The efficient mass production of pharmaceuticals requires scientifically replicable
measurements. The measurements, in turn, must be capable of description in words and …

The following paper was presented at the 1999 PDA International Conference in Tokyo,
Japan February 24, 1999. The paper was written in response to the recent well-publicized …

It is widely recognized that the level of particulate matter in an injectable product is one
measure of quality, directly reflecting the success with which the manufacturer applies good …

This Stimuli article provides a history of visual inspection practices and requirements for
parenteral products in the United States. It includes a sampling plan and test for products …

A procedure to permit objective comparison and thus validation of alternate particulate
inspection techniques has been developed and is described. This procedure is based upon …

To facilitate more rapid application of automated particulate inspection systems, biophysical
foundations for the industry standard manual inspection have been traced. This theoretical …

Particulate matter (PM) associated with pharmaceutical systems is in large part unwanted
contamination in sterile products for which there are compendial guideline methods and …

Most pharmaceutical products are specified to be essentially free of visible particles and
there are limits on the number of subvisible particles allowed. The FDA requires that …

The international drive to achieve higher quality and improved cost effectiveness in
parenteral products has achieved an apparent concensus concerning the utility and …

Regulatory monographs in Europe and the United States require drug products for
parenteral administration to be “practically free” or “essentially free” of visible particles …