FDA Aseptic Processing Guide

Asepsis is the practice of reducing or eliminating contaminants from entering a particular environment such as the operative field in surgery or in the manufacturing process of medicines. There are guidelines that have been created by the U.S. Federal Drug Administration that govern the manufacturing of sterile drugs and biological products with aseptic processing.

Qualified Personnel

• Individuals who work in the field of aseptic processing must be trained and qualified in order to carry out their job duties within this particular field. Each person involved within the manufacturing, processing, packaging and holding of a drug product is expected to have an education, training and/or experience. Employees must also obtain instruction with current good manufacturing practices (CGMP) as part of their training.

Building and Facilities

• Aseptic processes must be performed within a sterile environment and the buildings that are used to manufacture these goods must be designed to prevent contamination. Floors, walls, ceilings, surfaces and air filters are required to have specific cleaning, air filtration and disinfecting systems in place in order to produce the aseptic condition. Equipment must also be cleaned and maintained in order to adequately perform aseptic procedures.

Laboratory Controls

• Drugs that are manufactured using the aseptic process require testing inside of adequate laboratory facilities. These tests are conducted in separate areas for components, containers, closures and drug products to ensure that they meet certain requirements for quality, purity, identity and drug strength.