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 …

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 …

Aseptic handling is the procedure to enable sterile products to be made ready to administer
using closed systems (EU Resolution CM/Res (2016) 2). Microbiological monitoring (MM) …

Every person involved in pharmaceutical product manufacturing has the responsibility to
assure the quality of the product being produced. The aim of this paper is to validate quality …

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

Monitoring of microbiological quality in the pharmaceutical industry is an important criterion
that is required to justify safe product release to the drug market. Good manufacturing …

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 …

Introduction 'Aseptic handling is the procedure to enable sterile products to be made ready
to administer using closed systems'(EU Resolution CM/Res (2016) 2). Microbiological …

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 …

Environmental monitoring represents an integral part of the microbiological quality control
system of a pharmaceutical manufacturing operation. However, guidance documents differ …