Profile on "Campylobacter" ("Thermotolerant Campylobacter")

General Information and Origin

Bacteria of the genus Campylobacter are heat-sensitive germs, some of which cause intestinal infections, usually with abdominal pain, vomiting, and diarrhea. Further complications are rare but can occur (e.g., infection of other organs and joint inflammation).

The most important pathogenic species for humans are C. jejuni and C. coli, with the minimum infectious dose ranging from 100 to 1,000 germs. These species belong to the thermotolerant Campylobacter. Transmission to humans mainly occurs through raw or undercooked poultry meat, poultry offal, and raw milk, but also through cross-contamination. The bacteria are found in the intestinal tract of numerous animals (warm-blooded wild, farm, and domestic animals).

Importance

Due to the heat sensitivity of these bacteria, effective killing is assured by heating steps of at least +72 °C for a minimum of 2 minutes. They can survive in vacuum packs or under a protective atmosphere and at chilling temperatures for several weeks. In food, reproduction typically does not occur. However, this is not a condition to pose a health hazard, as even low germ counts can cause illness.

Campylobacter gastroenteritis has been the most common cause of bacterial food infections in Germany and many other European countries for years.

Important Causes of Elevated Germ Counts

• Insufficient heating of food
• Cross-contamination between raw and processed foods
• Hygiene errors during manufacture (e.g., contaminated work tools, surfaces, and equipment,...)
• Processing of contaminated raw materials (particularly poultry meat is relatively frequently contaminated)
• Contamination of vegetables and other plant-based foods through fertilizers or contaminated water

Growth Conditions

• Temperature: Growth at 25 – 47 °C
• pH value: Growth at 4.9 – 9.0
• aw value: Growth down to min. 0.98
• Salt tolerance: 0.16 – 1.55 %, but strongly influenced by temperature and pH value
• Oxygen requirement: microaerophilic, growth only under a reduced oxygen atmosphere

At What Temperatures Do These Microorganisms Die?

Generally, it can be assumed that these bacteria are killed by heating to +72 °C for at least two minutes or by an equally effective process. In food, it should be ensured that this temperature-time combination is reached in the core of the product to safely kill the bacteria.

Further Information and Literature

• www.rki.de: under "Infectious Diseases A-Z"
• www.bfr.bund.de: under "Food Safety"
• www.lgl.bayern.de: under "Food" and then "Hygiene"
• Pathogenic Microorganisms: Campylobacter Volume II, G. /F. Reich Behr’s Publishing, 1st Edition 2013
• Food Microbiology, J. Krämer and A. Prange, 7th Edition 2017
• Microorganisms in Food, H. Keweloh, 2nd Edition 2008
• Handbook of Food Hygiene, K. Fehlhaber/J. Kleer/F. Kley (Behrs Publishing), 1st Edition 2007
• Information Sheet "Safely Catered - Particularly Sensitive Population Groups in Community Facilities", Federal Institute for Risk Assessment, Berlin 2017

Profile on "Enterobacteria"

General Information

Most enterobacteria (Enterobacteriaceae) are widespread in our environment and are considered general hygiene indicator organisms in many foods. Furthermore, their presence in large numbers can lead to spoilage in food. However, within this family of bacteria, there are also important pathogens such as Salmonella, Yersinia enterocolitica, Shigella, and pathogenic Escherichia coli strains. Therefore, this family of bacteria plays a very important role in food hygiene.

Origin

Many representatives of enterobacteria are regularly detected in soil, water, and on plants. Moreover, these bacteria are found in the intestines of humans and animals. Overall, enterobacteria are widely distributed in our environment.

Significance

Due to the wide distribution of this family of bacteria in our environment, a certain number of enterobacteria is tolerated depending on the food. However, certain values should not be exceeded, as elevated levels of enterobacteria indicate manufacturing errors. Such cases are usually referred to as hygiene errors, but the causes can be diverse depending on the food (see following paragraph).

