We have conducted extensive extractables testing as well as compendial and biocompatibility testing as per ISO, USP, EP and JP.Our company is works closely with regulatory authorities and sponsors on a worldwide basis to support drug submissions. Working closely with FDA’s Emerging Technology Group and under FDA recommended testing, the company has demonstrated a like-for-like equivalence to glass containers of the SiO2 containers.
SiO2 Materials Science’s state-of-the-art, 165,000 ft² facility in Auburn, AL USA includes a manufacturing plant with three clean rooms comprising a total of 40,000 ft². The company is building a second manufacturing plant in Switzerland. The manufacturing plant is registered to ISO: 13485 and 15378 and in compliance with cGMP, QSR and applicable CFR’s.
- Traceable with unique IDs
- GMP certified manufacturing
- Dry chemistry inherently clean
- Sterilizable up to 136°C
Passed compliance testing for ophthalmic products (USP 789)
- We have registered Drug Master Files from regulatory bodies