The sterility test has been utilized for many years to formally support the sterile release of
products terminally sterilized by moist heat and other sterilization modalities. It is well-known …

This review article will provide general guidance to product development scientists for the
justification for the use of aseptic filling for sterile injectable products in the place of terminal …

The design, validation, and monitored delivery of the sterilization process, and validated
post-process integrity of the product package are the primary means to assure the end-use …

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 …

Terminally sterilized products are typically released for market distribution on the basis of a
satisfactory review of the sterilization cycle records and compliance with sterility test results …

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 …

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

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 …

ABSTRACT A decision scheme for determining the capability of a finished product dosage
form to be terminally sterilized was presented and followed for a heat-sensitive, oxygen …