OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to cefazolin sodium (CAS RN 27164-46-1) and cefazolin sodium hydrate (CAS RN 115850-11-8). Cefazolin is indicated for the treatment of susceptible bacterial infections including genital infection, bone and joint infections, skin and skin layer infections, pneumonia, respiratory tract infection, sepsis and urinary tract infections. Cefazolin sodium is a semi-synthetic cephalosporin that specifically targets bacterial cell wall synthesis and demonstrates bactericidal activity against most strains of gram-positive aerobes including Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus agalactiae, Streptococcus pneumoniae, and Streptococcus pyogenes, as well as gram-negative aerobes such as Escherichia coli and Proteus mirabilis. Resistance to cefazolin has been demonstrated in methicillin-resistant staphylococci, many strains of enterococci, and most strains of indole positive Proteus (Proteus vulgaris), Morganella morganii, and species of Enterobacter, Serratia, and Pseudomonas.

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 Cefazolin, just click the ADD TO CART button.

HBEL

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