Ph. Eur. 2.6.12
Defines standardized methods for the quantitative determination of aerobic microorganisms (TAMC, TYMC) in non-sterile pharmaceutical products.
Microbial purity testing plays an essential role in pharmaceutical quality control and helps verify the microbiological quality of raw materials, in-process materials and finished products. Regulatory expectations apply across a wide range of pharmaceutical products, medical devices, water systems and controlled manufacturing environments.
Reliable microbiological testing supports product quality, process control and regulatory compliance throughout development, manufacturing and release.
We support pharmaceutical manufacturers and medical device companies with microbial purity testing for product development, process validation, routine quality control and release testing. Accreditation to DIN EN ISO/IEC 17025 provides the foundation for scientifically sound and GMP-compliant results.
Ph. Eur. 2.6.13
Defines methods for the detection and identification of specified microorganisms used to assess microbiological risks.
Ph. Eur. 5.1.8/2.6.31
Defines testing strategies for the determination of total microbial count and specified microorganisms in herbal medicinal products and plant-derived materials.
Ph. Eur. 0169/0008
Defines microbiological quality requirements and testing procedures for purified water and water for injections.
EU GMP Annex 1
Defines risk-based strategies for monitoring and controlling microbial contamination in cleanrooms and controlled manufacturing environments.
Raw Materials & Excipients
Verification of microbiological quality before use in pharmaceutical manufacturing processes.
Typical samples: Active pharmaceutical ingredients, excipients, powders and starting materials.
Typical applications: Incoming material qualification, supplier qualification, risk assessment and contamination prevention.
Solid Dosage Forms
Microbiological quality assessment of non-sterile solid pharmaceutical products to verify compliance with pharmacopoeial microbial limits and product-specific specifications.
Typical samples: Tablets, capsules, powders, granules and oral solid dosage forms.
Typical applications: Routine quality control, stability studies, release testing and GMP compliance.
Semi-Solid Pharmaceutical Products
Assessment of microbiological quality in semi-solid dosage forms where product composition may influence microbial growth and analytical recovery.
Typical samples: Creams, ointments, gels, pastes and topical formulations.
Typical applications: Microbial limit testing, product development, release testing and quality assurance.
Liquid Pharmaceutical Products
Microbial purity testing of aqueous and non-aqueous liquid formulations throughout development, production and release.
Typical samples: Oral liquids, syrups, suspensions, solutions and liquid preparations.
Typical applications: Routine testing, release control, stability studies and qualitiy verification.
Finished Pharmaceutical Products
Final microbiological quality verification before product release and market distribution.
Typical samples: Packaged pharmaceutical products, finished dosage forms and commercial product batches.
Typical applications: Release testing, batch approval, GMP compliance and quality assurance.
Endotoxins
Endotoxin and microbial purity testing are complementary quality control measures for pharmaceutical products. Combined evaluation supports the assessment of microbiological quality, particularly for parenteral products and pharmaceutical water systems.
Microbial Identification
Atypical or unexpected microbiological findings in pharmaceutical products, water systems or controlled manufacturing environments often require species-level identification. Identification data support contamination investigations, risk assessment and corrective actions.
