SiLibeads® in direct contact with pharmaceutical and medical products

The use of SiLibeads® in the pharmaceutical sector requires compliance with all legal requirements of the target markets, verifiably effective quality management systems, highest precision, and purity of the product and the entire production process. State-of-the-art management methods, qualified and validated production and testing processes ensure that the high requirements of pharmaceutical companies are met. SiLibeads for the pharmaceutical industry can be cleaned according to customer requirements in special washing processes up to the classification RTS ready to sterilize.

Fields of application

Mixing insulin
SiLibeads® Type P Pharma Glass Beads are manufactured from borosilicate glass type I of the highest purity. These beads are produced with the utmost care in a certified process under clean room conditions in accordance with GMP guidelines and comply with ISO 9001 and ISO 15378 standards.

For more than 20 years, we have specialised in the production of glass beads used as primary packaging in 3 ml cartridges to mix insulin in suspension. We supply the global market with our product, 2.5 mm glass beads. Our production and processes are specially adapted to this specialised product. Optical sorting and control systems ensure the highest quality standards for our customers. Washing with high-purity water (WFI quality) enables our beads to be used directly by customers worldwide for “Ready to Sterilise” (RTS) applications.


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Bead Beating
A common mechanical method for cell disruption uses glass, ceramic or steel beads of sizes 0.1 – 6.0 mm mixed with a sample suspended in aqueous media. The method is called “bead-beating”. Beads collide by agitation, stirring or shaking with the sample material, cracking open the cell to release intercellular components. The components range from different kinds of cellular materials, spores, animal and plant tissues. The advantages are the disruption of small sample sizes and a high number of samples at a time. The bead-beating process depends both on the machine, its parameters and the right selection of the bead material and size. Various bead-beating machines are available on the market and have rates of agitation from 2000 up to 20000 oscillations per minute. For such high oscillation rates high quality beads are necessary to prevent a contamination of the disrupted products by increased wear or broken beads.

Cell disruption by bead beating

Additional areas of application for our glass beads include

  • Use as valve spheres in medical devices
  • Use as a carrier material for active pharmaceutical ingredients (APIs)
  • Use in diagnostics
  • Use in the treatment of osteoarthritis.

The entire process, from selecting suppliers to supporting our customers, follows GMP rules. The final inspection and packaging takes place under clean room conditions.

Audits confirm our high quality standards.

We are certified according to the following quality standards:

  • DIN EN ISO 15378 GMP Primary packaging for pharmaceuticals
  • DIN EN ISO 9001 Quality Management System
  • HACCP hygiene standard

Brief information about SiLibeads® Pharma Glass

SiLibeads Typ P PHARMA für medizinische Anwendungen

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