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Microbiological Analysis

Reliable detection, identification and evaluation of microorganisms in food, pharmaceuticals, water and packaging materials. Standard-compliant testing provides the basis for product safety, regulatory compliance and informed quality decisions.

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Multiple Petri dishes with microbiological cultures are placed under laboratory lighting on a work surface.

From Raw Material to Release –
Microbiological Safety Across the Product Lifecycle

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

Microorganisms can impact product safety, quality, shelf-life, and regulatory compliance in different ways. Pathogens, spoilage organisms, hygiene indicators, and pharmaceutical quality parameters each require dedicated analytical approaches, specific evaluation criteria, and regulatory expertise.

Our microbiological testing portfolio brings these disciplines together, combining specialised methods with matrix-specific knowledge to generate reliable results for quality assurance, risk assessment, and compliance verification.

As an ISO/IEC 17025-accredited laboratory network with GMP authorisation under §14(4) AMG, we provide scientifically sound data for informed decisions across food, water, feed, pharmaceutical, and packaging applications.

Parameter Portfolio

Microbiological analyses provide reliable data for assessing contamination, hygiene conditions, product quality, and regulatory compliance. The parameter portfolio is structured around key microbiological risk areas and supports informed decisions throughout the product lifecycle.

Pathogens

Detection of microorganisms relevant to consumer safety, product safety, and regulatory compliance. Testing focuses on pathogenic bacteria and other microorganisms that pose a risk to public health, including foodborne and waterborne pathogens.

Methods: Culture-based techniques and molecular methods, including PCR.

Typical organisms: Salmonella spp., Listeria monocytogenes, Campylobacter spp., STEC, Legionella pneumophila, Staphylococcus aureus.

 

Spoilage Organisms

Assessment of microorganisms affecting product stability, shelf-life, sensory quality, and commercial usability throughout the production chain, including spore-forming microorganisms relevant to product safety and stability.

Methods: Traditional cultivation techniques combined with molecular detection methods.

Typical organisms: Bacillus spp., lactic acid bacteria, yeasts, moulds, and spoilage-associated flora.

 

Hygiene Indicators

Microbiological indicators used to assess process hygiene, production environments, cleaning effectiveness, and raw material quality.

Methods: Predominantly culture-based methods and quantitative bacterial count determination.

Typical organisms: Escherichia coli, Enterococcus spp., Enterobacteriaceae, coliform bacteria.

Microbial Identification

Identification and characterization of microorganisms to determine contamination sources, investigate deviations, and support root-cause analysis.

Methods: MALDI-TOF MS, molecular sequencing, biochemical characterization.

Typical applications: Species identification, contamination tracing, isolate characterization.

 

Pharmaceutical Microbiology

Assessment of microbiological quality attributes relevant to pharmaceuticals, cosmetics, medical devices, pharmaceutical water systems, and healthcare applications.

Methods: Pharmacopoeia-compliant testing including sterility testing, endotoxin determination, microbial purity testing, and growth promotion testing.

Typical applications: TAMC, TYMC, sterility testing, endotoxin testing, growth promotion testing.

 

Analytical Scope

Microbiological testing encompasses a broad range of specialized disciplines addressing product safety, process hygiene,
quality assurance, and regulatory compliance. Dedicated analytical methods and matrix-specific expertise ensure reliable results
for a wide variety of industries and applications.

Pathogens

Detection and confirmation of foodborne pathogens in accordance with Regulation (EC) No. 2073/2005, supporting product safety and regulatory compliance.

Spoilage Organisms

Quantification and identification of yeasts, moulds, lactic acid bacteria, and spoilage-associated microorganisms for shelf-life and product stability assessment.

Hygiene Indicators

Microbiological assessment of production environments, process hygiene, and raw material quality using established indicator organisms and quantitative microbiological criteria.

Spores & Spore Formers

Detection and enumeration of heat-resistant endospores and toxin-producing spore-forming microorganisms in thermally processed and shelf-stable products.

Microbial Identification

Species-level identification using MALDI-TOF MS and molecular methods to support contamination source tracking and root-cause investigations.

Legionella

Culture-based and molecular analysis of Legionella in drinking water, cooling water, and process water systems, including accredited on-site sampling.

Microbial Purity

Pharmacopoeia-compliant microbial quality testing for pharmaceuticals, cosmetics, and food supplements.

Growth Promotion Testing

Verification of culture media performance according to Ph. Eur. and USP requirements to ensure adequate recovery of reference microorganisms.

Endotoxins

Determination of bacterial endotoxins using LAL and recombinant Factor C methods for parenteral products, medical devices, and Water for Injection (WFI).

Sterility

Sterility testing in accordance with Ph. Eur. 2.6.1 and USP  (71) for terminally sterilised and aseptically manufactured pharmaceutical products.

Analytical Spectrum

Different analytical questions require different methodological approaches. Culture-based techniques provide quantitative results for regulatory assessment, molecular methods deliver rapid and targeted detection, and advanced identification technologies enable definitive microbial characterization.

Culture-Based Methods

Cultivation on selective media for detection, enumeration, and assessment of microbial populations in accordance with recognized standards.

Examples:  Plate count methods, membrane filtration, swab testing .

Molecular Methods

Rapid and highly specific detection of target microorganisms through nucleic acid-based technologies.

Example: PCR.

Microbial Bio-Chemical Methods

Differentiation of microorganisms based on metabolic and enzymatic activity to support identification and confirmation.

Examples:  Catalase test, oxidase test.

Species Identification

High-resolution identification technologies for precise classification and contamination source investigations.

Examples: MALDI-TOF,  DNA sequencing.

Matrices We Analyse

Microbiological requirements are highly matrix specific. Sampling strategies, analytical methods, acceptance criteria, and regulatory requirements vary depending on product type, manufacturing process, and intended use.

Regulatory Framework

Microbiological testing is performed in accordance with internationally recognized standards, regulatory requirements, and industry-specific guidelines. These frameworks define analytical quality, acceptance criteria, validation requirements, and compliance obligations across different sectors.

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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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