When requalifying operating rooms certain physical parameters are recorded including air velocities, air volumes, air exchange rates, etc. to determine the values for ISO 14644-3. First, the required room data are recorded: length, width and height. If there are recesses, these must also be documented accordingly. From this we first calculate the room volume. Next […]
Should Anaerobic Cultures Be Part of GPT?
Anaerobic environmental monitoring is not a routine process, but is occasionally performed to detect potential anaerobic microbial contaminants, particularly those related to contamination by personnel.
Cleanroom Action and Alert limits
You’re going to have a high stream of data if you want a fast response to contamination events. Decide how long you want your samples to run to determine how fast. One minute samples are an immediate indicator that aren’t completely overwhelming…
Best Particle Counter for Sampling 5.0 μm Particles
As the aerosol particle counting experts, Particle Measuring Systems recommends against the use of 0.1 CFM particle counters to sample and monitor 5.0 μm particles. Instead, use a 1.0 CFM flowrate model like the Lasair® III particle counter to provide an adequate sample for the detection of 5.0 μm particles.
VHP Resistance and IsoAir® Pro Series Particle Counters
Vaporized Hydrogen Peroxide is a strong oxidizing agent and has been proven as a sterilizing agent in enclosed filling isolators for many years. As the increase of applications using isolators increases, so does the need for robust sensors capable of withstanding these environments. IsoAir® Pro Remote Particle Sensors contain an internal flow path that is designed to be resistant to the harmful effects of VHP.
Acceptable Particle Losses in Transport Tubing
…any loss can be deemed to be unacceptable. However, let us look at the uncertainties, the acceptable errors for particle counting…
Define Alert and Action Limits with the Latest Guidance
The transition to a continuous monitoring system now continuously demonstrates adherence to control parameters (which you use to define alert and action levels), and only instances…
Catching Up with GMP Requirements
…current good manufacturing practices (GMPs) and how they can be applied to a continuous monitoring system installed within a facility. Quality and Production teams can then establish new monitoring understandings and harmonize with standards.
How Particle Counters Work: The Technology
Regardless of manufacturer, the technology behind these devices uses the principle of light scattering. In this blog, we look inside the equipment to see how particle counters work.
How Particle Counters Work: The Tiny Things We Can’t See
…inside a cleanroom we could measure flakes of skin, small pieces of silicon or metal, or fungal spores… Most particles are non-uniform in structure, and this poses a question: How is the size qualified?
