Microbiology
Recommendations include e.g. mozzarella, brined cheese, raw meat, meat products, casings, fish and fish products, soft and shellfish, instant and dried products, ready meals, prepared dishes, delicatessen products, cereal products, bread, bakery and pastry goods, pasta, dried fruits, oilseeds, nuts, mixed salads, fruit salads, herbs and spices, ice cream and chocolate.
Microbiological criteria are included in several chapters of the Ph.Eur. Chapter 5.1.4 contains the acceptance criteria for non-sterile dosage forms (Table 1) as well as for raw materials used in their production (Table 2). Chapter 5.1.8 contains the acceptance criteria for herbal medicinal products for oral use.
Furthermore, many monographs of individual substances include specific acceptance criteria for microbiological quality.
Frequent detections occur, for example, in raw milk, fresh meat, spreadable raw sausage, soft cheese, leafy vegetables, and sprouts. Meat from ruminants and game is more frequently contaminated than pork.
Commonly contaminated are, for example, raw milk, raw milk cheese, semi-hard cheese, ready-to-eat sausages, pre-sliced cooked sausages, spreadable raw sausages, sliced packaged fruits or salads (ready-to-eat products), raw seafood, or smoked fish.
Certain toxin-producing strains of E.coli can cause diarrhea and more severe illnesses in humans, such as hemolytic uremic syndrome (HUS). Kidney failure and even death can result from this condition.
Listeria monocytogenes can easily overcome anatomical barriers in the body and, for example, penetrate the intestines, the blood-brain barrier, or the placenta without any problems.
For those affected by listeriosis, the disease is associated with a comparatively higher damage than with other foodborne infection pathogens (e.g., fever, muscle pain, gastrointestinal diseases, meningitis, sepsis). The mortality rate is about 10-20% for the general population and up to 75% for risk groups (pregnant women, newborns, young children, immunocompromised adults, those taking immunosuppressants or stomach acid inhibitors).
Since no minimum infectious dose can be determined for Salmonella, the absence of Salmonella is required in ready-to-eat foods. As a food safety criterion according to Annex I Chapter 1 of Regulation (EC) No. 2073/2005, the absence of Salmonella in 25g (or 10g) of food is always required. A quantitative determination is therefore not sufficiently informative for the microbiological assessment of foods.
The Regulation (EC) No. 2073/2005 on microbiological criteria for foodstuffs establishes sampling frequencies and microbiological limits (process hygiene and food safety criteria). It is directed at food business operators and sets the legal minimum requirements for the microbiological quality of certain foods. These include, for example, ready-to-eat meals, carcasses, meat preparations, milk and dairy products, egg products, and cut fruit and vegetables.
Biofilms are communities of bacteria, fungi, protozoa, or algae that attach to surfaces in aqueous systems, grow there, and form a slime layer. This layer usually consists of polysaccharides and protects the underlying microorganisms from influences such as disinfectants or high temperatures.
If you would like to learn more about biofilms, we recommend the following interesting information sources:
The German Society for Hygiene and Microbiology (DGHM e.V.) publishes microbiological reference and warning values, which provide an objective basis for businesses and authorities to assess the microbiological-hygienic status of a food product or a food group. DGHM recommendations exist for selected food groups. They are available for a fee at www.dghm-richt-warnwerte.de.
The European Pharmacopoeia specifies in the chapters describing the microbiological methods (2.6.12, 2.6.13, and 2.6.31) that the suitability of the test method for detecting microorganisms in the presence of the product must be demonstrated. This proof must be reconfirmed for all changes to the method or the product.
For this purpose, the product is inoculated with suspensions of the organisms mentioned in the aforementioned chapters, treated further as described there, and incubated on the mentioned media under the specified conditions.
In quantitative methods, the number for each reference microorganism may deviate by a maximum factor of 2 from the reference value, which was determined using the same methods in the absence of the product.
In qualitative methods, the growth of the reference microorganisms must be detectable as the result of the test in the absence of the product.
If the suitability of the method cannot be demonstrated using standard procedures, the method must be appropriately adjusted (for example, by higher product dilutions or by using a different diluent or other neutralizing substances).
In the European Pharmacopoeia (Ph.Eur.), the monograph 2153 defines excipient pellets for homeopathic preparations as solid preparations made from sucrose, lactose, or other suitable excipients.
