Particle Measuring Systems

Particle Measuring Systems
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Particle Measuring Systems

 •  October 20

Our previous blogs on this topic discussed monitoring for certification and qualification. Today we address ongoing monitoring. The location of the monitoring points should be based upon a formal risk assessment (FMEA, FMECA or other risk analysis tools) using data from the certification and qualification testing. Other factors, such as equipment...

Particle Measuring Systems

 •  October 18

Our previous blog discussed monitoring for certification. Today we address monitoring for qualification. Learn more about the difference by downloading our paper Choosing the Most Suitable Particle Sample Point Locations in the Cleanroom. The qualification phase considers the risks to the quality of the finished product. Each activity must be...

Particle Measuring Systems

 •  October 17

Following the last blog which discussed three categories of monitoring requirements, we move onto monitoring specifically for certification. Cleanroom certification is based on ISO 14644-1, “Classification of air cleanliness by particle concentration” standards. The specifics of the assessment may vary slightly for FDA or EU GMP regulations, but...

Particle Measuring Systems

 •  October 16

As environmental system designers, we are often asked where to place sample points for particle monitoring, whether it be performed in a pharmaceutical cleanroom or clean device (RABS, isolator, etc.). The answer is not always straightforward. There are several guidance documents that offer advice on what processes need to be monitored, along with...

Ensuring that your liquid optical particle counter (OPC) is operating within its designed specification is critical to obtaining quality data. As data from OPCs becomes increasingly important to maintaining process control, it becomes more critical than ever for operators to have confidence in the data being generated. OPC data is frequently used...

Particle Measuring Systems

 •  September 28

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...

Particle Measuring Systems

 •  September 27

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. The technological advances can be segregated into these categories: Sterilization and Disinfection – This is a critical process...

Particle Measuring Systems

 •  September 26

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. In 2002, the FDA released its first progress report regarding...

Particle Measuring Systems

 •  September 15

When selecting an appropriate cleaning solution, consider the types of contamination that will have deposited onto the capillary from the most recent fluid sampled. For instance, if DI water was sampled last, bacteria, or particles are the most likely sources of contamination. If solvents were sampled last, optical hazing due to chemical...

Particle Measuring Systems

 •  September 14

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 calculation is performed using flow rates of 25–50...