COSMETICS MICROBIOLOGY

COSMETICS MICROBIOLOGY

Evolution of cosmetic microbiology: From Pharmacopoeia to ISO Standards for cosmetic microbiology. Reasons why cosmetics are still being recalled. Even by large companies. Solutions to avoid such recalls and sanctions.

Not many years ago, cosmetic microbiology was the same as pharmaceutical microbiology. But the first thing the Pharmacopoeia says is that it is validated for medicines (i.e. not for cosmetics).

Once this reality was confirmed, MICROKIT designed the first proficiency service for cosmetics microbiology in 2005.

And indeed, the results were devastating: almost all participating laboratories obtained yields of only 40 to 60%.

That is, out of every 10 analyses, between 4 and 6 false positives or false negatives were obtained.

It was very clear that Pharmacopeia was not useful for cosmetics.

Shortly afterwards, the ISO Standards for cosmetics microbiology were approved and 3 mistakes were made in them:

1) Too closely emulating the Pharmacopeia method, which gave such poor results in cosmetics

2) Focusing on 4 pathogens/indicators (Candida albicans, Staphylococcus aureus, E.coli and Pseudomonas aeruginosa) and forgetting about emerging pathogens (since ISO 18415 on «specified and unspecified microorganisms» does not solve the problem; because simply strikes enriment broth in TSA, In which harmless microorganisms also grow. This waste the time of laboratories, which are forced to identify them all even if they are not pathogenic.).

3) And they also forgot about the critical waters for cosmetic use, in which no one at the water treatment plant looks for the microorganisms that cause the most problems in cosmetics. Because the legislation on water for human consumption does not contemplate them

The results of the laboratories in successive rounds of these cosmetic intercomparative services (once the ISO Standards for cosmetic microbiology were implemented in many of its participants), were better than those of the Pharmacopoeia, but still had much room for improvement. Especially in highly ubiquitous emerging pathogens, like Burkholderia cepacia or Pluralibacter gergoviae.

Time has shown that there were up to 10 emerging pathogens to add to the 4 with specific ISO standards. Pathogens that created numerous and high-profile market recalls. Because only health authorities were looking for them, not the cosmetics industries or the external laboratories to which they entrusted their analyses.

It was understandable that the cosmetics industry is opposed to adding 10 new culture media to its analyses in addition to the 4 they already used, in order to guarantee that its cosmetics are microbiologically safe and harmless, as required by EC Regulation 1223/2009 (the only legislation on the subject).

But what if you only needed to add one culture medium to detect the remaining 10 pathogens? Without false positives of harmless ones (like TSA) or false negatives.

This idea had been floating around in MICROKIT’s head for a long time. And after overcoming the fears of what seemed impossible at first sight, MICROKIT achieved it!

A single culture medium that detects the 10 emerging pathogens that do not have an associated ISO standard (and also two of those that do).

Could you ask for more?

This magic and blessed medium has been called CUP12A (Cosmetic Universal 12 Pathogen Agar) and it’s available since 2023.

https://www.microkit.es/eng/fichas/CROMOKIT%20CUP-12%20AGAR%20Cosmetic%20Universal%20PathoChrom%20Agar.pdf

You just have to add it to the 4 that everyone uses, to be sure that you will not continue to suffer the uncertainty of a probable market withdrawal.

On the other hand, we offer the neutralizing broth that obtains the best results when used in intercomparison. Another fruit of these 15 years of intercomparing results between cosmetic laboratories: LPTN Broth (derived from Eugon and Modified Letheen, but with doping factors and with neutralizers of all current authorized preservatives).

https://www.microkit.es/eng/fichas/LPT-NEUTRALIZING%20BROTH%20COLOURLESS.pdf

And to speed up aerobic and fungal counts (in just 18-36h) we offer two other magical media: RYM Agar and Maxim Agar (a chromogenic PCA derivative):

https://www.microkit.es/eng/fichas/RAPID%20SABOURAUD%20RYM%20AGAR.pdf

https://www.microkit.es/eng/fichas/pca%20cromogenic%20EN.pdf

Finally, for manufacturers who do not yet have their own self-control laboratory, we have designed a prepared media kit containing everything we have described above (including all the necessary consumables), the COSMETIKIT-EASYPLUS. You only need a culture incubator and this kit to be able to start performing your own analyses of the 14 pathogens, since the kit also includes the neutralization of preservatives and the counting of aerobes and molds:

https://www.microkit.es/eng/fichas/COSMETIKIT%20EASYPLUS%20EN.pdf

 

And for those who want to follow more thoroughly the GMPs reflected in ISO 22716 (mandatory implementation in cosmetic factories), we offer the complete microbiological water analysis kit, which includes the most important parameters of water potability, and also the two emerging ones that cause the most problems in cosmetic waters: Pseudomonas aeruginosa and Burkholderia cepacia: COSMETIKIT WATER:

https://www.microkit.es/eng/fichas/COSMETIKIT%20WATER%20EN.pdf

 

We also offer all the quantitative strains needed for quality control and high-load strains for Challenge Test. Request a stock list with exact loads and expiration dates:

https://www.microkit.es/eng/fichas/QUANTITATIVE%20MICROBIOLOGICAL%20STRAINS%202017.pdf

 

And to validate the cleanliness of your facilities, use the simplest kit, with very evident results, which does not require any equipment; and with an immediate response, by turning green, when organic matter poses a risk of microorganism accumulation, the KitProPlus:

https://www.microkit.es/eng/fichas/kitpro%20PLUS%20EN.pdf

Another advancement we offer is the hermetic prepared plates with a long shelf life (5 real months) and the dehydrated plates with a shelf life of 1-2 years:

https://www.microkit.es/eng/fichas/plaquis%20hermetic%20EN.pdf

https://www.microkit.es/eng/fichas/Dry%20Plates%202021%20EN.pdf

https://www.microkit.es/eng/fichas/MICROKIT%20export%202024%20Catalogue.pdf

 

Take advantage of all of MICROKIT’s experience in cosmetic microbiology (34 years of innovation). MICROKIT, your best ally; ask us what you need to know at: export@microkit.es

If you want to order some MICROKIT product, please send your order to: pedidos@microkit.es

 

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