Farmacopea Microbiológico

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.

At AINIA, we bring you value

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