OEL Fastrac Catalog

Collagen is a polypeptide comprising about one third of the total protein in mammalian organisms. Processed in a variety of ways, it is used in surgery as a hemostatic and as a repair and suture material. For cosmetic purposes, it can be injected into the dermis to correct scars and other contour deformities of the skin. Collagen implants are used to block tear outflow in the management of dry eyes. Intraurethral administration of collagen is also used in the treatment of stress incontinence. There has also been interest in the use of collagen by mouth to suppress the inflammatory process in rheumatoid arthritis, osteoarthritis, and scleroderma. Collagen is also used as a dietary supplement.

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.

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. 10-12 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 Collagen, just click the ADD TO CART button.

HBEL

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