These excipient pellets form the basis for the well-known globules. The Ph. Eur distinguishes between two different types of globules:
- Impregnated homeopathic pellets (Globuli – Granula homoeopathica imbuta) Ph.Eur. Monograph 2079
- Coated homeopathic pellets (Globuli velati – Granula homoeopathica velata) Ph.Eur. Monograph 2786
Impregnated homeopathic pellets are excipient variants impregnated with one or more liquid homeopathic preparations.
In contrast, the excipient pellets for coated homeopathic pellets are covered with a sucrose syrup in which the homeopathic preparations are contained (dissolved). Independently, other triturations (for example, mineral-effective substances with lactose powdered) can also be incorporated.
Both groups are intended for sublingual or oral use. Even though the water activity of both product groups is likely to be very low (low water content, high sugar content), the Ph.Eur. provides for a microbiological purity test for globules. The acceptance criteria are identical for the excipient pellets as well as for the two variants of globules.
The following acceptance criteria are required in the respective monographs.
- Total aerobic microbial count (according to Ph.Eur. 2.6.12): 102 CFU/g
- Total yeast and mold count (according to Ph.Eur. 2.6.12): 101 CFU/g
- Pseudomonas aeruginosa (according to Ph.Eur. 2.6.13): Absent
- Staphylococcus aureus (according to Ph.Eur. 2.6.13): Absent
Therefore, to comply with the Ph.Eur. requirements, globules also need a microbiological test. As a microbiological laboratory specialized in the testing of pharmaceuticals, the BAV Institute would be pleased to support you.
In the European Pharmacopoeia (Ph. Eur.), the monograph 2153 defines excipient-free pellets for homeopathic preparations as solid preparations made from sucrose, lactose, or other suitable excipients.
These excipient-free pellets form the basis for the well-known globules. The Ph. Eur. distinguishes between two different types of globules:
- Impregnated homeopathic pellets (Globules – Granula homoeopathica imbuta) Ph. Eur. Monograph 2079
- Coated homeopathic pellets (Globuli velati – Granula homoeopathica velata) Ph. Eur. Monograph 2786
The impregnated homeopathic pellets are the excipient-free variant, which are impregnated with one or more liquid homeopathic preparations.
In contrast, the excipient-free pellets in coated homeopathic globules are coated with a sucrose syrup in which the homeopathic preparations are contained (dissolved). Independently, other triturations (for example, mineral active substances triturated with milk sugar) can also be incorporated.
Both groups are common in that they are intended for sublingual or oral use. Even though the water activity of the two product groups is likely to be very low (low water content, high sugar content), the Ph. Eur. requires a microbiological quality control for globules. The acceptance criteria are identical for the excipient-free pellets and both variants of globules.
The following acceptance criteria are required in the respective monographs:
- Total aerobic microbial count (according to Ph. Eur. 2.6.12): 102 CFU/g
- Total yeast and mold count: (according to Ph. Eur. 2.6.12): 101 CFU/g
- Pseudomonas aeruginosa (according to Ph. Eur. 2.6.13): Absent
- Staphylococcus aureus (according to Ph. Eur. 2.6.13): Absent
In order to comply with the Ph. Eur. requirements, globules also require microbiological testing. As a microbiological laboratory specializing in the testing of pharmaceuticals, the BAV Institute can gladly assist you with this.
Annex I Chapter 1 of Regulation (EC) No. 2073/2005 sets criteria for pathogenic microorganisms that must not be exceeded. These criteria apply to products on the market, not at the manufacturing level.
The regulation focuses only on certain food groups.
Criteria exist for the following parameters:
- Listeria monocytogenes
- Salmonella
- Staphylococcal enterotoxin
- Cronobacter spp.
- E.coli
- STEC
- Histamine
Annex I Chapter 2 of Regulation (EC) No 2073/2005 establishes criteria to verify the implementation of good hygiene practices and the application of the principles of the HACCP concept. These criteria do not apply to products already on the market but exclusively at the manufacturer level.
Criteria are set for the following food categories:
- Carcasses
- Minced meat
- Mechanically separated meat
- Meat preparations
- Milk and dairy products
- Egg products
- Fishery products
- Vegetables, fruits, and products made from them
Zoogenic pathogens can cause diseases or infections that can be transmitted from animals to humans through direct or indirect contact as well as through food. These include various bacteria, viruses, fungi, and parasites. In Germany, the following pathogens are relevant, among others:
Salmonella, Campylobacter, verotoxin-producing E. coli (STEC/VTEC/EHEC), Yersinia enterocolitica, Listeria monocytogenes, methicillin-resistant Staphylococcus aureus (MRSA), rabies, Trichinella, toxoplasmosis.
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).