Published Standards ISO General instructions for microbiological examination ISO Enumeration and detection of aerobic mesophilic bacteri

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1 ISO Standards Cosmetics Microbiology TC 217 WG1 Joyce Beauchamp L OREAL USA Products, Inc PCPC Microbiology Workshop ISO TC 217 WG1 Microbiological standards and limits Secretariat IRISI Secretary Mrs. Mojdeh R. Tabari Published 9 standards Developing 1 standard 1

2 Published Standards ISO General instructions for microbiological examination ISO Enumeration and detection of aerobic mesophilic bacteria ISO Enumeration of yeast and mould ISO Guidelines for the risk assessment and identification of microbiologically low-risk products Published Standards ISO Detection of Escherichia coli ISO Detection of Pseudomonas aeruginosa ISO Detection of Staphylococcus aureus ISO Detection of Candida albicans ISO Detection of specified and non- specified microorganisms 2

3 Standards Under Development ISO/DIS Efficacy test and evaluation of the preservation of a cosmetic product Consensus Key Components Scope Flexibility Global Test conditions Neutralization 3

4 Scope This Standard gives general guidelines Risk analysis to determine to which products the standard is applicable..may not be appropriate for some products Other methods may be used Flexibility Media and Diluents Main body Others may be used if demonstrated suitable Annex Enumeration methods Pour plates Surface spread Filtration Allows for use of other methods Automated Methods Equivalence demonstrated or otherwise validated 4

5 Bibliography references CTFA Guidelines COLIPA Guidelines BAM EP, JP, USP Culture Collections Global ATCC, CIP, NCIMB, NBRC, KCTC Scope - Specified Microorganism Standards Might differ according to national practices or regulations Neutralization In all standards dealing with enumeration and detection Informative Annex Neutralizers of Antimicrobial Activity Spread plate, pour plate and filtration are validated if count ( cfu/ml) is at least 50% (0.3 log) of control count Enrichment is validated if growth is characteristic initial concentration 1-5 cfu/ml 5

6 Neutralization Failure of growth requires modification of conditions of test Increase in volume of diluent Incorporation of inactivating agents Combination of modifications If in spite of incorporation of suitable modifications cultures are not recovered, indicate that the product is not likely to be contaminated with the given species of microorganism ISO 21148:2005 General Instructions for microbiological examination 6

7 ISO Laboratory layout, location, construction, maintenance. Equipment descriptions (in some cases tolerances) Personnel Preparation and management of apparatus Preparation, storage and use of culture media Handling of laboratory samples Initial suspension prepared from at least 1 gram Operating Practices Neutralization Annexes include common techniques and procedures ISO 21149:2006 Enumeration and detection of aerobic mesophilic bacteria 7

8 ISO Enumeration or Presence/Absence Minimum 1 gram sample Incubation Enumeration : 32.5 C C for 72 h + 6 h Enr. Broth : 32.5 C C for minimum of 20 h Enr. Subcult. : 32.5 C C for h Neutralization P. aeruginosa ATCC 9027 S. aureus ATCC 6538 ISO Media & Diluents Enumeration Neutralizing Diluent: SCDLP 20 Broth Enumeration Other: Fluid A Enumeration Agar: SCDA (TSA) Detection Enrichment Broth : Eugon LT 100 Broth Enrichment Agar: Eugon LT 100 Agar Detection Annex A, B, C Examples of other neutralizing diluents, diluents and culture media that may be used 8

9 ISO 16212:2008 Enumeration of yeast and mould ISO Enumeration on selective media Incubation C for 3 5 d on selective media OR C for 5 7 d on non-selective media Neutralization C. albicans ATCC

10 ISO Media and Diluents Neutralizing Diluent: SCDLP 20 Broth Other: Fluid A Enumeration Agar: SDA with chloramphenicol Other: SDA Annex A, B, C Examples of other neutralizing diluents, diluents and culture media that may be used ISO 29621:2010 Guidelines for the risk assessment and identification of microbiologically low-risk products 10

11 ISO Risk assessment performed to determine types of products to which standards apply Defines those products which present low risk of microbial contamination, and do not require application of microbiological standards Factors include a w, ph, alcohol, other hostile materials, and process temperature Detection Standards Risk analysis parameters potential alteration of products Pathogenicity site of application Type of user Might differ according to national practices or regulations Other methods may be appropriate depending on the level of detection required Note: may use other identification steps e.g. identification kits 11

12 ISO 21150:2006 Detection of Escherichia coli ISO Detection of E. coli in non-selective media followed by isolation on selective media Enrichment C C min 20h max 72 h Streak onto MacConkey Agar and C C min 24 h - max 48 h Perform tests on suspect colonies Gram stain Streak to EMB and C C min 24 h - max 48 h 12

13 ISO 22717:2006 Detection of Pseudomonas aeruginosa ISO Detection of P. aeruginosa in non-selective media followed by isolation on selective media Enrichment C C min 20h max 72 h Streak onto Cetrimide Agar and C C min 24 h - max 48 h Perform tests on suspect colonies Gram Stain Oxidase Streak to Pseudomonas Agar P and C C min 24 h - max 48 h 13

14 ISO 22718:2006 Detection of Staphylococcus aureus ISO Detection of S. aureus in non-selective media followed by isolation on selective media Enrichment C C min 20h max 72 h Streak onto Baird Parker Agar and C C min 24 h - max 48 h Perform tests on suspect colonies Gram Stain Catalase Coagulase 14

15 ISO 18416:2007 Detection of Candida albicans ISO Detection of C. albicans in non-selective media followed by isolation on selective media Enrichment C C min 20h max 72 h Streak onto SDA with Chlroamphenicol and C C for h Perform tests on suspect colonies Gram Stain Germ Tube Chlamydospores 15

16 ISO 18415:2007 Detection of specified and non-specified microorganisms ISO Enrichment in non-selective media followed by isolation on non-selective media Enrichment C C min 20h max 72 h Streak onto TSA and C C for h Perform Tests on colonies Gram stain Catalase if gram + Oxidase if Gram Identification kits 16

17 Bacteria Fungi Comparison of Methods ENR 32 ISO Cosmetics C 72 h + 6 h C 3 5 d OR C 5 7 d C min 20 h, then C h CTFA USP C Min 48 h C Min 5 d C h C 5-7 d NA C h Then vary by specified ISO/DIS Efficacy test and evaluation of the preservation of a cosmetic product 17

18 ISO/DIS To determine the ability of cosmetic products to resist microbial contamination during use Includes combinations of factors: Challenge test Packaging Risk analysis Applied to marketed products Other test may be used during development Updates and Revisions Standards up for systematic review every three years 21148, 21149, 21150, and have not been opened for revision A corrigenda proposed by AFNOR to replace validate with suitability 18

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