Accredited laboratory methods
Microbiological laboratory – an independent unit of the company CHIRANA T. Injecta a.s. performs microbiological, biological and physico-chemical tests of medical aids, samplings and analyses of working environment air and surfaces. Qualiﬁcation to perform tests without prejudice, trustworthy, precisely, correctly and in required quality has the laboratory proved by fulﬁllment of requirements of the Standard STN EN ISO/IEC 17025:2005 in 2009 and by obtaining the Accreditation Certiﬁcate no. S-264.
Employees of the laboratory take in their work advantage of their long-term experiences and expert knowledge in the ﬁeld of tests of medical aids in accordance with European Pharmacopoeia and relevant international normative requirements, as well as monitoring of air-conditioned clean production premises and laminar boxes, with regard to microbial pollution and contamination by dust particles.
|Medical devices, Infusion
and Injection solutions
|Sterility test||EuPh. 2.6.1|
|Bioburdern test||STN EN ISO 11737 - 1,2|
|Bacterial endotoxin test||EuPH. 2.6.14|
|Invisible particles in fluid (N/ml)||EuPh. 2.9.19|
|Air in the clean rooms||Non - viable partical contamination (N/m3)||STN EN ISO 14644 1-7|
|Viable partical contamination (CFU/m3)||STN EN ISO 14698 - 1,2|
|Prints/swabs from surfaces
|Microbial contamination of surfaces (CFU/100 cm2)||STN EN ISO 14698 - 1,2|