffusion values correlate with bacteria retention test (sterilization capability test). Filtrate samples are examined for bacterial endotoxin (BE) content using the LAL test. Safety of elements is proved by a series of sanitary and chemical tests, and toxicology tests in compliance with GOST R ISO 10993.1-99, GOST R ISO 10993.5-99, GOST R ISO 10993.10-00.

Each filter is assigned with an individual number and batch number with a set of typical characteristics. These data are specified on a product label, in an individual Factory certificate and in the informational database of the enterprise. In addition, the individual number and the brand of the cartridge are recorded on the outer perforated body.    

There is a complete set of scientific and technical documentation, including all the necessary certificates. All filter cartridges manufactured by Technofilter possess Certificates of compliance with respect to safety requirements for polymeric products used in medicine, and also sanitary and epidemiological conclusions permitting their use in the food industry. Filter Capsules are added to the Register of Medical Devices of the Ministry of health of the Russian Federation.     

Quality control

The Quality Control Department of Technofilter not only maintains a high quality standard of all manufactured products but also performs research and analytical activities.

Since 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 laboratories of the Quality Control Department are equipped with modern analytical equipment, integrity testers of our own and foreign origin, testing benches. Laboratories check quality of input raw materials and final products of our own manufacture. 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

Global experience proves that implementation of a quality management system (QMS) based on the process approach is an effective tool for solution of various company tasks. One of reliable evidences of successful implementation of this system in an enterprise is the certificate of compliance with the requirements of international ISO standards of 9000 series.

In August 2016,  Technofilter successfully passed the procedure of recertification of  Quality Management System for compliance with the requirements of GOST R ISO 9001-2015 (ISO 9001: 2015) with respect to design, development and manufacturing of microfiltration membranes, filter cartridges, filter holders, filtration units and integrity testers.

The Quality Management System running on the enterprise confirms the high quality standard of products and services, beginning with the quality of statistics, control, tests  and reporting procedures, as well as the level of control of all production.


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