A statistically robust set of rules is proposed for trending excursions in environmental
monitoring data. These rules were designed to minimize false alarms when the process is in …

Environmental monitoring programs for the oversight of classified environments have used
traditional statistical control charts to monitor trends in microbial recovery for classified …

Abstract United States Pharmacopeia (USP)< 1116>" Microbiological Control and
Monitoring of Aseptic Processing Environments" approaches analysis of environmental …

In manufacturing settings, control limits are often set using a three-sigma rule (ie, three
estimated standard deviations above and below the estimated mean). More sophisticated …

Alert levels are always lower than action levels and are established based on historical and
qualification trend data and periodically reviewed. One should also consider environmental …

Abstract The US Food and Drug Administration 2004 Guidance and the Code of Federal
Regulations (CFR) governing the manufacture of pharmaceutical products (21 CFR 211) …

Microbiological monitoring of “Clean rooms” generates a large number of results, which are
used, in the first instance, to determine that product or patient have not been exposed to an …

The qualification, or requalification, of an aseptic manufacturing facility depends in large part
on the demonstration of controlled microbial conditions. The following are several areas …

To determine the relationship between the sampling time of the environmental monitoring,
ie, viable counts, in aseptic filling areas and the microbial count and frequency of alerts for …

Purpose Little attention has generally been given to non-sterile pharmaceutical
manufacturing, because these products represent less microbial contamination risks …