Freeze-Drying/Lyophilization Of Pharmaceutical & Biological Products, Revised and Expanded
Page 1 DRUGS AND THE PHARMACEUTICAL SCIENCES Executive Editor James Swarbrick …

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 …

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 …

Container closure integrity (CCI) testing is required by different regulatory authorities in
order to provide assurance of tightness of the container closure system against possible …

We developed several techniques for visualizing the fit between a stopper and a vial in the
critical flange area, a location typically hidden from view. Using these tools, it is possible to …

This article presents a new theoretical integrated modeling approach for calculating
container closure integrity (CCI) that concurrently accounts for both diffusion and …

The close relationship between a pharmaceutical preparation and its package is of major
concern to the industrial pharmacist. Faulty packaging of pharmaceutical dosage forms can …

A feasibility study was conducted for a sensitive and robust dye immersion method for the
measurement of container closure integrity of unopened prefilled syringes using …

The field of parenterals has seen substantial technical and scientific growth over the past
two decades, with the expectation of even greater activity during the last half of the 1980s …

The preference of Prefilled syringes is increased over all the vials as container closure
systems for liquid injections, when facilitated or self-administration is required. However …