Microbiological Analyses

The microbiological analyses are crucial for the safety, quality, and purity of pharmaceuticals. They ensure that no microbial contaminants compromise the product, the patient, or the shelf life. Our experts conduct all microbiological tests in compliance with stringent GMP guidelines, European Pharmacopoeias (EP), and other regulatory requirements.

Our Microbiological Analyses

The testing includes the following analyses:

• Determination of Total Aerobic Microbial Count (TAMC), Total Yeast and Mold Count (TYMC)
• Testing for specific pathogenic microorganisms (e.g., Staphylococcus aureus, Escherichia coli, Salmonella spp, Pseudomonas aeruginosa)
• Endotoxin Tests (LAL Test) for parenteral preparations
• Bioburden Tests for assessing microbiological contamination
• Antimicrobial Preservative Efficacy Tests (Challenge Test)
• Environmental Monitoring in cleanrooms, production areas, or storage facilities

Ensuring Quality and Safety

Microbiological analysis is crucial for ensuring the safety of the final product for patient application. Our tests identify potential contaminations, prevent microbial growth within the product, and significantly contribute to maintaining its stability, integrity, and efficacy.

Compliance with Regulatory Requirements

The regulatory requirements for microbiological analyses are as stringent as those for chemical analyses. Our laboratory processes adhere to the guidelines of European Pharmacopoeias (e.g., EP), international guidelines (e.g., ICH), and GMP standards. This enables us to support our clients in meeting all requirements for the authorization, marketing, and safety of medicinal products.

Our Scope of Services

• Preservative Efficacy Tests
• Microbial Examination of Non-Sterile Products
    Total Viable Count Test
    Detection of Pathogenic Microorganisms
    Fungal (Yeast and Mold) Testing
    Microbiological Sterility Test
    Preservative Efficacy
    pH Value and Oxygen Content in Liquid Products