PHARMACOPOEIA is a term that refers to a legislative text that describes quality assurance requirements for substances used in the pharmaceutical industry. The European version of this text is a process of supranational harmonization of these standards which details specific and strict regulations which all manufacturers of products intended for pharmaceutical and medical applications must adhere to.
Unfortunately, in recent years, there have been cases in which end users have been severely damaged by contaminated products. Thus, as a result of these unfortunate incidents, controls have been intensified to ensure conformity with the Pharmacopoeia regulations.
Suppliers of parts and materials to producers of medical devices or pharmaceutical containers are thus subject to the aforementioned controls as well. Plastics are increasingly used in these sectors thanks to their good performance, but at the same time they have to meet specific requirements such as biocompatibility, resistance to sterilization, migration and necessarily have to be free of impurities or toxic substances which, could damage the end-product.
VIBA Laboratories have created two new formulations, VIBATAN® PP WHITE 14132 and VIBATAN® PE WHITE 14133, specifically developed with additives aimed to meet the requests for products which have to comply with regulations dictated by Pharmacopoeia, and in particular with point 6.0 for secondary packaging,(chapter 3.1), which regulates contact with medicines.
These products are based on raw materials which in many countries not only meet the existing regulations on food packaging, but which have been specifically selected because of their high chemical purity and conformity to pharmaceutical standards.
The most common final applications are in particular, bottles and containers for medicines. VIBATAN® LDPE ANTI UV 03704 has been specifically formulated for UV stabilization of polyethylene and polypropylene. It can be easily added during the extrusion or injection moulding of the end products aimed to be approved by Pharmacopoeia.
This Masterbatch does not affect the colour of the final product and can also be used in critical process conditions (high temperatures).
VIBA’s Technical Department is at disposal for any further information you may require.