ГОСТ ISO 29621-2013 Продукция косметическая. Микробиология. Руководящие указания по оценке риска и идентификации продукции с микробиологически низким риском (Переиздание)

[1]

Sillikier J.H. et al., eds. for the International Commission on Microbiological Specifications for Food, Microbiology Ecology of Foods, 1, Academic Press, Orlando, Fl, pp.76-91, 1980

[2]

Curry J., Water Activity and Preservation, Cosmetic and Toiletries, 100, pp.535-554, 1985

[3]

Troller A., Effects of and pH on growth and survival of Staphylococcus aureus. In: Properties of Water in Foods, Stimatos D. and Multon J.L., eds., Martinus Nijhoff , Dordecht, 1985

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Pitt J.I., Resistance of some food spoilage yeasts to preservatives, Food Technology, 26(6), pp.238, 239, 241, 1975

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Kabara J.J. and Orth D., Preservative Free and Self Preserving Cosmetics and Drugs, Marcel Dekker, pp.1-14, 1997

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Obukkowho P. and Birman M., Hair curl relaxers, Cosmetic and Toiletries,107 (12), pp.39-43, 1992

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Leistner L., Hurdle technology applied to meat products of the shelf stable product and intermediate moisture types. In: Properties of Waters in Foods, Simatos D. and Multon J.L., eds., Martinus Nijhoff, Dordecht, 1985

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Kabara J.J. and Orth D.S., Principles for product preservation in preservative-free and self-preserving cosmetics and drugs, Marcel Dekker, New York, p.248, 1997

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Bandelin F.J., Antibacterial and preservative properties of alcohols, Cosmetic and Toiletries, 92, pp.59-70, 1977

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Block S., Disinfection, Sterilization and Preservation, 4 Edition, Lea & Febiger, p.892, 1991

[11]

Block S., Disinfection, Sterilization and Preservation, 4 Edition, Lea & Febiger, pp.167-172, 1991

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Kabara J.J. and Orth, D.S., Principles for product preservation in preservative-free and self-preserving cosmetics and drugs, Marcel Dekker, New York, pp.1-14, 1997

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Ibrahim Y.K.E. and Sonnag H.G., Preservative potentials of some aerosol propellants - Effectiveness in some pharmaceuticals, Drugs made in Germany, 2, 1995

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Ibrahim Y.K.E, Geiss H.K. and Sonnag H.G., Alternatives to traditional preservatives, SOFW Journal, 118, Jahrgang 6/92

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Commission SFSTP, Declerck J., Caire-Maurisier F., Genot P., Levacher E., Michaut A., Scheiber G. and Tardivet S. Les gaz propulseurs: Les HFC (hydrofluorocarbones) alternatives aux CFC, Pharmapratiques, 16, No. 1, pp.61-72, 2006

[16]

Meier M., Fisher F.X., Keller M. and Halfmann H.-J., Influence of alternative propellants on microbial viability in comparison to chlorofluorocarbons, Pharm. Ind., 58, pp.78-82

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Sawyer E., Green B. and Colton H., Micro-organisms survival in non-CFC propellants P11 and P12, Pharmaceutical Technology, pp.90-96, 2001

[18]

Microbial Ecology of Foods - Factors Affecting Life and Death of Microorganisms, International Commission on Microbiological Specifications for Foods, Academic Press, pp.16-19, 1980

[19]

Brannan D.K. and Dille J.C., Type of closure prevents microbial contamination of cosmetics during consumer use, Appl. Environ. Microbiol., 56, pp.1476-1479, 1990

[20]

Recommendations Relating to Period After Opening (P.A.O) Assessment - Division for the Evaluation of Advertising, Cosmetics, and Biocides: European Commission (04/ENT/COS/28) March 11, 2005

Активность воды

[21]

US Pharmocopeia, chapter 1112 - Application of Water Activity Determination to Non-sterile Pharmaceutical Products, 2007

[22]

Scott W.J., Water relations of Staphyloccocus aureus at 30°C, Austral. J. Biol. Sci., 6, p.549, 1953

[23]

Serber W.H., Influence of water activity on foodborne bacteria: a review, J. Food Protect., 46(2), pp.142-150, 1983

[24]

Friedel R.R., The Application of Water Activity Measurement to Microbiological Attributes Testing of Raw Materials Used in the Manufacture of Non-Sterile Pharmaceutical Products, Pharmacopeial Forum, 25(5), pp.8974-8981, 1999

[25]

Enigl D.C., Creating Natural Preservative Systems by Controlling Water Activity, Pharmaceutical Formulation & Quality, 29-30, 1999

[26]

Enigl D.C. and Sorrels K., Preservative-Free and Self-Preserving Cosmetics and Drugs Principles and Practice, Marcel Dekker, Chapter 3 Water Activity and Self-Preserving Formulas, pp.45-73, 1997 См. также [2].

pH

[27]

Food Preservatives, 2 Edition, Russel, N.J. and Gould, G.W. eds, Kluwer Academic/Plenum Publishers, pp.25- 42, 2003

[28]

Silliker J.H. et al. eds. for the International Commission on Microbiological Specifications for Food, Microbial Ecology of Foods, 1, Academic Press, Orlando, FL, pp.92-111, 1980

[29]

Cosmetic Microbiology, A Practical Handbook, Brannan, D., ed., CRC Press, pp.47-49, 1991

Высокая температура

[30]

International Dairy Foods Association, http://www.idfa.org/facts/milk/pasteur.cfm

[31]

Microbial Ecology of Foods - Factors Affecting Life and Death of Microorganisms, International Commission on Microbiological Specifications for Foods, Academic Press, pp 16-37, 1980

Окислители

[32]

Harrison S. and Sinclair R., Hair Coloring, Permanent Styling and Hair Structure, Journal of Cosmetic Dermatology, 2, p.180, 2003

См. также [6].

