Please note, this OEL/ADE monograph also applies to silicon dioxide, amorphous (CAS RN 7631-86-9). There is no therapeutic indication for aquafil. Aquafil is a synthetic amorphous silica (silicon dioxide ) and is produced by a vapor phase hydrolysis process using chlorosilanes or substituted silanes such as, silicon tetrachloride in a flame of hydrogen and oxygen. This material is formed and collected in a dry state. This product contains no detectable crystalline silica.
Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.
OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), as well as PIC/S and ANVISA requirements, and to obtain the following information:
To order an OEL/ADE monograph for Aquafil, just click the ADD TO CART button.
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Affygility Solutions’ OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.