Automated non-viable particulate monitoring systems can significantly reduce sampling
costs while providing increased assurance that pharmaceutical products are free of …

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

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

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

Manufacturing pharmaceutical products is a highly controlled process, whether the end
product is aseptic, terminally sterilized, lyophilized, or even an originating bulk ingredient …

Microbiologic monitoring of controlled pharmaceutical and medical device manufacturing,
and pharmacy compounding processes, is mandated in numerous standards and guidelines …

Regardless of the type of pharmaceutical product manufactured, there are regulatory
expectations that environmental monitoring be performed. Monitoring of water systems …

Visible particulate matter contamination is responsible for the rejection or recall of numerous
batches of injectable product each year. The result is wasted time, effort, money, product 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 …

The availability of the probabilistic model of particulate inspection in sealed sterile
containers, first reported in 1979 (/), potentiated both a study of human inspection capability …