Fact sheet on Escherichia coli (E. coli)

General
Escherichia coli (E. coli) belongs to the family Enterobacteriaceae and is a natural intestinal inhabitant of humans and animals. They are able to survive for long periods in the environment and are considered an important hygiene indicator. Detection may indicate insufficient hygiene measures in personnel hygiene or during manufacture, filling or storage. For cosmetic products, ISO 17516 requires the absence of E. coli in 1 g.

Characteristics

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

Origin / Occurrence

• Natural inhabitant of the intestinal tract of humans and animals.
• Since some members can survive for long periods in the environment outside the intestine, they also occur in soil, in plant raw materials and in surface water.

Significance

• Hygiene indicator pointing to contamination of fecal origin.
• Indicator of insufficient production and personnel hygiene.
• Survives long in the environment → multiple contamination sources should be considered, e.g. contaminated plant raw materials, contaminated water or personnel hygiene failures.

Growth conditions

• Temperature:
  
  • Optimum: +30 °C to +37 °C
  • Minimum: +7 °C
  • Generally no growth above +50 °C
• pH value: Growth at 4.4 to 9.0.
• a_w-value: Multiplication at a water activity of at least 0.95.
• Oxygen requirement: Growth with and without oxygen (facultative anaerobe).

Inactivation by heating

• At +72 °C for at least 2 minutes exposure time (Note: monitor core temperature).

1. Review cleaning and disinfection procedures:
   1. Hygiene plan with details on how cleaning and disinfection are to be performed, e.g. dosage, contact time, use of suitable and clean materials and cleaning cloths
2. Train employees regarding potential errors and corrective measures
3. Perform repeated cleaning and disinfection
4. Verify effectiveness by on-site inspections and follow-up testing (e.g. contact plate and swab tests)

1. Check incoming goods for e.g. shelf life, packaging, deviations or microbiological abnormalities
2. This also applies to materials before use in production. In case of suspicion, do not use the raw materials
3. Review microbiological specifications. If necessary, arrange laboratory testing of suspicious products or request results from the supplier
4. Verify effectiveness by follow-up testing

1. Ensure compliance with the formulation
2. If necessary, perform a preservative efficacy test (challenge test)
3. Adjust the preservation system if required
4. Verify effectiveness by repeating the preservative efficacy test

1. Review and document production processes
2. Train staff
3. Verify effectiveness by regular microbiological product testing

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 employees regarding potential errors and corrective measures
3. Verify effectiveness by on-site inspections and follow-up testing

1. Check airborne microbial counts and ventilation systems by technical inspection as well as carry out environmental investigations
2. Avoid high humidity and formation of condensation
3. Proper cleaning and disinfection (see section “Cleaning and Disinfection”)
4. Train employees regarding potential errors and corrective measures
5. Verify effectiveness by on-site inspections and follow-up testing

1. Train employees regarding hand and personal hygiene, potential errors and behavior in case of certain illnesses
2. Monitor hand hygiene, glove changes and the cleanliness of work clothing
3. Verify effectiveness by on-site inspections and follow-up testing (e.g. contact plate and swab tests)