Control of the Aseptic Processing Environment

Abstract

Methods used by industry with applications to hospital pharmacy for maintaining an aseptic environment in production of sterile pharmaceutical products are discussed. A major source of product contamination is airborne microorganisms. The laminar-airflow workbench with a high-efficiency particulate air filter provides an ultraclean environment for preparation of sterile products. However, the workbench does not guarantee sterility of products and is not effective if not properly installed and maintained or if the operator uses poor aseptic technique. The laminar-airflow workbench should be tested for leaks, airflow velocity, and airflow patterns when installed, and the workbench should be checked periodically thereafter. The workbench should be placed in a cleanroom where traffic and air disturbances that might affect the laminar airflow are eliminated. A major source of airborne microbial contamination in cleanrooms is people. Personnel movement through an area and presence of personnel without lint-free, nonshedding protective garments increase the levels of microbial contaminants in an area. The transport of nonsterile products (bottles, boxes, paper products) into a cleanroom should be minimized. The cleanroom itself should be sanitized and should be immaculate. Microbial or particulate monitoring should be conducted in the cleanroom using a quantitative method, and corrective-action limits should be set. Hospital pharmacists should examine industrial sterile-processing techniques and apply them to the preparation of sterile products.