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info@t-injecta.sk     +421 32 7709 991     

Accredited laboratory methods

laboratory

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 ISO/IEC 17025:2017 in 2019 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.

Test subject Parameter Prescription
Medical devices, Infusion
and Injection solutions   
Sterility test EuPh. 2.6.1
Bioburden test EN ISO 11737 - 1,2
Bacterial endotoxin test EuPh. 2.6.14
Invisible particles in fluid EuPh. 2.9.19
Air in the clean rooms Non - viable partical contamination EN ISO 14644, part 1-5, 7
Viable partical contamination EN ISO 14698 - 1,2
Prints/swabs from surfaces and equipments Microbial contamination of surfaces EN ISO 14698 - 1,2

pdf-iconCertificate (pdf)