SiLibeads® – High-quality glass beads for insulin

Mixing insulin:
SiLibeads^® Type P pharmaceutical glass beads are made from Type I borosilicate glass of the highest purity. These beads are produced with the utmost care in a certified process that takes place under clean room conditions in accordance with GMP guidelines and comply with ISO 9001 and ISO 15378 standards.

For over 20 years, we have specialised in the manufacture of glass beads used as primary packaging in 3 ml cartridges for mixing insulin in suspension. We supply the global market with our 2.5 mm glass beads. Our production and processes are specially tailored to this product. Optical sorting and inspection systems ensure the highest quality standards for our customers. Washing with high-purity water (WFI quality) allows our beads to be used directly by customers worldwide for ‘ready to sterilise’ (RTS) applications.

The use of a glass bead with a diameter of 2.5 mm in an insulin cartridge has several important functions:

• Mixing aid: The glass bead helps to mix the insulin efficiently, especially in the case of insulin suspensions that need to be mixed before administration. By shaking the cartridge, the glass bead ensures that the insulin is distributed evenly, which is crucial for correct dosing.
• Quality control: The bead can also serve as a quality control tool. Its movement within the cartridge can help the user determine whether the insulin has the correct consistency and is free of contaminants.
• Dosage control: In some designs, the glass bead can also serve to facilitate dosing by enabling the insulin to be delivered evenly and accurately.
• Compatibility: Borosilicate glass is chosen because it is chemically inert and does not react with insulin. This is important to ensure the stability and effectiveness of the insulin. The glass is also made of the same material as the cartridge itself. The beads are therefore a primary packaging material.
• The specific size of 2.5 mm is the result of design considerations that take into account the size of the cartridge, the viscosity of the insulin and the requirements for efficient mixing and administration.

• Certifications: We are certified according to DIN EN ISO 15378, DIN EN ISO 9001 and HACCP, which guarantees compliance with the highest quality standards.
• GMP-compliant manufacturing: All processes are structured in accordance with strict GMP guidelines to ensure the safety and effectiveness of our products.
• Clean room conditions: The final inspection and packaging of our beads takes place under controlled conditions to prevent contamination.
• Optical sorting and inspection systems: These systems ensure the highest quality standards and support the traceability of our products.

SiLibeads® PHARMA