Microbiological analysis

Microbiological analyses according to pharmacopoeiaMicrobiological analyses according to methods described in the European Pharmacopoeia

We perform microbiological analyses for the pharmaceutical industry with methods adapted to the European Pharmacopoeia

The European Pharmacopoeia consists of a set of general monographs on the manufacturing of medicines, general substance and medicinal product analytical methods, and general formulation requirements (tablets, capsules, injections, etc.). The pharmaceutical sector can also use these analytical methods for substances and medicinal products not described in the pharmacopoeia, and for the analysis of raw materials used in the pharmaceutical sector, cosmetics and food supplements. All medicines sold in the 36 member states of the European Pharmacopoeia must meet these quality standards to ensure that the products obtained from pharmacies and other legal suppliers are safe for consumers. For this reason, pharmaceutical companies are required to carry out control analyses in accordance with the methodologies described in the European Pharmacopoeia documents.

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We perform the following microbiological analyses according to the European Pharmacopoeia methods:

Semi-quantitative MPN count of bilitolerants, Enterobacteriaceae and Escherichia coli
Plate count of mesophilic aerobes and moulds and yeasts
Research:
- Escherichia coli
- Salmonella spp
Consultation when identifying specific microorganisms to be controlled depending on the type of product, using ISO standard-based methods for the analysis of cosmetics and foodstuffs
Pathogen testing: Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, Escherichia coli, Burkholderia cepacia
Performance of suitability tests for analytical techniques on customer-specific product matrices, according to Pharmacopoeia guidelines
Assessing efficacy of diluents-neutralisers on the antimicrobial properties of products

Consult accreditation in: ENAC accreditations AINIA laboratories

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Farmacopea

Our solutions include:

Consultation regarding the design of control plans
Providing support in managing the logistics of samples in order to adapt the conditions of collection, conditioning, transport and reception of samples
Analyses are carried out using the most suitable techniques, combining the highest reliability criteria with costs and deadlines adapted to the needs of our clients, even when responding to positive release systems
Adaptation, fine-tuning and validation of analysis techniques on complex, exclusive and customer-specific matrices. Results are delivered through secure and accessible platforms, based on the most advanced information and communication technologies
Consultation to ensure the correct interpretation of the obtained results

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

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Sonia Marco

Head of Microbiology Laboratory