Elevated numbers can lead to sensory deviations and, in the case of official samples, to objections. Although there are pathogens such as Salmonella among the Enterobacteriaceae, in most foods elevated levels of enterobacteria do not indicate a health risk for the consumer.

Important Causes of Elevated Numbers

• Hygiene errors during production (e.g., contaminated work items, surfaces, and equipment, inadequate personal hygiene,...)
• Microbially contaminated raw materials
• Cross-contamination between raw and processed foods
• Insufficient refrigeration and/or prolonged storage of foods (exceeding the shelf life)
• Inadequate heating of the food

Growth Conditions

• Temperature: Growth at min. 0 °C
• pH value: Growth at min. 4.4
• aw value: Growth up to min. 0.95
• Oxygen requirement: Facultatively anaerobic

At What Temperatures Do These Microorganisms Die?

In general, it can be assumed that these bacteria are killed when heated to +72 °C for at least two minutes or through an equivalent process. In foods, it is important to ensure that this temperature-time combination is reached in the core of the product to effectively kill the bacteria.

Further Information and Literature

• www.bfr.bund.de: under "Food Safety"
• www.lgl.bayern.de: under "Food" and then "Hygiene"
• Food Microbiology, J. Krämer and A. Prange, 7th edition 2017
• Microorganisms in Foods, H. Keweloh, 2nd edition 2008
• Information sheet "Safely Catered - Particularly Vulnerable Groups in Community Facilities", Federal Institute for Risk Assessment, Berlin 2017

Profile "Listeria monocytogenes"

General Information and Origin

Listeria monocytogenes is increasingly playing an important role as a pathogen because the reported number of cases is continuously rising.

Although Listeria are primarily soil dwellers, these bacteria are widespread in the environment. Listeria can be found on plants, in sewage, and in the feces of healthy and diseased animals. Due to their widespread nature, Listeria are regularly found in raw animal and plant-based foods (e.g., meat, poultry, milk, vegetables, fish, and seafood). However, they also play a significant role in processed foods (e.g., meat and sausage products, smoked fish products, mixed salads).

Despite comprehensive hygiene measures in food operations, they can establish themselves in certain ecological niches and persist there. They are often found in moist areas in slimy coatings or biofilms.

Significance

These bacteria can cause very severe illnesses, especially in pregnant women, infants, elderly, and sick individuals. The proportion of deaths that occur in these individuals is relatively high.

Such cases can be avoided by sufficient heating of food and comprehensive hygiene during production. However, it should be noted that Listeria monocytogenes can still multiply at refrigerator temperatures. Short storage times and low temperatures < +2 °C are necessary to prevent the growth of these bacteria.

Important Causes of Elevated Germ Counts

• Hygiene errors during production (e.g., contaminated work tools, surfaces, and equipment) and biofilm formation in hard-to-reach areas
• Cross-contamination between raw and processed foods
• Processing of contaminated raw materials
• Insufficient cooling and/or overstocking of foods
• Inadequate heating of food

Growth Conditions

• Temperature: Growth at 0 - 45 °C
• pH: Growth at 4.5 - 9.0
• aw-value: Growth down to min. 0.93
• Salt tolerance: max. 10%
• Oxygen requirement: facultative anaerobic, reproduction in vacuum packaging and modified atmosphere packaging possible

At what temperatures do these microorganisms die?

Generally, it can be assumed that these bacteria are killed by heating to +72 °C for at least two minutes or by an equally effective process. In foods, it should be noted that this temperature-time combination must be reached in the core of the product to reliably kill the bacteria.

