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.
Field of application
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.
The entire process, from selecting suppliers to supporting our customers, follows GMP rules. The final inspection and packaging takes place under clean room conditions.
Second Party and Third Party Audits require us to continuously develop our quality standard.
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