Pharmaceutical Manufacturing Industries (PMI) Analyses

We are a NELAC Certified Environmental Testing Laboratory

The United States Environmental Protection Agency promulgated the Pharmaceutical Manufacturing Effluent Guidelines and Standards (40 CFR Part 439) in 1976 and amended the regulation in 1983, 1998 and 2003. The Effluent Guidelines are incorporated into NPDES permits for direct dischargers, and permits or other control mechanisms for indirect dischargers for Pharmaceutical Manufacturing Industry (PMI) facilities.

The regulation applies to facilities organized into five subcategories:

A. Fermentation Products
B. Extraction Products
C. Chemical Synthesis Products
D. Mixing/Compounding and Formulation
E. Research

Advanced Analytical Technologies, Inc. is one of the few laboratories certified through the NELAP program for the analyses of non-potable water by EPA Method 1666 Revision A and EPA Method 524.2 as required by Pharmaceutical Manufacturing Effluent Guidelines.

For a long time Advanced Analytical Technologies, Inc. has been providing analytical services for PMI Analyses to many pharmaceutical companies, engineering firms, and municipal authorities.

The list of certified analytes includes:

EPA Method 1666A:
n-Amyl acetate
n-Amyl alcohol
n-Butyl acetate
Ethyl acetate
n-Heptane
n-Hexane
Isobutyraldehyde
Isopropanol
Isopropyl acetate
Isopropyl ether
Methyl formate
Methyl isobuthyl ketone (MIBK)
Tert-butyl alcohol
Tetrahydrofuran
m+p Xylene
o Xylene
EPA Method 524.2
Acetone
Benzene
Chlorobenzene
Chloroform
1,2-Dichlorobenzene
1,2-Dichloroethane
Methylene chloride
4-Methyl-2-Pentanone
Tetrahydrofuran
Toluene

 
Please contact us for further information