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

The transition from traditional growth-based microbial detection methods to continuous bio-fluorescent
particle counting methods represents a paradigm shift, because the results will be …

The Process and Environmental Monitoring Methods Working Group, composed of members
from industry and instrument manufacturers, met with the FDA Emerging Technology Team …

Investigations into environmental monitoring (EM) excursions can be prolonged and do not
always result in clear root causes or corrective and preventative actions. This article outlines …

The current compendial sterility test has a 14-day incubation time and is often the time-limiting
step in the Assess and Release Process of pharmaceutical products. There is an ever-…

Adopting emerging microbiological methods is often desirable because it enables more
advantageous, real-time monitoring practices. However, when the newer method measures …

… Phil Villari is an Associate Principal Scientist at Merck & Co., Inc., in Rahway, New Jersey.
Villari is a member of the BioPhorum ARMM BFPC Team and the PEMM Working Group. …

The analyzing power in inclusive charged pion production has been measured using the 200
GeV Fermilab polarized proton beam. A striking dependence in x F is observed in which A …

A new polarized-proton and -antiproton beam with 185 GeV/c momentum has been built at
Fermilab. The design uses the parity-nonconserving decays of lambda and antilambda …

THIS Volume requires no regular preface, for it only contains seven essays selected from
the great number I have written on various topics and at different times. But I have tried to …