Further Information and Literature

• www.rki.de: under "Infectious Diseases A-Z"
• www.bfr.bund.de: under "Food Safety"
• www.lgl.bayern.de: under "Food" and then "Hygiene"
• Food Microbiology, J. Krämer and A. Prange, 7th edition 2017
• Microorganisms in Food, H. Keweloh, 2nd edition 2008
• Handbook of Food Hygiene, K. Fehlhaber/J. Kleer/F. Kley (Behrs Verlag), 1st edition 2007

Gluten is a naturally occurring protein mixture found in many cereals. For people with gluten intolerance, consumption can have harmful health effects. Information about the absence or reduced presence of gluten in food is regulated by Implementing Regulation (EU) No 828/2014. Gluten and cereals containing gluten are also mandatory declaration substances according to Annex II of Regulation (EC) No 1169/2011 (allergen labeling).

Profile of “aerobic mesophilic colony count”

General Information

The aerobic mesophilic colony count is often referred to as the "total colony count." It provides information about the number of microorganisms (bacteria, yeasts, and molds) that optimally multiply under aerobic conditions in a temperature range between 30 °C and 40 °C.

Origin

Since the aerobic mesophilic colony count includes a large number of microorganisms (such as Enterobacteriaceae, Pseudomonads, Bacillus, Staphylococci, Listeria, yeasts, and molds…), this parameter cannot be attributed to a specific origin. They can be found virtually everywhere: e.g., raw materials, humans, animals, plants, soil, water, air, as well as work surfaces and equipment.

Significance

Aerobic mesophilic microorganisms are found in or on almost all foods (an exception is sterilized foods like canned goods). Depending on the product, a certain number of aerobic mesophilic microorganisms is normal and unavoidable. However, if these values are exceeded, it indicates errors.

An elevated aerobic mesophilic colony count is often regarded as an indicator of hygiene and/or spoilage. Depending on the food and colony count, elevated counts can lead to sensory deviations and objections.

Important causes for elevated counts

• Hygiene errors during production (e.g., contaminated work items, surfaces, and equipment, inadequate personal hygiene…)
• Cross-contamination between raw and processed foods
• Microbially contaminated raw materials
• Insufficient cooling and/or prolonged storage of foods (exceeding the shelf life)
• Insufficient heating of foods or too low and prolonged holding temperatures

At what temperatures do these microorganisms die?

In general, it can be assumed that most bacteria are killed when heated to +72 °C for at least two minutes or by an equally effective process. In foods, it is important to ensure that this temperature-time combination is reached at the core of the product to safely kill the bacteria.

However, bacterial spores are particularly heat-resistant and can survive these temperatures. Relevant bacteria in foods that form spores include Bacillus cereus, Clostridium perfringens, and Clostridium botulinum.

Further Information and Literature

• www.lgl.bayern.de: under "Food" and then "Hygiene"
• Leaflet “Safely catered – Particularly sensitive groups of people in communal facilities”, Federal Institute for Risk Assessment, Berlin 2017
• Food Microbiology, J. Krämer and A. Prange, 7th Edition 2017
• Microorganisms in Foods, H. Keweloh, 2nd Edition 2008

Fact sheet on "Yeasts"

General Information and Origin

Yeasts are widespread in our environment (plants, humans, soil, air...) and therefore are part of the "normal" microflora in many foods. Plant-based foods such as fruits, as well as other foods with low water content and/or low pH, are particularly at risk of spoilage by yeasts.

Yeasts are also intentionally used in the production of several foodstuffs. These include, for example, alcoholic beverages and baked goods.

Significance

A certain number of yeasts is tolerated in most food groups. However, if these levels are exceeded, it indicates hygiene deficiencies as well as possible premature spoilage of the food (exceptions are foods in which culture yeasts are deliberately used during production).

Yeasts can grow even in the absence of oxygen, producing ethanol. Unlike most bacteria, yeasts have the special ability to grow at low water contents and/or low pH-values.

Particularly in foods with a lowered pH, such as delicatessen products, cheeses and cheese products, and fruit juices, as well as foods with low water content such as fruit concentrates, yeasts are feared spoilage agents as they can lead to sensory changes.

