The results of a proof-of-principle study demonstrating a new analytical technique for
detecting microbial growth directly in pharmaceutical containers are described. This …

USP< 1207.1> Section 3.5 states that “A deterministic leak test method having the ability to
detect leaks at the product's maximum allowable leakage limit is preferred when …

The rapid, accurate determination of headspace oxygen and moisture in various
pharmaceutical packages is important for both product packaging development and the …

Tunable diode laser absorption spectroscopy (TDLAS) was evaluated on its potential to
detect bacterial growth of contaminated media fill vials. The target was a replacement …

This paper provides recommendations for quality oversight, manufacturing operations, and
industry perspective of regulatory expectations to enable aseptic facilities to move toward …

The cleanliness of changing rooms used to access pharmaceutical cleanroom facilities is of
considerable importance. This ensures that the changing environment and the act of putting …

The ability to rapidly screen samples for the presence of pathogens offers many advantages.
From a security standpoint, the rapid classification of samples as pathogenic or non …

Transmission holography has been used to translate the Knapp and Kushner
probabilistically defined “Reject Zone” for particulate contamination in parenteral products …

The accurate determination of headspace oxygen levels in common pharmaceutical
packaging configurations presents several analytical challenges in terms of both sampling …

As described in USP< 1207>, the container closure integrity (CCI) of a pharmaceutical
package must be maintained throughout the product lifecycle to ensure sterility and stability …