Wastewater for PMI

The U.S. Environmental Protection Agency issued a final regulation in 1998 (63 FR 50388) that established standards for wastewater discharges for new and existing Pharmaceutical Manufacturing Industry (PMI) facilities. These regulations, the Pharmaceutical Effluent Guidelines found in 40 CFR Part 439, include nontraditional analytes and analytical methods specific to the pharmaceutical industry.

EPA has developed four different subcategories in the regulations based on the type of operations performed at the facility:

• Subcategory A - Fermentation Operations
• Subcategory B - Biological and Natural Extraction Operations
• Subcategory C - Chemical Synthesis Operations
• Subcategory D - Mixing, Compounding or Formulating Operations

The specific subcategory then determines the contaminants required for monitoring.

Eurofins has validated two of the specific methods required for determination of nontraditional analytes as part of the Pharmaceutical Effluent Guidelines. Coupled with other wastewater and drinking water methods (EPA Method 524.2 for example), these can provide monitoring for all the contaminants listed in the regulation. Eurofins has certification for these analyses through the NELAP program in Pennsylvania.

Methods for nontraditional contaminants:

• Method 1666 Revision A - Volatile Organic Compounds Specific to the Pharmaceutical Manufacturing Industry by Isotope Dilution GC/MS (for the purge-and-trap analysis).
• Method 1671 Revision A - Volatile Organic Compounds Specific to the Pharmaceutical Manufacturing Industry by GC/FID.

A baseline monitoring program as well as routine monitoring for a PMI wastewater is required under these regulations for many facilities. Eurofins has the equipment and experience to provide the analytical services needed for this program.