This paper reviews the prevailing myths regarding steam sterilization currently prevalent in
the pharmaceutical industry. It updates an earlier article by the same authors on the that …

The author clarifies the definition and objectives of overkill sterilization for steam sterilization
cycles. Current sterilization practices are reviewed and the validation difficulties associated …

In recent years the Parenteral Drug Association has issued several technical reports that
had a significant impact on the validation of steam sterilization. They provide more …

This article illustrates a qualification–validation strategy for moist heat sterilization and briefly
discusses the sterility concept and common sterilization principles. In Part I, the authors …

Steam sterilization has been used for more than a century to sterilize items that can
withstand moisture and high temperature. Steam is water in the vapor state; therefore, it is …

This article illustrates a qualification–validation strategy for moist heat sterilization and briefly
discusses the sterility concept and common sterilization principles. In Part II, the authors …

In practice it is claimed that load characteristics influence a surface steam sterilization
process. To the best of our knowledge, no information on this topic has been found in the …

This chapter provides a basis for understanding sterilization using moist heat and the
sterilizers employed. It focuses on parts, components, and other items that need to be …

The FDA has issued proposed regulations to require that manufacturer's evaluate the “steam
sterilizability” of parenteral products. There are many different ways to assess sterilizability …

Terminal sterilization is considered the preferred means for the production of sterile drug
products, as it affords enhanced safety for the patient because the formulation is sterilized in …