MEDICAL GRADE PVC COMPOUND
Modenplast products are PVC based compounds, suitable for the production of medical components using extrusion or injection techniques.
Following the medical sector’s requirements, our company developed a range of PVC DEHP FREE products free from phthalate based plasticizers.
Our compounds can be sterilised by ETO, Gamma and Beta rays and for some applications also by steam.
All Modenplast compounds are formulated using only raw materials in accordance with D.M. 21/03/’73 and subsequent amendments and European Pharmacopoeia current edition.
Every processing phase, from the mixing of the powders to the extrusion of the compounds, is automatically controlled by a computerised system.
Modenplast’s internal laboratory is able to perform chemical and toxicological analysis (appearance of the eluate, oxidable substances, acidity, alkalinity and UV spectrum), to measure the hardness of the compound, to evaluate thermal stability and to carry out an extrudability test on each production batch, in order to assure complete conformity with European Pharmacopoeia (current edition) and applicable rules.
Complete analyses are carried out periodically by approved external laboratories in order to verify the chemical and biological conformity of Modenplast products according to USP Class VI and ISO 10993-1.
Furthermore, every batch of material is followed by a certificate of conformity which grants its chemical and physical a suitability for medical use.