Fact sheets

Fact sheet on Pseudomonas aeruginosa and pseudomonads

Fact sheet on Pseudomonas aeruginosa and pseudomonads

Fact sheet on Pseudomonas aeruginosa and pseudomonads in cosmetics

General information
Pseudomonads belong to the family Pseudomonaceae. Of particular relevance for cosmetics is the species Pseudomonas aeruginosa, as it is a frequent cause of wound or urinary tract infections. In water-containing cosmetics, Pseudomonas aeruginosa can grow in the absence of adequate preservation. Detection of these bacteria can indicate inadequate hygiene measures during manufacture, filling or storage. The hygiene status of the water used (process water, water for cleaning purposes as well as for development samples) usually plays an important role. In cosmetic products, ISO 17516 requires the absence of Pseudomonas aeruginosa in 1 g.

Characteristics

  • Rod-shaped bacteria
  • Gram-negative
  • Oxidase-positive
  • Catalase-positive

Origin / occurrence

  • Widely distributed in our environment (e.g., soil, water, plants and animals).
  • Typical entry routes into cosmetics:
    • Process water (e.g., due to biofilms in pipes, tanks, hoses or stagnant water)
    • Water for cleaning purposes or cleaning solutions
    • Production equipment (hoses, pumps, agitators, filling machines)
    • Raw materials, especially water-containing ingredients or raw materials of plant origin

Significance

  • Pseudomonads play an important role in cosmetics with a high water content, as they can act as pathogens, for example causing wound infections.
  • In water hygiene, Pseudomonas aeruginosa serves as an important indicator organism. It indicates contamination and biofilms in process, drinking and mineral water, as well as in bathing water. Bathing water can also be a source of infections (e.g., wound infections).
  • In medical facilities and hospitals, Pseudomonas aeruginosa is a particularly feared pathogen for e.g., wound and urinary tract infections (a cause of nosocomial infections).

Growth conditions

  • Temperature:
    • Optimum: +25 °C to +37 °C
    • Minimum: +5 °C
    • Generally no growth above +50 °C
  • pH value: Growth at pH 5.0 to 8.0.
  • aw-value: Growth at a water activity of at least 0.95.
  • Oxygen requirement: obligately aerobic

Inactivation by heating

  • At +72 °C for at least 2 minutes exposure time (Note: monitor core temperature).
Possible causes of elevated microbial counts Suggested measures
Errors in cleaning and disinfection:
The result can be contamination of cosmetics by, for example, microbially contaminated equipment, utensils, surfaces, machines or inadequate production hygiene
  1. Check the execution of cleaning and disinfection:
    1. Hygiene plan with specifications for carrying out cleaning and disinfection, e.g., dosing, contact time, use of appropriate and clean materials and cleaning cloths
  2. Train staff regarding potential errors and corrective measures
  3. Repeat cleaning and disinfection
  4. Verify effectiveness by on-site inspections and follow-up testing (e.g., contact plate and swab tests)
Use of microbially contaminated water:
If microbially contaminated water is used for cleaning or production and there are no effective inactivation steps in subsequent production steps, the product may also be potentially microbially contaminated
  1. Check water systems and piping for correct function and condition. Avoid stagnation of water in e.g., pipes, systems, hoses…
  2. Regularly test water systems and piping microbiologically and technically (observe maintenance intervals)
  3. In case of contamination of water systems, respond immediately and initiate measures. Involve specialist companies if necessary
  4. Verify effectiveness by regular follow-up testing
Use of microbially contaminated raw materials:
If microbially contaminated raw materials are used for production and there are no effective inactivation steps in subsequent production steps, the product may also be potentially microbially contaminated
  1. Check incoming goods for e.g., shelf life, packaging, deviations or microbiological abnormalities
  2. This also applies to the goods before use in production. Do not use raw materials if there is any suspicion
  3. Verify microbiological specifications. If necessary, arrange laboratory testing of suspicious products or request results from the supplier
  4. Verify effectiveness by follow-up testing
Faulty preservative system:
An inadequate preservative system results in undesired multiplication or insufficient inactivation of microorganisms
  1. Ensure compliance with the formulation
  2. Possibly perform a preservative efficacy test (challenge test)
  3. Possibly adjust the preservative system
  4. Verify effectiveness by a repeat preservative efficacy test
Production errors:
Faulty processes, e.g., due to insufficient mixing times, deviations from the formula, insufficient heating or cross-contamination
  1. Check and document production processes
  2. Staff training
  3. Verify effectiveness by regular microbiological product testing
Inadequate separation of “clean and unclean”:
The result can be unwanted contamination of clean work areas, equipment or low-microbial raw materials/products with microorganisms originating from “unclean” activities or raw materials with high microbial loads (cross-contaminations)
  1. Review work organization in the facility
    1. separate work areas, equipment and utensils
    2. separation of “clean” and “unclean” areas and activities
  2. Train staff regarding potential errors and corrective measures
  3. Verify effectiveness by on-site inspections and follow-up testing

 

Further information and literature

https://www.bfr.bund.de/produktsicherheit/gesundheitliche-bewertung-von-kosmetischen-mitteln/

Microbiology and Operational Hygiene Working Group of the DGK e.V.
General information and publications
https://dgk-ev.de/mikrobiologie-und-betriebshygiene

Specialist book “DGK - Operational Hygiene in Cosmetics”
https://www.sofw.com/de/shop/buecher/product/386-dgk-betriebshygiene-in-der-kosmetik-2-ueberarbeitete-ausgabe-2019

Specialist book “DGK - Preservation of cosmetic products”
https://www.sofw.com/de/shop/buecher/product/66-dgk-konservierung-kosmetischer-mittel

Cosmetics section in the Working Group Food Chemistry, Cosmetics, Consumer Products
of the GÖCH
General information and guidelines
https://www.goech.at/arbeitsgruppen/lebensmittel%2C-kosmetik-%26-gebrauchsgegenst%C3%A4nde

ISO standard 17516 on microbiological limits
https://www.beuth.de/de/norm/din-en-iso-17516/203537217

ISO standard 29621 for the classification of microbiologically low-risk products
https://www.beuth.de/de/norm/din-en-iso-29621/263888044

 

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