All the process and developmente production are according to international quality standards EN ISO 9001: 2015, good manufacturing practices ISO 22716: 2008 and medical devices EN ISO 13485: 2016 of which Aneva Italia has the certifications.

Quality assurance is carried out starting from the evaluation of raw material, to the standards dictated by the Pharmacopoeia up to the multi-stage checks during the manufacturing process.

The microbiological analyzes are performed to search for:

• batteri mesofili totali
• lieviti e muffe
• Staphilococcus aureus
• Candida albicans
• Escherichia coli
• Pseudomonas aeruginosa

Tests are carried out:

• thermal stability
• accelerated stability
• pH measurement
• electrode Potential
• determination of moisture content
• density measurement

Aneva Italia is certified according to international quality standards EN ISO 9001: 2015 certificate no. IQ-0913-03 , GMP ISO 22716: 2008 cert. n. IGMP-0918-01 , production of medical devices 13485: 2016 cert. n. IMD-0913-01
Aneva Italia ensures the maintenance of its quality management system, through periodic and constant checks on the correct application of the provisions of management procedures, process flows and quality policy in all company areas, with internal audits and specific reviews.