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COSMETICS PRESERVATION they can be tested instead ore in addition to pathogenic species. The schülke KoKo test includes these microorganisms, selected using decades of experience from schülke’s support services to cosmetic producers through the scope of MQM (Microbiological Quality- Management). Only the schülke KoKo test completely fulfil recommendations of the SCCS Notes of Guidance. ■ Cultivation of Test Microorganisms The cultivation of the test germs is comparable for all methods including the schülke KoKo test. Fig. 1 shows the procedure of single-strain cultivation on agar plates. Table 3 Microorganisms used for CTFA / M-4 Method for Preservation Testing of Eye Area Cosmetics ■ Production of Inoculum For the production of an inoculum, microorganisms are washed off from the nutrient media. For the production of an inoculum, microorganisms are washed off from the nutrient media plates and adjusted to the required starting germ count by dilution. The inoculum is then directly used to inoculate the test samples according to ISO 11930, Ph. Eur. 7 and ASEAN. The CTFA tests accepts the use of either as well pure or mixed culture suspensions, the schülke KoKo test uses mixed culture suspensions (i.e. single cultivated microorganisms brought together into a mixed suspension). To guarantee a constant composition of the mixed inoculum the mixed suspension is stored for maximum of three days in a refrigerator. A new inoculation suspension is prepared for each inoculation cycle. ■ Inoculation of Samples The microorganism counts used and the quantity of the inoculum are demonstrated in Table 4. All tests have similar germ loads in the inoculated sample. The total germ count of the inoculum for the schülke KoKo test was slightly higher to ensure safe preservation to compensate for less clean Fig. 1 Cultivation of test germs for the schülke KoKo Test production facilities. As there is now the legal demand to produce cosmetic products according to ISO 22716 (Guidelines on Good Manufacturing Practices) (9), the germ count has recently been adapted bringing it into line with the other test models. ■ Criteria of Acceptance ISO 11930 (Table 5) If the formulation meets criteria A, the microbiological risk is considered to be tolerable (the cosmetic product is protected against microbial proliferation that may present a potential risk for the user) and the cosmetic product is deemed to meet the requirements of this International Standard without additional rationale (1). If the formulation meets criteria B, the microbiological risk analysis shall demonstrate the existence of control factors not related to the formulation; for example, a protective package such as a pump provides a higher level of protection than a jar (see Annex D, ISO 11930). 46 SOFW-Journal | 138 | 7-2012
COSMETICS PRESERVATION Table 4 Microorganism counts and the quantity of inoculum used for challenge testing This would be considered a protective device for risk reduction (1). If the formulation meets criteria B, the microbiological risk analysis shall demonstrate the existence of control factors not related to the formulation; for example, a protective package such as a pump provides a higher level of protection than a schülke KoKo test (Table 6) If a sample passes criteria A, this means that even after the sixth inoculation no microbial growth can be observed, the product can be considered to be well preserved. From many years of experience in the use of this test method, if a product passes criteria A we can state the microbiological stability of 30 months, which is recommended for cosmetic products. Table 5 ISO 11930 / Criteria of acceptance 48 SOFW-Journal | 138 | 7-2012
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