Key Causes for Excessive Numbers

• Hygiene errors during production (e.g., contaminated work tools, surfaces, and equipment, inadequate personal hygiene,...)
• Processing of contaminated raw materials
• Cross-contamination between raw and processed foods
• Errors in storage (excessive temperatures, too long storage duration...)
• High number of yeasts in ambient air
• Insufficient heating of food

Growth Conditions

• Temperature: Growth at 0 - 40°C
• pH: Growth at 1.5 – 8.5
• aw-value: Growth down to min. 0.80
• Oxygen Requirement: Facultatively anaerobic

At what temperatures do these microorganisms die?

In general, it can be assumed that yeasts are killed when heated to +72°C for at least two minutes or by an equally effective process. In foods, it should be noted that this temperature-time combination must be reached in the core of the product to ensure the bacteria are safely killed.

Further Information and Literature

• www.lgl.bayern.de: under "Food" and then "Hygiene"
• Pathogenic Microorganisms: Yeasts, B. Fiedler (Behr’s Verlag), 2nd edition 2014
• Food Microbiology, J. Krämer and A. Prange, 7th edition 2017
• Microorganisms in Foods, H. Keweloh, 1st edition 2009
• Leaflet "Safely Catered – Particularly Sensitive Population Groups in Community Facilities", German Federal Institute for Risk Assessment, Berlin 2017

Profile on “Hepatitis A”

General Information and Origin

An infection with the worldwide prevalent Hepatitis A virus (HAV) is associated with abdominal, joint, and limb pain, flu-like symptoms, vomiting, nausea, and acute liver inflammation (jaundice). In countries with low hygiene standards, the infection rate is already very high in childhood. In Europe and North America, Hepatitis A infections are now mainly travel-associated, which has led to a continuous decline in the frequency of infections in recent decades.

Importance

Humans are the main host and probably the only reservoir of Hepatitis A viruses. These are excreted with the stool 1 to 2 weeks before the onset of illness and are transmitted through direct contact or smear infections.

The viruses can also be transmitted through the consumption of contaminated food (e.g., shellfish, but also vegetables, salads, or fruits due to fertilization with feces or irrigation with fecally contaminated water) or contaminated (bathing) water. A characteristic of the virus is its high resistance to disinfectants, environmental influences, and heat. However, the number of foodborne Hepatitis A infections in Germany is very low and predominantly travel-associated.

Important Causes of Elevated Germ Counts

• Contamination of food by carriers
• Contamination of vegetables and other plant-based foods by fertilizers or irrigation with fecally contaminated water
• Processing of contaminated raw materials
• Contamination through contaminated drinking water

Growth Conditions

• Viruses can only multiply in living host cells
• Viruses can survive for several days in food and drinking water, but cannot multiply
• Viruses can remain infectious for extended periods at refrigerator and freezing temperatures (-18 °C)
• Susceptible to low pH values, drying, and heating

At What Temperatures Do These Microorganisms Die?

Heating to over 80 °C appears to be sufficient to inactivate even higher concentrations of the viruses within one minute. However, the information in the literature is not consistent, and further research is needed.

Further Information and Literature

• www.rki.de: under “Infectious Diseases A-Z”
• www.bfr.bund.de: under “Food Safety”
• Food Microbiology, J. Krämer and A. Prange, 7th Edition 2017
• Microorganisms in Food, H. Keweloh, 2nd Edition 2008

Fact Sheet on Legionella in Drinking Water

General Information and Origin

Legionella are environmental germs found worldwide. Naturally, they occur in small quantities in surface water and groundwater.

Especially in artificial water systems (e.g., water pipes in buildings), the pathogens find favorable growth conditions at certain temperatures. The multiplication of Legionella mainly occurs in sediments and deposits of the pipe system (biofilms). The presence of Legionella in artificial water systems is primarily influenced by the water temperature and the water's residence time. Especially poorly designed and inadequately maintained water systems are regularly affected by Legionella infestation.

Significance

Legionella cause various diseases in humans, such as flu-like symptoms or severe pneumonia, which can be fatal.

