This presentation describes technical subtleties and complexities associated with validating
the sterilization of closure systems. Also presented are areas of misunderstanding and …

Two biological indicators are routinely used by the Hospital Products Division to
demonstrate the sterilization of the closure-container interface. The use of a moist heat …

The container closure system for pharmaceutical products intended to be sterile is critical
and this criticality relates to the physical properties of the container closure system in that a …

Closures that form part of the container-closure system are an important component in the
packaging of sterile products. Container-closures maintain the sterility of parenteral …

A new approach is being tested for the microbiological monitoring of aseptic environments,
and improvements are being written in guidance for sterility assurance, as part of an active …

Conventional aseptic filling of drug product into vials ultimately includes a step that requires
time and travel from the stoppering stage to the capping/crimping stage. Lyophilized product …

Medical devices that contact the blood or other internal tissues, other than the alimentary
canal or other mucosa, are expected by medical practice to be sterile. Those devices that …

In the past, the packaging of pharmaceutical products often took little account of the
microbiological aspects of maintaining product integrity. This was especially true of …

To demonstrate maintenance of parenteral product sterility, container-closure integrity over
the shelf life of the product is critical. In the past, sterility testing has been used to ensure …

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 …