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Significance of Aluminium Release from Type I Borosilicate Glass Containers

Alberto Biavati¹, Paolo Amadei¹, Arianna Ferrarini¹, Michele Poncini¹, Luca Zalaffi¹, Maura Mantovani²

¹ Bormioli Rocco e Figlio SpA, Fidenza, Italy
² Azienda Unità Sanitaria Locale, Parma, Italy

Corresponding author: Alberto Biavati, Bormioli Rocco e Figlio SpA, Via Martiri della Libertà 1, 43036 Fidenza (PR), Italy

Aluminium is the third most abundant element in the lithosphere after silicon and oxygen and may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Alumina (Al2O3), as a glass network former, is very important to improve the chemical inertia of glass towards aqueous solutions attack. The release of aluminium from borosilicate glass comes from the dissolution of a very thin superficial layer of the glass during the hydrolytic attack. The aluminium release from type I glass containers of different composition was compared after autoclaving of 1 h at 121 °C according to the European Pharmacopoeia (EP) 6. This autoclaving cycle corresponds to approximately 5 years of contact between the glass surface and the solution at ambient temperature. USP 32 fixes a limit of 25 μg/l for large volume solutions used for total parenteral nutrition; EP 6 fixes a limit of 15 μg/l for solutions for peritoneal dialysis and of 10 μg/l for sterilised water for use in the manufacture of dialysis solutions, where very large volumes are involved. 200 μg/l (ppb) is the limit for aluminium in human albumin. Sodium lactate solution for parenteral dosage forms has a limit of 0.1 μg/ml (ppm). The aluminium release from other packaging materials (polyolefins etc.) was not determined but apparent discrepancies were evidenced on the basis of the very high permissible limits of release of EP 6 and USP 32 (1 μg/ml) for these materials.
To evaluate the significance of aluminium intake from type I glass containers, some large volume parenteral therapies were evaluated. Due to the small volumes coming from type I glass containers, aluminium loading from glass was assessed to be negligible.

Key words Aluminium release • Glass chemical durability • Parenteral nutrition • Polyethylene for containers • Polyolefins for containers • Polypropylene for containers • Type I glass containers