OEL Fastrac Catalog

Peanut allergy is an adverse reaction of an immunological nature induced by peanut proteins. To date, 17 peanut allergens have been identified. Many of these proteins have protective functions or are seed storage proteins. Protein content is the basis for experiments determining allergenic responses (1). The protein content in peanut flour differs depending upon whether the flour is defatted or not. Protein content of defatted peanut flour has been reported to be 25%. For the basis of determining the OEL and ADE, this document focuses on the dried peanut proteins contained in the peanut flour. This analysis therefore, applies to what is commonly referred to as peanut flour.

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 and the acceptable surface limit (ASL).

Please note: Due to the complexity and amount of studies regarding this compound—a Natural Health Product—increased cost is charged.

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 Dried Peanut Proteins, just click the ADD TO CART button.

HBEL

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