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
- 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: 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 50 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 agglutination.) Diagnostic and antifungal discs are the fundamental part of the production.
In the area of biological and microbiological tests the company carries out following tests for manufacturers of pharmaceuticals and medical devices:
- the test for sterility,
- microbial assay of antibiotics,
- tests for endotoxins – gel-clot method, kinetic turbidimetric method,
- the test for the total number of micro-organisms,
- the test for specified micro-organisms,
- the estimation of population of microorganisms on product- bioburden.
All tests are performed according to Czech Pharmacopoeia, Ph.Eur, eventually according to USP.
5 testing methods for medical devices are also accredited according to EN ISO/IEC 17025:2018 by Czech Accreditation Institute (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 point of view.
The Quality Policy is based on the effort of all our employees to meet the customer requirements through supplying high quality products or services assuring quality, objectivity and consistency of laboratory procedures in a timely manner.