Microbiology

The Importance of Microbiological Quality Assessment

Microbiological quality is critical in cosmetics product safety assessment. European Cosmetics Regulation (EC 1223/2009) requires to provide evidences of microbiological quality of cosmetic formula, raw materials, bulk, finished products and to provide evidences of preservation challenge test.

Specific tests, performed in accredited laboratories for cosmetic matrix and in compliance with validated norms and guidelines, are fundamental tools for safety assessors to assess the microbiological risk in cosmetic product manufacturing. The determination of Microbiological quality evaluation typically includes the analysis of the contamination on the product (in most cases through routine testing taking into account quantitative and qualitative specifications as the absence of specified microorganisms) and their robustness against microbiological contamination, evaluated assessing the product preservative system (challenge testing).

Microbiological Control: R&D and Routine Quality Control

Eurofins companies support its clients by carrying out complete range of testing and services, in accordance with industry standards and current regulations (ISO, EP, USP, JP or local/clients norms).

Microbiological Quality Control of Products

• Total Counts TYMC and TAMC (ISO 21149 and ISO 16212 standards, European Pharmacopoeia (EP) Chap. 2.6.12, USP <61>, PCPC M-1)
• Detection and identification of specified microorganisms (ISO 21150 (Escherichia coli), ISO 22718 (Staphylococcus aureus), ISO 18416 (Candida albicans), ISO 22717 (Pseudomonas aeruginosa) standards, EP 2.6.13, USP <62>)
• Detection and identification of specified and non-specified microorganisms (ISO 18415 standard)
• Sterility tests (according to USP <71>)

Validation - Method Applicability

• Neutralisation of antimicrobial product properties
• Validate diluent/neutraliser broth and dilution factors

Evaluation of antimicrobial protection of cosmetic products

• Challenge Test (according to the NF EN ISO 11930 standard, EP 5.1.3, USP <51>, PCPC M-3, PCPC M-5)
• Accelerated stability testing at 40°C and relative humidity testing at 75%
• Screening (preservative system of the formula)
• Measurement of water activity (aW) (EP 2.9.39, USP <1241>, USP <1231>)

Validation of growth medium (Sterility, Fertility, Inhibition, Selectivity)

Surface and Atmospheric Controls

Microbiological water analyses

Customised micro testing

Identification and Characterisation

If you are looking to:

• identify precisely the germ(s) contaminating your products, as part of your OOS investigation, in order to eliminate or limit the source of contamination or;
• to characterise the flora present in your industrial environment, by isolating germs through cleaning / disinfection validation campaigns.

Eurofins network of companies  offers solutions to identify these microorganisms:

• identification by mass spectrometry (MALDI-TOF): state-of-the-art technique used to precisely and rapidly identify bacteria and yeasts.
• identification by PCR-sequencing: gene or genome sequencing to identify bacteria, yeasts and moulds.

For more information on how we can help contact your local representative.