PD ISO TS 210:2014 pdf free

PD ISO TS 210:2014 pdf free.Essential oils一General rules for packaging, conditioning and storage
The anodic layer may be coloured by pigments or colourings, provided that they are authorized by the regulations in force in the countries concerning the materials and products in contact with food. (See Clause 3).
A compulsory final filling operation is applied with the exception of the aluminium or aluminium alloy materials and products anodized in a phosphoric medium or covered by coating, in conformity with the Article 4 of Reference [3]. This operation shall be carried out with distilled or demineralized water containing either 8 g/l of nickel acetate and 1 g/l of cobalt acetate or one of these two salts at the maximum concentrations indicated.
All the technical conditions and particularly the temperature and the standing time shall be chosen in such a way that, at the end of the operation, the oxide layer formed during the anodization process, loses its absorption power due to its natural porosity, and acquires optimum inertness.
No material or substance placed in contact with an essential oil for pharmaceutical use shall perceptibly adulterate its composition or modify its activity.
All packaging shall have a Licensing Approval delivered by the relevant authorities.
NOTE This authorization forms a part of the Licensing Pharmaceutical dossier.
Depending on the country, the regulations applicable to containers and packaging differ, but generally refer to general principles of Pharmacopoeia (European,1) American,[21] or Japanese,[22] etc.), which specify,among other things, that a study relating to the possible interaction between the container and the product should be undertaken in each case where a hazard may appear, and
一national standards or regulations if there is no specific or relevant Pharmacopoeia monograph.
If containers intended for containing essentials oils for food use (2.1) or pharmaceutical use (2.2) are coloured, the pigments or colourings used shall comply with the regulations in force, similar to those of the additives of plastics.They shall have a high level of purity and the maximum content in mineral elements is shown in Table 4.PD ISO TS 210 pdf download.