Archives for September 2017

Our last blog on this topic discussed improved biological efficiency by design. Today we will discuss the statistical corrections for viable particle reading accuracy. The values in each table are calculated from Feller’s formula (Feller, 1950): Pr = N [1/N + 1/N – 1 + 1/N – 2 + 1/N – r + 1]. The […]

Our last blog on this topic discussed the technological advances that have changed sterility assurance. Today we address rapid microbiology methods and the impact on sterility assurance. Environmental Monitoring (EM), particularly in Pharmaceutical manufacturing facilities, where the risk of microbial contamination is controlled through aseptic processing, comprises both physical and microbiological test methods. Nonviable particulate […]

Following the last blog, which discussed the regulations and guidelines surrounding advances in sterility assurance, we move on to discuss the technological progress that has made advances in sterility assurance possible.

Over the last decade significant technological advances have been made regarding the sterility and quality of new drug and microbiological products. New treatment and advancements in medical devices have led to an increase in quality of life and life expectancy for millions of patients.

Following the last blog discussing the principles of Feller’s table of statistics, we move on to discuss improved biological count by impactor slit design. By using impactor slits it is easier to determine false positives. For example, the BioCapt Microbial Impactor is used for microbial air sampling in cleanrooms and associated controlled environments. The slits on the […]

Microbiologists rely on the Feller table to correct for undercounting of biological activity. The “Table of statistical corrections according to Feller” is based on the principle that as the number of viable particles — colony forming units (CFUs) — impact on an agar plate increases, the probability that viable particles will enter unoccupied space decreases. […]

Particle Measuring Systems (PMS) and Novatek International form strategic partnership to bring a unique, integrated, contamination control solution to the life sciences industry.

September 14, 2017, Boulder, CO – Particle Measuring Systems (PMS), a global expert in sterility assurance, and Novatek International, the leader in regulatory compliant data management software, today announced a global partnership providing a fully integrated and comprehensive software and hardware solution towards a risk-based approach for the environmental monitoring in controlled manufacturing processes.

This is a basic guide to LiQuilaz and LiQuilaz II particle counter maintenance. Occasional cleaning of the liquid capillary is required and it is the customer’s responsibility to perform the cleaning when necessary.

The need for capillary cleaning and the general health of the capillary can be improved by continuously running water through the system when it is not in use. In addition, never allow the capillary to dry out, as this could permanently damage the capillary.

This is a basic guide to LiQuilaz and LiQuilaz II particle counter maintenance. Occasional cleaning of the liquid
capillary is required and it is the customer’s responsibility to perform the cleaning when necessary.

The need for capillary cleaning and the general health of the capillary can be improved by continuously running
water through the system when it is not in use. In addition, never allow the capillary to dry out, as this could
permanently damage the capillary.