FDA Guidelines for Aseptic Processing

The Food and Drug Administration is the agency that oversees the manufacturing and production of food and medicines to ensure they are made in a safe manner. The guidelines for aseptic processing are challenging and must be followed to ensure the entire process is completed in a sterile manner as opposed to simply confirming sterility of the final product.

Definition

• An aseptic process is one that is designed to ensure that all activity that occurs after the initial sterilization maintains sterility, or cleanliness, throughout the downstream steps. For example, if the container that contains food is sterilized before it is filled, everything that occurs after the sterilization, including the process used to fill the container, must be sterile in order to minimize the risk of producing a non-sterile container of food.

Basic Requirements

• FDA guidelines require, at the most basic level, that documentation exists to prove the equipment and system used to manufacture a product maintained sterility throughout the production process. It also requires the packing material and equipment to be sterile. These guidelines are intended to ensure products are not contaminated and thus, safe for consumers.

Considerations

• The requirements for aseptic processing are very extensive and address a number of production areas, such as equipment, components, sterilizers, air flow systems and microbiological levels. Therefore, it is important to understand that all guidelines cannot be addressed by a single regulation from the FDA. When dealing with aseptic processing issues, it is best to seek advice from an expert who understands the complex system.