Parenteral drug products validation

Parenteral Drug Association. Validation of Aseptic Filling for Solution Drug Products, Philadelphia, 1980. 

Parenteral drug products are required to be sterile. There are principally five different ways to sterilize a product. These are steam, dry heat, radiation, gas and filtration. Selection of which method to use is based on the product that requires sterilization. For example, protein-based drugs are heat-sensitive, so the normal means for sterilizing these products is filtration. The rationale for sterilization validation is to show the reduction in microbial load or destruction of biological indicators. 

According to 211.113 Control of microbiological contamination, pharmaceutical manufacturers need written procedures describing the systems designed to prevent objectionable microorganisms in both nonsterile and sterile drug products. All sterilization processes used to manufacture parenteral drugs need to be validated. 

U.S. Department of Health and Human Services (DHHS) (1987), FDA guidelines on validation of the Limulus amoebocyte lysate test as an end product test for human and animal parenteral drugs, biological products and medical devices, DHHS, Rockville, MD. 

Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices Food Drug Administration, December 1987. 

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