Legionellosis is primarily caused by inhaling atomized or aerosolized water. The pathogens spread through water droplets in the air and can thus be inhaled. Infection usually occurs through showers, whirlpools, humidifiers, faucets, or air conditioning systems. Human-to-human transmission is not possible.

Legal Regulations for Drinking Water

The Drinking Water Ordinance (TrinkwV 2001) prescribes regular testing for Legionella. This affects entrepreneurs and owners of drinking water installations with large systems for drinking water heating, if the water is commercially and/or publicly dispensed and there is also atomization of the water.

A large system refers to a storage drinking water heater or a central flow-through drinking water heater with a content of more than 400 liters or a content of more than three liters in at least one pipeline between the outlet of the drinking water heater and the withdrawal point.

The public dispensing concerns, for example, hospitals, schools, kindergartens, hotels, and nursing homes. These facilities are required to test for Legionella once a year. Likewise, owners/landlords of multi-family houses, housing associations, and property management companies are affected. For these, the required testing interval is three years.

The Drinking Water Ordinance stipulates a technical measure value of 100 colony-forming units (CFU) per 100 ml for Legionella. If this value is exceeded, it must be reported to the responsible health department.

If a company is not legally required to test for Legionella, an examination is still recommended as part of due diligence, especially if showers are present or there is contact with atomized or aerosolized water in other ways.

Important Causes for Elevated Germ Numbers

• Irregular use of water pipes
• Dead ends in the pipe system
• Insufficient regulator temperature on the drinking water heater
• Insufficient water temperatures in the pipe system

Growth Conditions

The optimal growth temperature for Legionella is between 25 - 45 °C.

At what temperatures do these microorganisms die?

At water temperatures above 55 °C, Legionella growth is inhibited. Above 60 °C, Legionella are generally killed.

To protect against Legionella infestation, the water should leave the hot water storage tank at a minimum of 60 °C and return to the storage tank at a minimum of 55 °C. The maximum temperature drop in the pipe system should not exceed five degrees. Water should also not stagnate in the pipes for more than 72 hours.

Further Information and Literature

• www.rki.de: under "Infectious Diseases A-Z"
• UBA recommendation "Systematic Testing of Drinking Water Installations for Legionella According to Drinking Water Ordinance - Sampling, Investigation Procedure, and Indication of Results" from December 18, 2018
• Drinking Water Ordinance - TrinkwV 2001
• www.umweltbundesamt.de under Topics: Drinking Water

Fact Sheet on "Bacillus spp."

General Information and Origin

• Gram-positive, mostly motile rod-shaped bacteria
• Aerobic or facultatively anaerobic growth
• Widespread in the environment, preferably in soil/dust
• Very resistant to environmental influences
• Characteristic is the formation of endospores

Significance in Cosmetics and Pharmaceuticals

Bacillus spp. are capable of forming resistant forms, known as spores. These are very heat stable and can withstand heating steps. Furthermore, these bacteria can partially produce heat-stable toxins that are very resistant and can cause poisoning with vomiting and/or diarrhea. This can lead to critical situations, especially in the food sector.

In the cosmetic or pharmaceutical sector, Bacillus spp. are generally considered uncritical because the number of vegetative cells in a contaminated product usually remains stable and multiplication throughout the products' lifecycle is rather unlikely.

The spores of Bacillus spp. often survive the production process due to their mentioned heat stability. Since they are neither considered "specified microorganisms," which should not be detectable in 1g of product, nor classic spoilage organisms in cosmetic products, germ counts below the threshold value are generally considered uncritical. The cause of contamination is often found in contaminated raw materials or insufficient equipment hygiene. As Bacillus spp. are spore-formers, equipment cleaning and disinfection are particularly crucial. If cleaning and disinfection, especially regarding the mentioned spores, are inadequate, they can remain in the system and multiply. When favorable growth conditions occur, the transition from spores to the vegetative reproductive form is possible.

