Founded in December 1994, ITEST-plus Ltd. has grown to a staff of more than 20 employees in two individual laboratories.
The company focuses on three main areas:
production of diagnostic medical devices in vitro for microbiological laboratories
biological and microbiological tests sterile and non-sterile preparation and bioburden
microbiological validation and monitoring of clean rooms
All activities are performed according to:
the licence for the control laboratory by The State Institute for Drug Control (SUKL) in Prague
EN ISO 13485:2016 certificate – Productionand Sale of diagnostic devices in vitro for microbiology
EN ISO 13485:2016 certificate – Performing of biological and microbiological testing for clients producing medical device
the Good Manufacturing Practice compliance of a Manufacturer (GMP) certificates by The State Institute for Drug Control in Prague
the Certificate of Accreditation on ČSN EN ISO/IEC 17025: 2005 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)
The company has continuously been widening its portfolio since its foundation. Nowadays we provide more than 60 kinds of diagnostic devices in vitro (IVDs) which help in laboratories of human and veterinary microbiology to identify the inflictor of infectious disorders efficiently and quickly.
Some of our products can also be used in laboratories which specialize on food microbiology. Diagnostic devices are specialized on serological identification (e.g. latex agglutination sets, antiserum for slide agglutiation, detection of antistreptolysin O), and on exploiting enzymatic features of micro-organisms (e.g. stafylococci or enterobacteria). Diagnostic discs and preparations for medical mycology (e.g. antifungal discs and antigens for agar precipitating reactions) are the fundamental part of the company production.
In the area of biological and microbiological tests the company carries out almost 10 kinds of tests for manufacturers of pharmaceuticals and medical devices (e.g. the test for pyrogens (the only laboratory in Czech Republic), the test of abnormal toxicity, the test for sterility, microbial assay of antibiotics, tests for endotoxins, the test for the total number of micro-organisms, the test for specified micro-organisms, the estimation of population of microorganisms on product- bioburden, etc.). All tests are performed according to Ph.Eur, eventually according to USP.
Moreover, 6 testing methods are also accredited according to EN ISO/IEC 17025:2005 by CAI.
We also ensure monitoring of microbiological contamination of cleanrooms for manufacturers of medical devices and pharmaceuticals. The measurements ranges from air, surfaces and equipment to staff monitoring from microbiological aspect.
The Quality Policy is based on the effort of all our employees to satisfy the needs of every customer through supplying high quality products or services in a timely manner. Our flexibility also enables to meet customers’ requirements.