OEL Fastrac Catalog

The trade name terminology, nylon, has been firmly established as applying only to polyamides polymerized from unsubstituted, nonbranched aliphatic monomers. Unfortunately, variations of these names are dispersed throughout the literature, such as nylon 6/6, 66-nylon, 6,6-nylon, and 6-6-nylon, all indicating nylon-66. The numbers added to the word “nylon” are indicative of the number of methylene groups (wherein the acid carbonyl can be counted as a theoretical methylene) in a monomer. Nylon analogues with two numbers added to the name represent polyamides synthesized from two distinct monomer units. Nylon-66, for example, is the polyamide synthesized from hexylenediamine and adipic acid (wherein each monomer has six methylene groups). Nylon-66 is also known as polyamide-66 (PA 6,6). Nylon-66, nylon-11, nylon-12, nylon 6/12, and nylon-6 have been approved by the Food and Drug Administration (FDA) as indirect food additives used for food contact surfaces. Nylon- 66 and nylon-6 are used in nonabsorbable surgical sutures, which are FDA-approved medical devices. Nylon ingredients, such as nylon-6, are used as bulking and opacifying agents in cosmetic formulations.

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 Nylon-66, just click the ADD TO CART button.

HBEL

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