Major Causes of Contaminations

• Use of contaminated raw materials (often unevenly distributed in powders)
• Environment (air, packaging, etc.)
• Insufficient cleaning and disinfection, e.g.
  • of manufacturing equipment (plants and devices)

Important Measures

• Selection of reliable raw material suppliers and microbiological examination of raw materials
• Proper cleaning and disinfection of manufacturing equipment (plants and devices)
• Cleansers and disinfectants must also be capable of removing spores
• Good operational hygiene

Interesting link: https://www.bav-institut.de/de/newsletter/Special Issue Pharmaceuticals No. 2: Assessment of Critical Microorganisms in Non-Sterile Pharmaceutical Products Part 2

Profile of Pseudomonas aeruginosa

General Information and Origin

• belong to the family of Pseudomonads
• gram-negative, motile rods
• obligate aerobe
• widespread soil and water germ
• pathogenic for humans and animals

Significance in the Cosmetic and Pharmaceutical Field

Due to its pathogenic properties (e.g. causing purulent infections), the guideline for Cosmetic Products – Microbiology – Microbiological Limits (DIN EN ISO 17516) requires that Pseudomonas aeruginosa must not be detectable in 1g of product.

An important characteristic of Pseudomonas aeruginosa is its extreme indifference to external living conditions. Pseudomonas aeruginosa can survive for long periods in both moist and dry environments. In cosmetic and pharmaceutical manufacturing plants, pseudomonads can be found anywhere where sufficient water is present (washrooms, pipelines and equipment with residual moisture, water system, etc.). They can adapt to the environment and thus resist preservation and disinfection.

A particularly critical aspect of this microorganism, besides its resilience and ability to survive under unfavorable environmental conditions, is that it is often found in biofilms. Detachment of individual parts of the biofilm, which then irregularly enter the product, makes it particularly difficult to safely and reliably detect the microorganism during the finished product release inspection.

Even with small quantities of this bacterium in the product, it is important to monitor further development, as in many cases there can be a delayed increase in germ numbers.

Important Causes of Contamination:

• insufficient cleaning and disinfection, e.g.
  • of the water treatment system
  • of the water pipe system
  • of the manufacturing equipment (plants and devices)
• poor plant design, e.g.
  • residual water in plants and pipes
  • dead spots
  • incomplete cleaning and disinfection

⇒ The consequence of poor plant design and/or errors in cleaning and disinfection is usually biofilm formation in the water system or in plant parts, especially in pipelines, seals, valves, etc.

In the form of biofilms, Pseudomonas aeruginosa is largely protected against:

• high temperatures
• pH-value fluctuations
• chemical disinfectants
• UV radiation

Important Preventive Measures

• Proper design and cleaning and disinfection of the water system. In particular, biofilm formation must be avoided, as removing an existing biofilm is usually very difficult.
• Correct cleaning and disinfection of manufacturing equipment (plants and devices)
• Good operational and personnel hygiene

For more interesting information about this microorganism, please refer to the following publications:

www.wissenschaft.de

www.ecv.de

Profile of "Pluralibacter gergoviae" (formerly Enterobacter gergoviae)

General Information and Origin

• belong to the family of Enterobacteriaceae
• gram-negative rods
• facultative anaerobes
• widely distributed in the environment, e.g., in the intestines of humans and animals, on plants, and in water
• facultatively pathogenic germs, partially with antibiotic resistances

Importance in the Cosmetics and Pharmaceutical Sector

The number of recall notifications in recent years due to Pluralibacter gergoviae in cosmetics is increasing. Affected products are often baby shampoo, baby cream, shower gel, toothpaste, etc.

In a recent statement from the BfR in 2020, it is required that all cosmetic products must be fundamentally free of P. gergoviae. This must be demonstrated through appropriate investigations.

For example, although shower gel is quickly rinsed off, contact with mucous membranes or open wounds cannot be excluded. There is thus a risk that the microorganisms could enter the bloodstream.

