Completely revised and updated to reflect the significant advances in pharmaceutical
production and regulatory expectations, this third edition of Validation of Pharmaceutical …

This book focuses on sterilizing grade filters in the biopharmaceutical industry, emphasizing
practical applications of universal and dependable operational protocols, integrity testing …

The SIP (sterilization-in-place) concept has arisen in the industry as a result of the need
tosterilize equipment that is either too large or too inconvenient to place in either an …

This chapter starts with a historical overview, description of sterile filtration applications, and
performance requirements. Special attention is paid to the sterilizing final fill application for …

Pharmaceutical water systems contain very low assimilable organic carbon and present
significant physicochemical challenges to microorganisms. Bacterial contamination of …

Sterilization is a critical process in the preparation of many drug products. Its execution and
validation are addressed in numerous regulatory, pharmacopeial, and industry documents …

Isolator technology can be used in clinical product formulation and filling facilities to ensure
environmental control and reduce contamination risk during aseptic processing. Key …

Publisher Summary This chapter focuses on the preparation and filling of injectable solid
bulk pharmaceutical formulations. The material presented is general in nature but with …

Existing techniques for sterilizing equipment using pressurized steam are discussed.
Methods for confirming the sterility of equipment are considered. A method for determining …

The intent of this chapter is to review the salient features of process validation relative to the
preparation of sterile dosage forms. The introduction of process validation to the parenteral …