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2024-09-30

Blog

· R&D

/ What's New

A new service is available! Internal Microbiological Control

30 September, 2024 · 3 minutes of reading

At Neftis Laboratorios we have integrated the microbiological control service internally.

In the cosmetics industry, consumer safety and product quality are of paramount importance. At Neftis, we have integrated a key service that was previously outsourced: microbiological control.

This improvement not only allows us to control and detect possible contamination in incoming materials and finished products, preventing potential risks and market complaints, but also to optimise delivery times.

Why is microbiological assessment important?

Microbiological control of cosmetic products is a fundamental requirement to comply with current regulations, ensure product quality and guarantee consumer safety. For these controls, Neftis Laboratorios has developed rigorous and standardised analytical methods.

There are several causes that can lead to microbial contamination of the product. Some of these are:

  • Raw materials, especially those of natural origin.
  • Air quality in the processing and packaging area.
  • Equipment in the production plant.
  • Plant personnel.
  • Primary packaging.

It is therefore essential to establish routine microbiological controls at all these points, from the analysis of ingredients and raw materials to the control of the final product.

To this end, Neftis Laboratorios carries out rigorous and standardised analytical methods in accordance with the European Pharmacopoeia and the various ISO standards that regulate the different pathogens.

At Neftis Laboratorios we perform:

Microbiological quality control of high risk raw materials and finished products:

  • Total amount of non-specific micro-organisms: aerobes (TAMC) and fungi (TYMC) based on ISO 18415; ISO 21149 and ISO 16212.
  • Detection and identification of specific micro-organisms: Escherichia coli (ISO 21150), Staphylococcus aureus (ISO 22718), Candida albicans (ISO 18416) and Pseudomonas aeruginosa (ISO 22718).
  • Detection and identification of Salmonella spp. (ISO 6579-1).
  • Detection and identification of Burkholderia cepacia, a pathogen that has been implicated in recalls in recent years. Its detection is not required by current legislation.
  • Detection of 12 pathogenic strains to comply with the pathogen-free requirement of Regulation 1223/2009.

Verification of microbiological analytical methods:

The objective is to verify the validity of the analytical method of microbiological control for each cosmetic product.

Sterility test:

A precise method is used to verify that sterilised products do not contain viable micro-organisms (EP 2.6.1.).

Microbiological control of water quality:

Sampling and control of the water used for production is essential as it represents an important percentage of the cosmetic product. In this case, not only the absence of contamination is taken into account, but also its purity (pH, conductivity, endotoxins, etc.), as this influences the skin tolerance of the product.

Environmental and surface quality controls:

These are periodic checks carried out in the production areas to monitor the quality of the environment and to validate and check the effectiveness of the cleaning methods in place.

Challenge Test:

The Challenge Test (CHT), also known as the Preservative System Efficacy Test, is a test designed to ensure the efficacy of preservatives added to cosmetic and pharmaceutical products. It is very important that the test is performed and passed successfully to ensure the protection of the product against bacterial growth during its shelf life and to protect the consumer against possible infections (ISO 11930).

The integration of this new microbiological control service gives us unprecedented agility, ensuring our products get to market faster without compromising safety or quality. For further information please contact us at hello@neftislaboratorios.com!

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