Pluralibacter gergoviae is known for the so-called "Phoenix effect," in which a contamination believed to be gone reappears after some time, usually in very high numbers. Pluralibacter gergoviae can adapt to preservatives, meaning it can acquire but also lose certain properties. The entry into the product usually occurs through water used as a raw material. However, poor system hygiene also plays a major role. The germ frequently occurs in biofilms.

Important Causes of Contaminations

• insufficient cleaning and disinfection, e.g.,
  • of the water treatment plant
  • of the water piping system
  • of the manufacturing equipment (systems and devices)
• poor system design, e.g.,
  • residual water in systems and pipes
  • dead spots
  • incomplete cleaning and disinfection

⇒ The consequence of inadequate system design and/or errors in cleaning and disinfection is usually biofilm formation in the water system or system parts, especially pipes, seals, valves....

In biofilms, Pluralibacter gergoviae is largely protected from:

• high temperatures
• pH value fluctuations
• chemical disinfectants
• UV radiation

Important Measures

• proper design as well as cleaning and disinfection of the water system. In particular, biofilm formation must be avoided, as the removal of an existing biofilm is usually very difficult
• correct cleaning and disinfection of the manufacturing equipment (systems and devices)
• good operational and personal hygiene

The BfR statement titled "Skin creams, make-up, and shampoos should be free of Pluralibacter gergoviae" can be found here:

www.bfr.bund.de

Escherichia coli

General Information and Origin

• belongs to the family of Enterobacteriaceae

• gram-negative, acid-forming, flagellated rods

• part of the natural intestinal flora of humans and animals

• there, producer of vitamins and part of the immune defense

• some species pathogenic toxin producers

Significance in the Cosmetic and Pharmaceutical Industry

Escherichia coli (E. coli) is one of the most well-researched microorganisms and holds significant importance in the food industry, in addition to cosmetics. It is considered a model organism for the entire family of Enterobacteriaceae. Although detection in cosmetic settings is extremely rare, its absence in 1g of product is required by DIN EN ISO 17516 (microbiological limits for cosmetic products). It serves here as an indicator for hygiene-related contamination. In preservation stress tests for cosmetics, E. coli is included as one of a total of five test organisms and as a representative of enterobacteria.

In the pharmaceutical industry, it is a lead germ for all products for oral use, whose exclusion is required in non-plant products. However, even in plant-based products, which usually have quite high microbiological limits, E. coli is relatively strictly regulated.

Important Causes of Contamination

The microorganism is multifaceted, and so are the causes for product contamination. As a natural inhabitant of plants, a possible entry path is the use of non-sterile raw materials. At the same time, as a typical intestinal resident, it can also be an indicator of poor hygiene. In this case, production water or humans are often cited as the cause.

Important Preventive Measures

The occurrence of these bacteria can be significantly reduced by appropriate hygiene measures. Due to the fact that pathogenic E. coli strains exist, which can cause severe poisoning symptoms, reduction and killing are usually indispensable (for oral intake). For cutaneous intake, E. coli plays only a very minor role.

The germ is relatively sensitive to higher temperatures. The so-called D65 value for E. coli is 0.1 minutes (reduction of the germ count by at least 90% in 0.1 minutes). Therefore, thermal treatment of a contaminated product is a suitable measure for germ reduction. Furthermore, a number of well-known disinfectants and preservatives are effective against the growth of E. coli.

The most important measure, however, remains preventing contamination through appropriate operational and personal hygiene.

Literature

www.bav-institut.de

www.bfr.bund.de

Profile of "Acetic Acid Bacteria"

General Information and Origin

• also called Acetobacteriaceae
• gram-negative rods
• oxidize ethanol to acetic acid
• tolerate low pH values
• found in foods containing sugar
• in plant raw materials (e.g., fruits)

Importance in the Cosmetics and Pharmaceutical Sector

Acetic acid bacteria lead to microbial spoilage of the product through their breakdown of ethanol to acetic acid. This usually results in less health impairment and more sensory changes. The product becomes more acidic due to the formed acetic acid, and the smell changes towards acetic acid. In the food sector, acetic acid bacteria are typical spoilage organisms that are very frequently found.

