The Department performs:
– Testing the sterility of medicaments and medical devices that are declared as sterile (technique Membrane filtration and direct method, Ph. Eur. 2.6.1);
– Examining microbiological purity of non-sterile products according to Ph. Eur. (5.1.4.-1 and -2) as raw materials for medicines, drugs prepared for oral, local or rectal application, herbal preparations, primary packaging, such as capsules, Al / PVC-foil, glass bottles, plastic vials, alveoli suppository etc. (Ph. Eur., 2.6.12, 2.6.13.);
– Bacteriological purity testing of cosmetic products (Fig. Gazette no. 94/10).
Besides these activities there is a professional assessment delivered pharmaceutical-chemical and biological documentation in order to obtain a marketing authorization for the medicinal product, renewal of authorization of the medicinal product, application of variation and more.
