iLibeads® Type P PHARMA RTS Chemical/Technical Parameter Article: Glass Beads Borosilicate Type I Glass RTS (Ready to Sterilize) 2.50 mm +/- 0.10 mm polished Article No. 55-02500-88RTS Type of glass and applied Glass Beads are in accordance with the current versions of regulations: Pharmacopoeia Ph. Eur., USP and JP Cleaning Process and Water Quality applied regulations: Water for Injections (WFI) in accordance with the European Pharmacopoeia (Ph. Eur. Monograph 0169) Washer Washer meets GMP, GAMP and FDA 21 CFR Part 11 requirements. Cleanroom Cleanroom conditions ISO 7 in accordance with DIN EN ISO 14644; Grade C (GMP). Chemical Composition SiO2 81 % The heavy metal content (Pb, Cd, Hg, Cr-VI) is below 100 ppm Chemical Resistance Hydrolytic Resistance HGA 1 (DIN ISO 720) according DIN methods: Acid Class S1 (DIN 12116) Surface roughness: Technical Specification Glass Beads for Medicinal Applications 55-02500-88RTS Page 1 of 2

iLibeads® Type P PHARMA RTS Sphericity: 0.1 mm Inspection Strategy: © 100 % Quality Control by a permanent validated optical inspection systems in clean room class 7 (EN ISO 14644) / Grade C (GMP) © Final inspection by attributes in accordance to DIN ISO 2859-1 Technical Specification Glass Beads for Medicinal Applications 55-02500-88RTS Page 2 of 2