- Microbiology
Pharmacopoeia
Microbiological analysis
Microbiological analysis according to the European Pharmacopoeia
Quality control for the pharmaceutical industry with standardised analytical methods
Medicinal products marketed in the 36 member states of the European Pharmacopoeia must comply with rigorous quality standards. To ensure this, it is essential for companies in the pharmaceutical sector to carry out microbiological quality control analyses in accordance with the methodologies described in this regulatory compendium. The European Pharmacopoeia includes general monographs on the manufacture of medicinal products, analytical methods applicable to active substances and finished products, as well as raw materials used within the sector. These methods are not only applied to medicinal products described in the pharmacopoeia, but also to non-pharmacopoeial medicines, cosmetics and food supplements. Adapting analytical processes to these requirements ensures the quality and safety of products before they reach the final consumer.At AINIA, we add value
- Semi-quantitative enumeration by MPN of bile-tolerant microorganisms, Enterobacteriaceae and Escherichia coli
- Plate count of mesophilic aerobes, moulds and yeasts
- Detection: Escherichia coli and Salmonella spp.
- Advisory on the identification of specific microorganisms to be controlled depending on the product type, using ISO-based methods for the analysis of cosmetics and food
- Análisis de patógenos: Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, Escherichia coli, Burkholderia cepacia
- Performance of suitability testing of analytical techniques for client-specific product matrices, in accordance with Pharmacopoeia guidelines
Pharmacopoeia
- Advice on designing control plans
- Support in sample logistics management to ensure appropriate collection, handling, transport and reception conditions
- Carrying out analyses using the most appropriate techniques, combining high reliability criteria with costs and turnaround times adapted to our clients’ needs, including support for positive release systems
- Adaptation, optimisation and validation of analytical techniques for complex, exclusive and client-specific matrices. Results are issued through secure and accessible platforms based on modern information and communication technologies
- Advice for correct interpretation of the results obtained
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Sonia Marco
Head of Microbiology Laboratory