Important Causes of Contamination

Causes are often the use of raw materials contaminated with acetic acid bacteria. Another possibility is introduction from the environment, as they can be easily transported through the air from contaminated areas. However, acetic acid bacteria can also indicate weaknesses in operational hygiene. For example, they can grow in product residues in pipelines and can be flushed out at various times, contaminating further or later products.

Important Measures

One of the most important measures to prevent contamination of cosmetics with acetic acid bacteria is the appropriate selection and examination of the raw materials used. Since acetic acid bacteria grow particularly well in acidic conditions, reducing pH levels is not a suitable method of control. In contrast, thermal treatment is possible, as the microorganisms are relatively sensitive to temperature. Literature reports a decimal reduction time of 0.09 – 0.14 minutes at 60°C and 1.20 - 1.30 minutes at 54°C [1].

Examination for Acetic Acid Bacteria

To determine acetic acid bacteria, determining the total microbial count using CASO medium is often not sufficient, as they do not grow well on this universal medium. They are often found in routine testing on the medium used for yeast and mold determination, as it has a lower pH value and the incubation time is longer (acetic acid bacteria only form very small colonies that grow very slowly). If acetic acid bacteria are suspected, a targeted examination for this type of microorganism is suggested. For this, orange-fruit juice agar is used as a nutrient medium based on a method derived from the food sector.

Bibliography

[1] G. Rachon, C.J. Rice, K. Pawlowsky, C.P. Raleigh: Challenging the assumptions around the pasteurization requirements of beer spoilage bacteria, J. Inst. Brew. 2018

Profile on "Burkholderia spp."

General Information and Origin

• belong to the family Burkholderiaceae
• gram-negative motile rods
• obligately aerobic
• widely distributed in the environment, preferably in water
• facultatively pathogenic for humans, animals, and plants

Importance in the Cosmetic and Pharmaceutical Sector

Burkholderia species are found in water. They are undemanding, resilient, and survive in purified water and disinfectant solutions containing quaternary ammonium compounds, hexachlorophene, or chlorhexidine. In water-rich cosmetics and pharmaceuticals, Burkholderia can potentially multiply significantly.

A large portion of all recalls of the aforementioned products is due to Burkholderia cepacia. Affected products included baby wipes, nasal sprays, and mouth rinses. In most cases, contaminated water was identified as the main cause.

A critical aspect of this microorganism, in addition to its resilience and ability to survive unfavorable environmental conditions, is that it frequently occurs in biofilms. Detachment of individual parts of the biofilm, which then irregularly disperse into the product, makes it particularly difficult to detect the microorganism during finished product release testing.

Even if Burkholderia is detected only in small amounts, it is important to examine this contamination more closely and monitor further development, as in many cases there may be a delayed increase in germ numbers.

Major Causes of Contamination

• insufficient cleaning and disinfection, e.g.
  • of the water treatment plant
  • of the water piping system
  • of the manufacturing equipment (facilities and devices)
• poor equipment design, e.g.
  • residual water in facilities and pipes
  • dead-ends
  • incomplete cleaning and disinfection

⇒ The consequence of poor equipment design and/or errors in cleaning and disinfection is usually the formation of biofilms in the water system or in parts of the equipment, especially pipelines, seals, valves….

In biofilms, Burkholderia spp. is largely protected from:

• high temperatures
• pH fluctuations
• chemical disinfectants
• UV radiation

Important Measures

• proper design as well as cleaning and disinfection of the water system. In particular, biofilm formation must be avoided, as removing an existing biofilm is usually very difficult
• correct cleaning and disinfection of the manufacturing equipment (facilities and devices)
• good operational and personal hygiene

Interesting link: www.deutsche-apotheker-zeitung.de