OEL Fastrac Catalog

Thimerosal, also known as thiomersal, is an organomercury antiseptic and antifungal agent used as a preservative in vaccines, immunoglobulins, nasal sprays, and contact lens solutions. Thimerosal was used as a component of topical antiseptic solution and antiseptic ointment for treating cuts and as a component of nasal sprays, eye solutions, vaginal spermicides, and diaper rash treatments, but reevaluation of the drug in the 1980s demonstrated ineffectiveness and toxicity in topical pharmaceutical products, and topical thimerosal was withdrawn from the market. Thimerosal is used as a preservative for influenza (flu) vaccines in multidose vials for adults. Thimerosal is also used during the manufacturing process for two childhood vaccines to prevent the growth of microbes, and it is removed later in the process. It had been removed from uses in vaccines and products that target immunoglobulins. In the United States of America (USA) and European Union countries, thiomersal is no longer used in childhood vaccines due to public fears, although the Food and Drug Administration (FDA) review of 1999 found no evidence of harm from the use of thimerosal as a vaccine preservative other than local hypersensitivity reactions.

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.

Why do you need this OEL Fastrac monograph?

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:

• The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
• A listing of all cited references utilized in the derivation of the OEL and ADE
• An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

• Fully documented. Over 20 pages in length, with calculations and cited references.
• Save time! Unsurpassed delivery with instant download.
• Save money. Similar documents cost 5-12 times as much.
• Stay current. Automatic notification of revisions.

How to order

To order an OEL/ADE monograph for Thimerosal, just click the ADD TO CART button.

HBEL

If you're wondering about HBEL, we have something for you.