Philosophy of Quality
Production of high-end, high-quality and safe products in accordance with consumers’ requirements is the basis of operation and dynamic development of TECHNOFILTER Research-and-Manufacturing Enterprise.
TECHNOFILTER’s philosophy of quality is aimed at comprehensive satisfaction of consumers’ requirements by ensuring high quality of products and on-time deliveries at competitive prices.
Production of high-end and safe products capable of doing responsible assignments in critical applications is impossible without high general manufacturing culture, modern equipment and highly qualified specialists having a long-term professional experience in the industry.
A new European-level manufacturing plant
In September 2010, a new plant for manufacturing of membrane pleated filter elements having the production rate of 50,000 pcs/year that can further be increased to 100,000 pcs/year was launched at the enterprise. The plant fully complies with modern European standards.
The working area of the new plant is 1,200 m2, whereof 400 m2 are occupied by clean rooms of ISO 8 and ISO 7 classes. The plant has air conditioning and ventilation systems, air and water treatment areas, storage facilities and analytical laboratories. The lay-out of rooms is in conformance with the logical sequence of manufacturing operations.
In terms of purity requirements, the plant is divided into several zones: unclassified rooms (amenity rooms, lounges and canteens); the so-called “grey” rooms (storage rooms); and manufacturing clean rooms of C and D classes in accordance with requirements of GOST and GMP (European Union guidelines on Good Manufacturing Practice).
In unclassified rooms, microbiological purity and aerosol composition is not monitored, but the personnel is working in special clothes. In clean rooms, strict requirements on sanitary-hygienic, microbiological and aerosol control are observed. The air treatment and supply system automatically regulates air parameters.
Special attention is paid to the issues of hygiene, rules of access and behaviour of the personnel in manufacturing areas. The personnel is provided with kits of work clothing in conformance with clean room requirements. To transport materials and products from one room to another, special transfer chambers are used. Special sanitary inspection rooms for the personnel minimize the possibility of cross-contamination.
The building in which the new plant is located is completely self-contained, it has its own heating and air conditioning system. The office and manufacturing building having the total area of 3,000 m2, that was purchased by Technofilter in 2007, was originally designed for manufacturing of membrane filter elements by a Soviet-German joint venture (in association with Sartorius). After the purchase the building was completely repaired and renovated in accordance with the plan of the new plant, taking into account the experience of manufacturing in clean rooms that was gained at a former site.
The manufacturing areas of the plant were prepared in accordance with GMP requirements and provided with modern equipment for accomplishment of operations related to the life cycle of products. The enterprise complies with the most recent safety and environmental purity standards.
Product quality and safety
Technofilter’s filter elements are produced in accordance with technical specifications for product quality and are certified for use in filtration of biopharmaceutical solutions. All filter elements are washed with high-purity water to remove organic and mechanical contaminants. The high-purity water is produced by reverse osmosis and continuous electrodeionization of water which has been previously prepared using the processes of mechanical filtration, deironing, softening, pH correction and free chlorine binding.
Technofilter’s membrane filter elements are 100% integrity tested and undergo tests for bacterial and toxicological safety. In these tests, each membrane filter is checked for integrity by a non-destructive physical method which involves determination of the gas flow rate through the water-wetted membrane. The diffusion results are correlated with results of the bacteria retention test (test of sterilizing capacity). Samples of the filtrate are checked for the presence of bacterial endotoxin (BE) by using the LAL test. Safety of elements is guaranteed by a series of sanitary-chemical and toxicological tests performed 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 its individual number and lot number along with a set of representative characteristics. These data are included into the label and factory certificate of the product as well as Technofilter’s information database. In addition, the number and grade are specified on the outer perforated housing of the element.
We have a complete set of scientific and engineering documentation, including all necessary certificates. Technofilter’s filter elements have certificates of conformance to safety requirements for polymer products used in medicine as well as sanitary-epidemiological certificates authorizing their use in food industry.
Capsule filter elements are included into the Public Register of medical appliances of the Health Ministry of the Russian Federation.
Technofilter’s Quality Control Department is responsible for maintaining high product quality and is also engaged in research and analytical activities. Since we develop our products on our own, we design and monitor all stages of the manufacturing process, from development to checking of all serial products.
All laboratories of the QCD are provided with modern analytical equipment, integrity control instruments made in Russia or abroad and testing stands. Supply systems provide the laboratories with conditioned venting air, sterile compressed air and highly deionized water. The laboratories are engaged in checking the quality of incoming raw materials and finished products made by Technofilter as well as competitive products. In addition, QCD specialists are also involved in assessing filterability of various fluids.
Quality Management System
The world experience shows that an effective tool in achieving many goals of a company is introduction of a quality management system based on the process approach. One of the most convincing proofs that such a system was successfully applied at the enterprise is the certificate of conformance to requirements of ISO 9000 series international standards.
In July 2010, Technofilter successfully passed the procedure of recertification of the Quality Management System for conformance to requirements of ISO 9001:2008 with regard to design, development and production of microfiltration membranes and cartridge filter elements. This is already the third certificate issued to Technofilter (the Quality Management System was developed and introduced at the enterprise in 2004). The Quality Management System being used ensures a high quality of products and services, from quality of statistics and accounts to control and tests as well as a high control level of all production processes and consumer-related processes.
The operation of the enterprise is coordinated by the Quality Management Department in accordance with the Quality Management System. The products being produced are subjected to thorough control at all intermediate production stages in accordance with technical documentation on the basis of the Quality Management System. All procedures needed for ensuring quality of products and services are stated in specific documents of the Quality Management System. Strict observance of all rules and requirements of regulatory documents guarantees production of high-quality products capable of doing responsible assignments in critical applications.
Scientific and technical support
Each process has its own unique requirements. Our application specialists and process engineers work out each stage and make sure the operation of the stages is well coordinated and monitored. Technofilter staff will assist you in scientific aspects of filtration and will instruct you how to find the optimum combination of filters and other components of the system in accordance with specific requirements of the application.
We can carry out filterability evaluation tests to facilitate the selection and optimization of the filtration process. The tests can be carried out either in our laboratories or on site.
Range of services
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