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Type P PHARMA

Product catalog summary

Technical Specification Overview:
SiLibeads® Type P PHARMA RTS glass beads are designed for medicinal applications, specifically ready to sterilize (RTS). The document outlines the specifications, chemical composition, inspection strategy, and storage recommendations for these glass beads.

Specifications:

Article: Glass Beads Borosilicate Type I Glass RTS
Size: 2.50 mm +/- 0.10 mm polished
Compliance: Meets Pharmacopoeia Ph. Eur., USP, and JP standards
Cleaning Process: Uses Water for Injections (WFI) as per European Pharmacopoeia
Cleanroom Conditions: ISO 7, Grade C (GMP)

Chemical Composition:

SiO2: 81%
B2O3: 13%
Na2O + K2O: 4%
Al2O3: 2%
Heavy metals (Pb, Cd, Hg, Cr-VI) below 100 ppm

Chemical Resistance:

Hydrolytic Resistance: HGA 1 (DIN ISO 720)
Acid Class: S1 (DIN 12116)
Alkaline Class: A2 (DIN ISO 695)

Physical Properties:

Density: 2.23 kg/dm³
Diameter Tolerance: +/- 0.10 mm
Surface Roughness: Sa < 0.111 µm
Sphericity: 0.1 mm
Ovality: max 0.1 mm
Quantity per kg: ≈ 54,800 pcs.

Inspection Strategy:

100% quality control using validated optical inspection systems in cleanroom class 7
Final inspection by attributes according to DIN ISO 2859-1
Criteria include diameter, wrong beads, broken beads, hair-like fibers, cosmetic defects, and foreign material

Packaging and Storage:

Packaging defined with the customer, recommended shelf life of 1 year in sterilizable bags
Storage conditions: Dry, room temperature, protected from heat and sunlight

Issued and Released by:

Reinhold Schneider, Quality Manager
Michael Dressler, Head of Quality/Product Manager for Pharma and Food Applications
Effective Date: 12.12.2019

Catalog excerpts

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

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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

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