Providing a well-written and easy-to-read review of the subject, this reference describes the
most recent breakthroughs in the validation and execution of testing schemes for parenteral …

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

Purpose. There is an increasing use in the pharmaceutical industry of barrier systems such
as transfer isolators, sterilisation tunnels and work station isolators. As Vapor Hydrogen …

A biological indicator is formed from two members (or a sheet with one portion folded onto
another portion) which are sealed together and form a pathway having three sections. One …

Biological indicators are provided for use in validating and routinely monitoring oxidizing
gas sterilizations. The biological indicators are based on Bacillus circulans spores that are …

The objective of this chapter is to present a planning guide for designing and implementing
aseptic processing for drug product manufacturing, for both clinical supplies and the …

Porcine parvoviruses (PPV) are known to be particularly resistant to many disinfectants used
to control other non-enveloped viruses. However, effective disinfectants used against PPV …

The contact surfaces for injectable drugs usually are of stainless steel, glass, or elastomeric
compounds that can be steam sterilized. Ideally, if possible, equipment surfaces that are not …

DEFINITION OF AN ISOLATOR The definition of an isolator is almost an existential question
for anyone who has to decide to buy or to design an isolator. The official definition is actually …

Sterilization processes may be applied in the pharmaceutical and medical devices
industries for three distinct activities: 1. Sterilization of products in their final containers. 2 …