ITEST plus s.r.o. Hradec Králové - english

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ITEST-plus s.r.o.
Founded in December 1994, ITEST-plus, s.r.o. has grown to a staff of more than 20 employees in two individual laboratories in Hradec Králové a in Bílé Vchýnice.

The manufacture and control laboratories focus on following areas:
  • production of diagnostic medical devices in vitro for microbiological laboratories
  • biological and microbiological tests of sterile and non-sterile pharmaceuticals and determination of population of microorganisms on products - medical device (bioburden)
  • microbiological validation of methods
  • monitoring and microbiological validation of cleanrooms
The manufacture laboratory and control laboratories are approved according to following documents:
  • the licence for the control laboratory by The State Institute for Drug Control (SUKL) in Prague
  • the licence for the production of veterinary medicinal products for the scope of control laboratories by Institute for State Control of Veterinary Biologicals and Medicines (ÚSKVBL) in Brno
  • EN ISO 13485:2016 certificate – Performing of biological and microbiological testing for clients producing medical devices
        Production and sale of diagnostic devices in vitro for mikrobiology (by LRQA)
  • the Good Manufacturing Practice compliance of a Manufacturer (GMP) for human investigational medicinal products and for human medicinal products by The State Institute for Drug Control (SUKL) in Prague
  • the Certificate of Accreditation on ČSN EN ISO/IEC 17025: 2018 Performance of microbiological and biological tests of medical devices, performance and evaluation of microbiological monitoring of clean environments, including sampling to the extent as specified in the Appendix by Czech Accreditation Institute (CAI)
Nowadays we produce more than 40 kinds of diagnostic medical devices in vitro (IVDs) which serve in microbiological laboratories for both human and veterinary purposes to identify the inflictor of infectious disorders efficiently and quickly.
Some of our products can also be used in laboratories specialized on food microbiology. Diagnostic devices are designed for serological identification (e.g. latex agglutination sets, antiserum for slide agglutination.) Diagnostic and antifungal discs are the major part of the production.

In terms of biological and microbiological tests, the control laboratory carries out following tests for manufacturers of pharmaceuticals of human medicinal products, human investigational medicinal products, veterinary medicinal products and medical devices in accordance with Czech Pharmacopoeia, Ph.Eur, eventually according to USP and related ISO standards.
  • the test for sterility,
  • microbial assay of antibiotics,
  • tests for endotoxins – gel-clot method, kinetic turbidimetric method,
  • microbiological testing on non-sterile products: enumeration of microorganisms,  the test for specified microorganisms,
  • testing of microbiological quality of purified water, highly purified water and water for injections
  • determination of population of microorganisms on products - medical device (bioburden)
  • efficacy of antimicrobial preservatives in pharmaceuticals
  • testing of bactericidal, fungicidal, and yeasticidal efficacy of antiseptic pharmaceuticals
Testing methods listed above on medical devices are also accredited according to CSN EN ISO/IEC 17025 by Czech Accreditation Institute (CAI) and marked by italics.

We also carry out monitoring of microbiological contamination in cleanrooms, e.g. air, surfaces and personnel. We perform both active and passive air monitoring by aeroscope and settle plates, finger prints, surface prints on contact plates and swabs from surfaces.

 The Quality Policy in Manufacture and Control laboratories ITEST plus, s.r.o. is based on the effort of all our employees to meet the customer requirements through supplying high quality and safe products and services assuring quality, objectivity and consistency of laboratory procedures in a timely manner.

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