Study on the precision of the preservation test method among facilities
2007
Mori, M.(Eszai Co. Ltd., Honjo, Saitama (Japan). Analytical Research Labs.) | Nitta, H. | Sakai, I.
This study was carried out in thirteen pharmaceutical companies to verify the precision of the antimicrobial preservation testing among these facilities. Results using the test method, outlined in the technical section on eye drops in the technical handbook published by the 'Pharmaceutical Manufacturers' Association of Tokyo and Osaka Pharmaceutical Manufacturers' Association,' were compared with those using each in-house method. This study showed that the precision of test results among the facilities was improved by using the technical handbook method. Further standardization will be necessary for the method to prepare test strains such as Staphylococcus aureus, Pseudomonas aeruginosa, and Aspergillus niger, which have variable dispersibility and sensitivity. Moreover, the results suggest that it is important to standardize the brand of media, storage conditions of the test strains, and the material of the containers used for the preparation of samples for further improvement in precision.
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