Via Molinella, 17 - 35017 Piombino Dese - Padova - Italy
Ph: +39 049 9318111
Fax: +39 049 9366151
Via Carrara, 8 - Borgo Tor Tre Ponti - 04013 - Latina - Italy
Tel: +39 0773 699111
Fax: +39 0773 699699
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As a general rule, containers made of borosilicate glass are able to meet the chemical requirements of the most well-known pharmacopeias (EP, USP, JP). The compliance to the surface test (either EP or USP) needs be explicitly required in the specs, since the process needs to be specifically set to allow a stable, low level of alkali release.
The compliance to light transmission (to be applied only to colored glass) should be evaluated very carefully: the requirements change between EP and USP (on one side) and JP (on the other side), and different types of glass behave differently from one another in terms of spectrum vs thickness. The conformity is therefore driven by the glass tubing manufacturer.
At the present moment, the plants of Piombino Dese, Latina and Monterrey have fully implemented and certified an Environmental Management System. Ompi of China is the next Ompi plant that will be certified ISO14001:2004.
Yes, all Ompi plants, together with Spami and the holding Stevanato Group ,have fully implemented and certified a harmonized Quality Management System in compliance with ISO9001:2008.
Yes, all Ompi plants and the holding Stevanato Group are full compliance with GMP requirements of ISO15378:2011.