Microbiological Testing

The labo­ra­tory network of the Tentamus Group offers its customers the following services in the industry of microbiology:

• Micro­bi­o­log­ical testing in accor­dance with Regu­la­tion (EC) No. 2073
• Deter­mi­na­tion of the micro­bi­o­log­ical status of food, as well as detec­tion of path­o­genic germs such as Salmo­nella, Listeria mono­cy­to­genes and Campy­lobacter
• Rapid methods (Vidas) for Salmo­nella and Listeria mono­cy­to­genes
  Perfor­mance of follow-up tests to deter­mine or check compli­ance with the best-before date (BBD) or the use-by date
• Micro­bi­o­log­ical incoming goods inspec­tions for animal or plant raw mate­rials or semi-finished products
• Micro­bi­o­log­ical inspec­tion of the cleaning and disin­fec­tion status of equip­ment and surfaces
• Sampling and testing of drinking water in accor­dance with the Drinking Water Ordi­nance for e.g. Legionella, Escherichia coli and Pseudomonas aerug­i­nosa
• Micro­bi­o­log­ical exam­i­na­tion of cooling tower water
• Pest infes­ta­tion of dried fruits and nuts
• Veri­fi­ca­tion of the desig­nated trade classes for fresh and frozen poultry and eggs
• Testing of eggs for fresh­ness by means of air chamber height, yolk index and Haugh units
• Micro­bi­o­log­ical cosmetic testing according to ISO methods and the Euro­pean Pharmacopoeia
• Preser­va­tion stress tests
• Testing of non-sterile phar­ma­ceu­ti­cals according to Euro­pean Phar­ma­copoeia and GMP regulations
• Antibac­te­rial activity of honey
• Testing of living biotherapeutics
• Pyrogen deter­mi­na­tions
• Deter­mi­na­tion of genotoxicity
• Purity testing of bacte­rial cell banks

Strict regu­la­tory require­ments are set for drinking water not only with regard to substance-related limit values such as nitrate, nitrite, fluo­ride or lead, but also with regard to microor­gan­isms. For example, the Infec­tion Protec­tion Act and the Drinking Water Ordi­nance stip­u­late that drinking water ​“must not contain any pathogens in concen­tra­tions that could endanger human health.”

In routine drinking water moni­toring by micro­bi­o­log­ical labo­ra­to­ries, evidence is there­fore provided by so-called ​“indi­cator organ­isms” for fecal cont­a­m­i­na­tion, such as Escherichia coli or ente­ro­cocci, in the water sample.

If these numer­i­cally very common germs cannot be detected in a sample, it can be assumed that the less common but poten­tially more dangerous microor­gan­isms are also not present in the sample.

Drinking water testing for legionella

In addi­tion to micro­bi­o­log­ical testing for fecal cont­a­m­i­na­tion, testing for Legionella is another focus of drinking water analysis and moni­toring. Legionella is a consid­er­able health hazard, espe­cially for immuno­com­pro­mised persons. The disease caused (“Legion­naires’ disease”, legionel­losis) can be fatal.

Legionella are trans­mitted by droplets. Infec­tion occurs when they are inhaled in high numbers, e.g. through water vapor. Micro­bi­o­log­ical testing for Legionella is there­fore required by law for the drinking water instal­la­tions of many facil­i­ties. These include facil­i­ties that operate a large-scale system for heating drinking water, dispense drinking water as part of commer­cial or public activ­i­ties, and where there are showers or other facil­i­ties for misting water. Such facil­i­ties include, but are not limited to, resi­dences, hospi­tals, swim­ming pools, schools, and hotels.

However, oper­a­tors of cooling towers, evap­o­ra­tive cooling systems and wet sepa­ra­tors are also subject to exten­sive noti­fi­ca­tion and moni­toring oblig­a­tions with regard to legionella in order to operate their facilities.

Cosmetic prod­ucts must be safe and harm­less to health from the time they are placed on the market until they are used by the customer. The Euro­pean Cosmetics Regu­la­tion VO (EG) 1223/2009 sets the legal frame­work for this. This health safety also includes the micro­bi­o­log­ical quality of a product. ISO 17516, the state of the art, spec­i­fies limit values for this.

In order to main­tain suffi­cient micro­bi­o­log­ical product quality, it is neces­sary to estab­lish a so-called micro­bi­o­log­ical quality manage­ment (MQM) in the plants. Compo­nents of a MQM are the indus­tries research & devel­op­ment, indus­trial hygiene as well as quality control (QC).

Micro­bi­o­log­ical tests are required in all indus­tries. These include:

• Control of the micro­bi­o­log­ical status
  • Exam­i­na­tions according to ISO standards
  • Exam­i­na­tion by rapid method: results aerobic microor­gan­isms and yeasts/​molds within 3 days
  • Total number of aerobic microorganisms/​g
  • total number of yeasts and molds/​g
  • spec­i­fied microor­gan­isms (P. aerug­i­nosa, E. coli, S. aureus, C. albi­cans) in 1 g
  • non-spec­i­fied microor­gan­isms such as Plural­ibacter gergoviae, Burk­holderia cepacia etc.
• Preser­va­tion load tests
  • DIN EN ISO 11930
  • Method of the Euro­pean Phar­ma­copoeia (Ph.Eur.5.1.3)
  • Method of the Amer­ican Phar­ma­copoeia (USP)
  • Customized spec­i­fi­ca­tions and microorganisms
  • Repet­i­tive expo­sure tests (multiple inoculations)
• Iden­ti­fi­ca­tions
  by MALDI-TOF within 24h
• Indus­trial hygiene
  • Exam­i­na­tion of swab samples and swab samples
  • Testing of micro­bi­o­log­ical quality of air
  • Testing of water quality

Rapid methods:

Some Tentamus Group labo­ra­to­ries also offer special rapid methods to provide customers with test results after 3 days. This includes:

• Testing for Salmo­nella, STEC/VTEC/EHEC using ​“real-time PCR”
• Testing for Listeria mono­cy­to­genes using a rapid cultural method
• Germ iden­ti­fi­ca­tion by mass spec­trom­etry (MALDI-TOF)

Phar­ma­ceu­ti­cals are subject to strict national and inter­na­tional regu­la­tions. Through our highly special­ized phar­ma­ceu­tical labo­ra­to­ries and scien­tists, we can opti­mally support you in the analysis of your pharmaceuticals.

