Microbiological quality of non-sterile pharmaceutical products.

In microbiological terms, pharmaceutical products can be divided into two groups: sterile and non-sterile. Non-sterile drugs must satisfy the appropriate microbiological purity criteria which are included in pharmacopoeial monographs. Pharmacopoeial studies are prepared specifically with a view to ensuring that the medicinal product is therapeutically effective and safe for the patient. The analysis comprised the results of microbiological purity tests performed before the products are marketed. Total of 1285 samples of non-sterile drugs manufactured by different pharmaceutical plants in Polish were taken into study. The microbiological quality of drugs was assessed in accordance with the criteria included in the European Pharmacopoeia (EP). An analysis of test results demonstrated that the percentage of non-compliant samples was 1.87%. The groups of drugs, which the most often did not satisfy EPs' requirements, were drugs containing raw materials of natural origin (5.7%). The samples of studied drugs that did not meet the criteria contained in EP, exceed the maximum allowable microbiological count limits and contained microbes whose presence is prohibited. The most common non-compliance was the excessive levels of the maximum acceptable fungal count (n = 12) and the excessive the maximum acceptable aerobic microbial count (n = 10).

["Dermomedium" test for evaluation of microorganism count from utilizable surfaces and skin]. / Próbnik "Dermomedium" do oceny liczby drobnoustrojów z powierzchni uzytkowych i skóry.

The study was aimed at determination of usefulness of a set "dip-Slide" for quantitative evaluation of bacterial contamination of skin and utilizable surfaces in comparison with traditional methods of taking smears. Investigation were carried on by application of test strains of E. coli, P. aeruginosa, P. mirabilis, Enterobacter sp. and S. aureus. It was established that application of the set "Dermomedium" brings results comparable to traditional methods, but is cheaper and easier in practice.

[Antimicrobial conservation of some cosmetics]. / Konserwacja przeciwdrobnoustrojowa niektórych kosmetyków.

Investigations were carried on with model cream with O/W and W/O emulsion type and three selected tooth pastes produced by Pollena-Lechia. Own "conservation test" was applied for a period of 28 days basing on methods recommended by PN-80/C-77022 for cosmetics. Applied test microorganisms were recommended by National Institute of Hygiene for investigation of disinfecting agents and strains of bacteria and fungi isolated from cosmetics. Initial level of contamination amounted to 10(6) cells/g. Following biocides were used: Nipagin A, M and P, Kathon CG, Sepicide Cl, Chlor-hexidine gluconate, Myacide SP, Bromochlorophene, Germall 115, Gropol, benzalkonium bromide, Cetrimide, Irgasan DP-300 and Bronopol. Most effective biocides for creams with W/O emulsion type effective during 5 days were Gropol and Bronopol in concentration of 0.01% and Kathon CG in concentration of 0.05%. For tooth pastes optimal biocide was Sepicide Cl in concentration of 0.3% which was cidal in time of 4 days. Out of tested microorganisms most resistant to mentioned biocides were Pseudomonas aeruginosa i P. putida isolated from cosmetic creams.

[Septo-clean* new disinfecting agent and antiseptic]. / Septo-clean* nowy srodek dezynfekcyjny i antyseptyczny.

The study was aimed at evaluation of usefulness of Septo-Clean, which contain in 100 cm3 of distilled water 1 g of didecyl-dimethylammonium chloride and 70 cm3 of isopropyl alcohol. This preparation is prepared for quick disinfection of surfaces and antiseptic action on hand skin. Investigations were carried on test strains of S. aureus, E. coli, P. aeruginosa and C. albicans. It was demonstrated that MIC of Septo-Clean amount to 0.04% for S. aureus to 0.88% for P. aeruginosa. MBC 5 min values were respectively 0.19 and 1.05%. It was found that this preparation effectively lowers natural contamination with bacteria of hospital usable surfaces by 98%, exhibiting effectiveness similar to preparations containing 2.5% of chlorhexidine in 70% ethanol or isopropanol.