Pharmaceutical Client

Potent Drug Handling Facilities

Potent Drug Handling Facilities

Overview

Grumman/Butkus Associates completed two separate designs for a major pharmaceutical client that required facilities for handling potent compounds. Potent compounds are active in relatively low doses or concentrations; extreme caution must be taken in every aspect of the design and in the construction of a potent drug handling facility. Systems and construction materials are selected and applied to best protect the lab occupants and the environment from the effects of the compounds, as well as from chemicals and materials used for cleaning. Each facility is ultimately subjected to the scrutiny of the Food and Drug Administration in accordance with current Good Laboratory Practices (GLP). The HVAC systems were commissioned, qualified, and validated.

Features

  • Once-through air handling system (8,000 CFM) capable of maintaining space conditions at 68°F and 50% relative humidity.
  • Air distribution system providing 35 air changes per hour in potent drug handling areas.
  • Supply terminals with terminal HEPA filtration.
  • Low-level HEPA-filtered exhaust, extractor arms for "point of use" capture of compounds, and glove box isolation equipment. The exhaust system is designed with full redundancy.
  • Separate airlocks for personnel and materials.
  • Decontamination showers between potent drug areas and personnel airlocks.
  • Separate chemical drain systems for "contaminated" and "clean" discharge.
  • Utility panels for process-required services.