The primary purpose of an environmental monitoring program is to provide oversight for
microbiological cleanliness of manufacturing operation and document the state of control of …

We establish alert and action limits for environmental monitoring programs in cleanrooms in
the pharmaceutical industry. Heavily skewed count data, which exhibited both …

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 …

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 …

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) …

In the present work we compared different calculation approaches for their ability to
accurately define microbiological control levels based on historical data. To that end, real …

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

Traditional techniques for calculating control limits for processes with discrete responses are
based on the Poisson distribution. However, for many processes, the assumption of a …

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 …

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 …