Micro­bi­ology for phar­ma­ceu­ti­cals includes the detec­tion of microor­gan­isms that may be present in raw mate­rials, the produc­tion envi­ron­ment as well as in formu­lated prod­ucts. Our phar­ma­ceu­tical labo­ra­to­ries offer the full range of services, including testing of non-sterile prod­ucts and substances:

• Micro­bial limit testing
• Micro­bial cont­a­m­i­na­tion (bioburden analysis)
• Sterility testing
• Deter­mi­na­tion of biolog­ical load (Ph. Eur. 2.6.12, ISO 11737 – 1)
• Pyrogen deter­mi­na­tion: bacte­rial endo­toxin test (Ph. Eur. 2.6.14) and mono­cyte acti­va­tion test (Ph. Eur. 2.6.30)
• Micro­bi­o­log­ical testing of live biother­a­peu­tics (Ph. Eur. 2.6.36, Ph. Eur. 2.6.38)
• Purity testing of bacte­rial cell banks
• Bacte­rio­phage analysis
• Deter­mi­na­tion of geno­tox­i­city (AMES test, OECD TG 471)
• Micro­bi­o­log­ical testing of cosmetics according to CTFA or ISO standards

Sampling is an essen­tial and crit­ical step that has a deci­sive influ­ence on the signif­i­cance of the results of the micro­bi­o­log­ical exam­i­na­tion. Errors in sampling can seri­ously reduce the signif­i­cance of the micro­bi­o­log­ical exam­i­na­tion, so that the purpose of the exam­i­na­tion cannot be fulfilled. There­fore, sampling should only be performed by trained personnel. Another crit­ical point is the controlled and timely trans­port of the collected sample for analysis to the contracted laboratory.

In addi­tion to the exam­i­na­tion of the total bacte­rial count, the range of services offered by our labo­ra­to­ries includes micro­bi­o­log­ical exam­i­na­tions and detec­tion methods for the following germs and pathogens:

• Aerobic mesophilic spore formers
• Bacillus cereus
• Campy­lobacter
• Candida albi­cans
• Clostridium perfrin­gens
• Coliform germs
• E.coli
• Enter­obac­te­ri­aceae
• Bile salt toler­ating gram-nega­tive bacteria
• Yeasts and molds
• Coag­u­lase-postitve staphylococci
• Legionella
• Listeria mono­cy­to­genes
• Lactic acid bacteria
• Pseudomonas spp.
• Salmo­nella spp.
• Shigella spp.
• Sulfite-reducing Clostridia and their spores
• Staphy­lo­cocci, entero­toxin, enterococci
• Staphy­lo­coccus aureus

Deter­mi­na­tion of the total bacte­rial count

Aerobic mesophilic germs include many different microor­gan­isms of various origins. A small number of aerobic mesophilic germs is normal on almost all foods. However, if the total plate count is elevated in the tested sample, this may indi­cate a hygiene defi­ciency in the produc­tion or processing process or may be consid­ered a spoilage indi­cator. Thus, the total plate count deter­mined in the micro­bi­ology labo­ra­tory allows conclu­sions to be drawn about the quality and safety of the tested product.

Detec­tion of yeasts and molds

Yeasts and molds are typical spoilage pathogens whose demands on your envi­ron­ment differ from those of most microbes. Yeasts and molds also grow under lower temper­a­tures or in envi­ron­ments with a lower water activity value (aW value), a measure of the avail­able water in a food. Molds are of partic­ular health concern because of the myco­toxins they produce, which can cause aller­gies and some of which are carcinogenic.

Detec­tion of coliforms

Coliform germs, which include the genera Escherichia, Citrobacter and Kleb­siella, are an impor­tant hygiene indi­cator for drinking water and food. The pres­ence of coliform germs in a sample is a typical indi­cator of poor hygiene.

Pathogens of food poisoning and food­borne illnesses

Clostridium perfrigens, Bacillus cereus, Staphy­lo­coccus aureus and Shigella can cause severe food poisoning (also known as food intox­i­ca­tion) through the toxins they produce, which are usually mani­fested by the symp­toms of vomiting and diar­rhea within a few hours of ingestion.

In contrast, Salmo­nella spp. or Listeria mono­cy­to­genes, for example, can cause food infec­tions, whereby the bacteria ingested through cont­a­m­i­nated food multiply in the intes­tine and, after a specific incu­ba­tion period of usually a few days, trigger symp­toms such as abdom­inal pain, diar­rhea, and vomiting, often in conjunc­tion with fever, which can lead to severe courses of illness in certain patient groups (including the elderly and patients with weak­ened immune systems).

Inoc­u­la­tion tests, so-called chal­lenge tests, can be used to simu­late the growth behavior of Listeria mono­cy­to­genes in a product and thus deter­mine the growth poten­tial of this highly path­o­genic germ in the product under inves­ti­ga­tion. These tests are neces­sary to meet regu­la­tory require­ments for product safety with respect to Listeria monocytogenes.

The following labo­ra­to­ries from the Tentamus Group offer micro­bi­o­log­ical testing: