Q: Do the containers produced by Stevanato Group Glass Division Companies meet different pharmacopeia requirements?
A: As a general rule, containers made of borosilicate glass are able to meet the chemical requirements of the most known parmacopeias (EP, USP, JP). The compliance to the surface test (either EP or USP) need be explicitely required in the specs, since the process need to be specifically set to allow a stabile low level of alkali release
The compliance to light transmission (to be applied only to coloured glass) should be evaluated very carefully: the requirements change between EP and USP (on one side) and JP (on the other side), and different glass behave differently from each other in terms of spectrum vs thickness. The conformity is therefore driven by the glass tubing manufacturer
Q: Do Stevanato Group Glass Division Companies meet ISO14001:2004 requirements?
A: All Companies are in full compliance with all legal requirements; at the present moment, Piombino Dese site (therefore Nuova Ompi - including EZFill - and Spami) and Latina site (therefore Alfamatic) have fully implemented and certified a harmonized Environmental Management System.
Q: Do Stevanato Group Glass Division Companies meet ISO9001:2000 requirements?
A: All Companies of SG-Glass Division and Spami have fully implemented and certified a harmonized Quality Management System in compliance with ISO9001:2000 (harmonization in progress for MG)
Q: Do Stevanato Group Glass Division Companies meet ISO15378:2006 requirements?
A: An update of the structure of the Quality Management System is in implementation phase in order to formalize the details about how the different GMP requirements are met; this is also challenged in all system audit we receive.
At the present moment the certification is scheduled for Q4 08 - Q1 09.
Q: Do Stevanato Group Glass Division Companies meet cGMP requirements?
A: The QMS of the Pharma Division (EZ-fillTM) is in full compliance with GMP and EU-GMP, due to the specific type of containers produced. The Glass Division has made reference to GMP since the beginning of 90's; now the ISO15378:2006 is the guideline used to formalize the way the requirements are interpretated and satisfied.