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The US FDA mainly regulates prefilled syringes under pharma product regulations, and in the EU they are considered to be pharmaceutical components. As such, the glass supplier becomes the starting point in the pharma customer production chain. Glass container suppliers thus share responsibility for the drug integrity and efficacy with the pharma company. As Dr Andrea Sardella, R&D Manager at S.P.A.M.I. explains, this has put great pressure on glass converters for providing a well controlled production process with the same quality level as in the remaining part of the pharmaceutical chain.