Advanced Minerals’ High Purity filter aids that are supplied as pharmaceutical components come in a variety of packaging configurations, including Flexible Intermediate Bulk Containers (FIBC).

Non-bulk options include 5-15 kg lined poly drums as well as 10-22.7 kg Tyvek* bags. All non-bulk options address USP-NF and pharmaceutical CGMP requirements. This includes compliance with:

	21 CFR 211.94 (a)
	"Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug beyond the official or established requirements."
	21 CFR 211.94 (b)
	"Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product."
	21 CFR 177.1520
	Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces
	USP-NF 25 NF 120
	Cytotoxicity testing by the Elution Test
For bagged options, Tyvek represents a major advancement in filter aid packaging. Unlike the paper bags in which conventional diatomite is packaged, Tyvek is ideal for use in CGMP facilities. *Tyvek is a register trademark of Dupont Corporation

Products- High Purity Filtration, Sorbents, Gas-Liquid Chromatography, Sample Request
Support- Application Notes, MSDS - NAFTA, Data Requests, Glossary

Home . Contact Us . Site Map . Terms of Use . Privacy Policy