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 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 17141 | |
| Prints/swabs from surfaces and equipments | Microbial contamination of surfaces | EN 17141 |
Certificate (pdf)
