Directives and standards Aguettant OTEC water is an Active Pharmaceutical Ingredient (API) (Used as a pharmaceutical primary material excluding injectable, ophtalmic or inhaled products). Complies with directives NF EN ISO 3696 type 3 and European pharmacopeia's monograph «purified water in container » . New Monograph « sterile purified water » American pharmacopeia (excluding non-sterile 10 litres container)
Uses For rinsing and irrigation of materials and tools, white rooms cleaning, machine washing , and acting as an active substance for the manufacture of medicaments.. OTEC range cannot cannot be used neither in the hospital sector, nor for rinsing and irrigation of wounds.
Directives and standards VERSOL sterile non pyrogenic water complies with P.P.I and the current European pharmacopeia's monographs. In compliance with DM IIa (sterile), ISO 9001 and NF EN ISO 13485 certifications.
Uses These flasks are used for rising and irrigation of wounds ; they are sterile and of single use. Must not be used for injections.
Documents provided upon request (bulletin d'analyses)
• Pyrogenic • Purified water, reverse osmosis, demineralised • Resistivity > 0.5 MΩ. cm • Compliant with current European Pharmacopoeia - Monograph Purified water packaged in container • Compliant with current US Pharmacopeia - Purified water monograph • Complies with NF ISO3696 standard type 3 • Bacteriological quality < 10UFC/100 ml • Analysis Bulletin on request • Applications :rinsing the medico-surgical during disinfection protocols that do not require sterile water, final rinsing of laboratory instruments, cleaning in clean room, solutions preparation for PLC, buffer solutions realisation
Packaging: the Miniversol 0.9 % sterile sodium chloride for rinsing and irrigation is sold in volumes from 45 ml to 1 L. The batch number and expiry date are indicated on the flask labels. Guaranteed for more than one year.
Directions and recommended uses: physiological solution for rinsing, irrigation of the skin, wounds and surgical cavities and general laboratory use. Use as primary material for the manufacture of non-injectable medicines, culture media etc.
Documents provided on request : conformity assessment to the applied European Pharmacopeia's monograph ''purified water packaged in can'' and to the ISO 3696 type 3 norm.