Quality and Regulatory Documentation
> back to E-PAK Purification Cartridges
SiliCycle scavengers have been used for decades in pilot plants and production units under GMP conditions by the pharmaceutical industry as well as CMOs and CROs. They have ran their own analysis proving that silica-based scavengers can safely be used, both in reactors and cartridges to purify their compounds.
SiliCycle is committed to high quality standards and all products are manufactured in an ISO 9001:2015 compliant facility and subjected to stringent quality control.
For any inquiries, please contact: [email protected]
All products are shipped with the following information:
- Certificate of Analysis (CoA)
- Safety Data Sheet (SDS)
- Technical Information
Other statements available under request:
- BSE / TSE Declaration (non animal-derived)
- GMO-Free Certificate
- Melamine-Free Certificate, etc.
Our Regulatory Support Files (RSF) are documents that include both proprietary and non-proprietary information on performance, chemical / thermal / mechanical stability, extractable and leachable compounds, SOPs, scale-up procedures, batch history, analytical methods and more. RSF documentation can be obtained through a Non-Disclosure Agreement (NDA). Contact us.
SiliCycle can also work with you to provide customized regulatory documents, including specific analytical tests in line with your needs.
