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Microbiological Analysis

We conduct standard-compliant microbiological analyses to detect, identify, and evaluate microorganisms in pharmaceuticals, food, water, and packaging materials – ensuring reliable results for quality, hygiene, and product safety.

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From Presumptive Detection to Species Identification –
Microbiological Safety Across the Production Lifecycle

Workers in protective clothing process large quantities of a white dairy product in an industrial food production facility.

Microbiological quality is a central aspect for customer safety, products shelf-life and regulatory conformity. Microbiological analyses are used to examine microorganisms in complex systems such as medical devices, foodstuffs, water, and production environments. They enable the assessment of microbial contamination, the verification of hygiene standards, and the assurance of regulatory compliance throughout the entire supply chain.

As an accredited testing laboratory, we conduct these tests in accordance with recognised standards and guidelines, providing reliable, valid, and comparable results for sound quality and safety decisions.

Parameter Portfolio

A structured set of microbiological parameter groups, each addressing a distinct analytical question and grouped by functional and regulatory relevance.

Pathogens

Detection of microorganisms relevant to public health for risk assessment and product safety. These are reliably detected in various matrices.

Methods include culture-based techniques up to molecular methods, such as PCR.

Typical organisms: Salmonella spp., Listeria monocytogenes, Staphylococcus aureus.

Microbiology in the Sectors Food, Beverage, Gourmet Food, Animal Feed

Assessment of quality, shelf-life and safety throughout the production chain. The analysis examines spoilage organisms, yeasts, moulds and pathogenic bacteria.

Methods combine traditional cultivation with molecular detection techniques.

Typical organisms: Bacillus spp., Listeria spp., Salmonella spp.

Hygiene Indicators

Assessment of the microbiological status of processes and environments. They serve as indicators of contamination and the effectiveness of cleaning.

Methods are predominantly based on culture and quantitative bacterial count determination.

Typical organisms: Escherichia coli, Enterococcus spp., Coliform bacteria.

Microbiology in the Sector Pharmaceuticals

Ensuring that products are sterile and microbiologically controlled. Tests cover from pharmaceutical products over raw materials to water (e.g., WFI).

Methods follow pharmacopoeial guidelines, such as sterility tests, endotoxin detection and identification techniques.

Typical organisms: Spore-forming bacteria, Staphylococcus aureus, Pseudomonas aeruginosa.

Water Testing

Analysis of microbiological parameters to ensure water quality. Analysis is conducted on samples, such as of drinking, cooling, and process water.

Methods include standard-based cultivation, filtration and selective detection procedures.

Typical organisms: Legionella pneumophila, Pseudomonas aeruginosa.

Food Contact Materials

Assessment of microbial contamination in packaging and materials that come into contact with food. Parameters include Bioburden and antimicrobial properties.

Methods include count reduction tests, sterility testing and validated microbiological test procedures.

Typical organisms: Environmental bacteria, spore-forming bacteria, biofilm-forming bacteria.

Analytical Scope

Specialised microbiological disciplines, each with dedicated methods, regulatory context and matrix expertise.
Select a discipline for full parameter lists and method details.

Pathogens

Detection and confirmation of foodborne pathogens per Regulation (EC) No 2073/2005 – Salmonella, Listeria, Campylobacter, STEC and more.

Spoilage Organisms

Quantification and identification of yeasts, moulds, lactic acid bacteria and spoilage-specific flora for shelflife and stability assessment.

Hygiene Indicators

Enterobacteriaceae, E. coli, coliforms, TVC – process hygiene verification and raw material quality assessment per EU criteria.

Spores & Spore Formers

Heat-resistant endospore enumeration and toxigenic spore-former detection for thermally processed and shelf-stable products.

Microbial Identification

Species-level identification by MALDITOF MS and molecular sequencing for contamination source tracking and root-cause investigation.

Legionella Testing

Culture and qPCR-based Legionella analysis for drinking water, cooling towers and process water – with accredited on-site sampling.

Microbial Purity

Pharmacopeia-compliant microbial quality testing (TAMC/TYMC, specified organisms) for pharmaceuticals, cosmetics and supplements.

Growth Promotion Testing

Media performance validation per Ph. Eur. / USP – confirming that culture media support adequate recovery of reference organisms.

Endotoxins

Bacterial endotoxin testing by LAL and recombinant Factor C for parenteral products, medical devices and water for injection.

Sterility

Sterility testing per Ph. Eur. 2.6.1 / USP (71) for terminally sterilised and aseptically manufactured pharmaceutical products.

Analytical Spectrum

Method selection follows the analytical question – culture for quantitative assessment against regulatory criteria, PCR for speed and specificity, and MALDI-TOF for definitive identification.

Culture-Based Methods

Conventional culture-based methods are based on the cultivation of microorganisms on selective culture media. They enable the determination of total plate counts as well as specific groups, such as enterobacteriaceae. These methods provide robust and standards compliant quantitative results.

Example: Plate pour method, swab method.

Molecular Methods

Molecular methods utilise the detection of nucleic acids for the rapid identification of microorganisms. These methods enable the targeted detection of pathogens such as Salmonella spp. or Listeria spp. They offer high sensitivity and short analysis times.

Example: PCR.

Microbial Bio-Chemical Methods

Microbial bio-chemical methods enable the differentiation of microorganisms based on their metabolic activity. Commercial test systems support standardised evaluation. These methods complement culture-based methods through functional characterisation.

Example: Catalase assay, oxidase assay.

Species Identification

Species identification is carried out using modern technologies. These methods allow to precise and rapid classification at the species level. They are particularly relevant for complex samples and unknown isolates. These ensures reliable microbiological characterisation.

Example: MALDI-TOF, sequence analysis.

Matrices We Analyse

Microbiological requirements are highly matrix-specific. Sampling strategy, method selection and acceptance criteria differ by product type, process and intended use.

Regulatory Framework

DIN EN ISO/IEC 17025
Accreditation ensures reliable, reproducible test results for a wide range of product categories, such as food, drinking water, feed, pharmaceuticals products, medical devices, and environmental samples.

Pharmaceuticals: GMP §14 Abs 4 AMG, Ph. Eur., USP
These standards define microbiological test methods, limit values and validation requirements to ensure the quality od sterility of pharmaceutical products.

Food & Beverage: Regulation (EU) 2023/915, LMIV
They regulate contaminants, labelling and quality assurance through accredited analysis in the food and beverage industry.

Environmental: Regulation (EC) No 852/2004, HACCP, ISO 18593
These regulations structure hygiene management, sampling procedures and microbiological process controls in production environments.

Water: Drinking water Ordinance, DVGW W551, UBA recommendations
These set microbiological limit values and measures to ensure hygienic water quality.

Feed & Pet Food: Regulation (EC) No 767/2009, FEDIAF, Directive 2002/32/EC
These regulations define requirements for the safety, composition and microbiological quality of feed.

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