Упаковка/Укупоривание

[33]

Brannan D.K., Packaging's Role in Preservation, Cosmetics and Toiletries, 113, 1998

См. также [12], [19].

Пропелленты

[34]

Ibrahim Y.K. and Sonntag H.G., Effect of formulation pH and storage temperatures on the preservative efficacy of some gases used as propellants in cosmetic aerosols, J. Appl. Bacteriol., 74, p.20, 1993

[35]

Klepak P.B. In Vitro Killing Time Studies of Antiperspirant Salts, Z. Aerosol. Parf. Seifen Ole Fette Wachse, 13, p.478, 1990

См. также [13], [14], [15], [16], [17].

Спирты

[36]

Pinon A. et al., Growth, survival and inactivation of Pseudomonas aeruginosa and Staphylococcus aureus strains of various origin in the presence of ethanol, International Journal of Cosmetic Science, 29, pp.111-119, 2007

[37]

Cosmetic Microbiology, A Practical Handbook, Brannan, D., ed., CRC Press, pp.167-168, 1991

[38]

Baird and Bloomfield, eds., Microbial Quality Assurance in Cosmetics, Toiletries and Non-Sterile Pharmaceuticals, 2 Edition, Taylor and Francis Ltd., London 1996

Оценка риска/Статистика

[39]

Managing Quality Risk Management Implementation, PDA Letters, 18, pp.1-13, 2007

[40]

Coleman M.E. et al., Microbial Risk Assessment Scenarios, Causality and Uncertainty, Microbe, 2, pp.13-17, 2007

[41]

Durkee J., It's a Two-edged Sword, The Magnificent 7 Controlled Environments, 10, p.34, 2007

[42]

Durkee J., The "Magnificent Seven" - Part ll. Controlled Environments, 10, p.28, 2007

[43]

Cohen N., The Use of Exponentially Weighted Process Statistics (EWPS) and Statistical Process Control (SPC) in High Frequency Data Acquisition of Pharmaceutical Water Systems Instrumentation, Pharm Eng. 27, pp.72-82, 2007

[44]

H., Schneider B. et al., Out-of Specification Test Results from the Statistical Point of View, J Pharmacol and Biomedical Analysis, 44, pp.718-729, 2007

[45]

Liu Y., Overview of Some Theoretical Approaches for Derivation of the Monod Equation, Appl. Microbiol Biotechnol., 73, pp.1241-1250, 2007

[46]

McClure F. and Lee J., Exact One-Tailed 100% Upper Limits for Future Sample Repeatability Relative Standard Deviations Obtained in Single and Multilaboratory Repeatability Studies, J AOAC International., 90, pp.1701-1705, 2007

[47]

Microbiological Risk Factor Assessment of Atypical Cosmetic Products, CTFA Microbiology Guidelines, Cosmetic Toiletry and Fragrance Association, 2007

[48]

Method for Preservation Testing of Atypical Cosmetic Products, CTFA Microbiology Guidelines, Cosmetic Toiletry and Fragrance Association, 2007

[49]

International Conference on Harmonization, Q6A - Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products Decision Tree 6, 1999

[50]

Principles and Guidelines for the Conduct of Microbiological Risk Assessment CAG/GL 30, 1999

Международные стандарты

[51]

ISO Guide 73

Risk management - Vocabulary (Менеджмент риска. Словарь)

[52]

ISO 18415

Cosmetics - Microbiology - Detection of specified and non-specified microorganisms (Косметика. Микробиология. Обнаружение специфических и неспецифических микроорганизмов)

[53]

ISO 18416

Cosmetics - Microbiology - Detection of Candida albicans (Косметика. Микробиология. Определение Candida albicans)

[54]

ISO 21150

Cosmetics - Microbiology - Detection of Escherichia coli (Косметика. Микробиология. Определение Escherichia coli)

[55]

ISO 22716

Cosmetics - Good Manufacturing Practices (GMP) - Guidelines on Good Manufacturing Practices [Косметика. Надлежащая производственная практика (GMP). Руководящие указания по Надлежащей производственной практике]

[56]

ISO 22717

Cosmetics - Microbiology - Detection of Pseudomonas aeruginosa (Косметика. Микробиология. Определение Pseudomonas aeruginosa)

[57]

ISO 22718

Cosmetics - Microbiology - Detection of Staphylococcus aureus (Косметика. Микробиология. Определение Staphylococcus aureus)

УДК 665.58:006.354

МКС 07.100.99

71.100.70

Ключевые слова: косметическая продукция, микроорганизмы, микробиологически низкий риск, микробное загрязнение, активность воды, оценка риска, критерий риска