Detergents

PureDTU detergent

The cleaning process or bioneting includes the possible use of detergents. Annex I of the GMP, in chapter 4.36, states: "They (cleanrooms) should be cleaned and disinfected thoroughly in accordance with a written programme. For disinfection to be effective, prior cleaning to remove surface contamination should be performed." (The cleanrooms need to be cleaned and disinfected perfectly, in accordance with a written document. For disinfection to be effective, cleaning must be carried out beforehand to remove contamination from surfaces).
This detergent is low-foaming, pH-neutral, ready-to-use, sterile or non-sterile.

Sterile, bi-distilled, non-pyrogenic water

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• OTEC range
- 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 ».
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.

• VERSOL range
- 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 (analysis bulletin)