Microbiological analysis

Microbiological analysis according to the pharmacopoeiaMicrobiological analysis using methods described in the European Pharmacopoeia

We conduct microbiological analysis for the pharmaceutical industry using methods adapted to the European Pharmacopoeia.

The European Pharmacopoeia consists of a set of general monographs on the manufacture of medicines, general methods of analysis for substances and medicines, and general requirements for formulations (tablets, capsules, injections, etc.). The methods of analysis can also be used in the pharmaceutical sector for substances and medicines not described in the pharmacopoeia, as well as for the analysis of raw materials used in this sector, cosmetics, and dietary supplements. All medicines sold in the 36 member states of the European Pharmacopoeia must comply with these quality standards to ensure that consumers receive products from pharmacies and other legal suppliers. Therefore, companies in the pharmaceutical sector require control analyses to be conducted following the methodologies described in the documents that make up the European Pharmacopoeia.

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We carry out the following microbiological analyses according to the methods of the European Pharmacopoeia:

Semi-quantitative MPN count of bile-tolerant bacteria, enterobacteria, and Escherichia coli
Plate count of mesophilic aerobes, moulds, and yeasts
Investigation:
- Escherichia coli
- Salmonella spp
Advisory services for identifying specific microorganisms to be controlled according to the product type, potentially using methods based on ISO standards for the analysis of cosmetics and food products
Pathogen analysis: Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, Escherichia coli, Burkholderia cepacia
Conducting suitability tests of analytical techniques for specific product matrices as per the client’s requirements, in accordance with Pharmacopoeia guidelines
Assessment of the efficacy of diluent-neutralisers in counteracting the antimicrobial effects of products

Check the accreditation at: AINIA laboratories ENAC accreditations

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Pharmacopoeia

Our solutions include:

Advising on the design of control plans
Supporting the management of sample logistics, ensuring appropriate conditions for the collection, packaging, transport, and reception of these samples
Conducting analyses using the most suitable techniques, combining criteria of high reliability, cost-effectiveness, and timelines adapted to our clients’ needs, including responding to positive release systems
Adapting, optimising, and validating analytical techniques for complex, unique, and specific matrices of our clients
Issuing results through secure and accessible platforms, based on modern information and communication technologies
Providing advice for the correct interpretation of the obtained results

Matrices: aromatic herbs, extracts, cosmetics, and dietary supplements.

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Sonia Marco

Head of Microbiology Laboratory