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® Glass Beads are also used for cell disruption in special ampoules, e.g. to isolate certain components of the cell (e.g. DNA).
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