Status of Waste Handling and Waste Treatment
Across the Pharmaceuticals Industry and
1977 Effluent Limitations
E.J. STRUZESKI, JR., Industrial Waste Consultant
National Enforcement Investigations Center
U.S. Environmental Protection Agency
Denver, Colorado 80225
BACKGROUND
NFIC-Denver (recently renamed NEIC, or the National Enforcement Investigations
Center) and which is an operating arm of the EPA, Office of Enforcement, Washington,
D.C, was called upon by a number of EPA Regions during 1974 to develop NPDES
discharge permits for pharmaceutical manufacturing installations. Effluent Limitations
Guidelines had not been promulgated for the Pharmaceuticals Industry. NEIC visited and
inspected 15 large bulk pharmaceutical manufacturing plants through the Northeast, the
Southeast and the Midwest. From careful study of waste control and treatment technology
available for the industry, appropriate technical rationale was formulated for NPDES
discharges across the industry. The NEIC 1974-1975 study succeeded in categorizing the
industry and developing effluent limitations under equivalent Best Practicable Control
Technology, 1977 conditions. This presentation at Purdue is a condensation of a larger
report titled "Waste Treatment and Disposal Methods for the Pharmaceutical Industry"
published by NEIC in February 1975 (1).
The large NEIC report is divided into Industry Categorization, Process Description,
Waste Characterization,Waste Parameters of Significance, Waste Recovery and Control,
Development of Effluent Limitations and Case Histories. The paper today will focus on the
different categories of plants; characterization of wastewaters from major fermentation and
synthesized organic chemicals manufacturing activities; waste parameters of prime
importance; available practices industry-wide; model and exemplary treatment systems for
the industry; and lastly, recommended effluent limits.
INDUSTRY CATEGORIZATION
Classes of "bulk" pharmaceutical final products have been recently defined by the
Kline Guide in 1974 and these are shown in Table I. This is only one of many possible
descriptions for the industry. Bulk pharmaceuticals are manufactured by a wide variety of
processes, including chemical synthesis, fermentation, extraction, and other complex
methods. From the standpoint of waste handling and treatment, unfortunately the Kline
Guide and all previous definitions do not offer a suitable catgorization of the industry (2,3,
4).
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