Question: “Can you speak to the requirements for monitoring Class D clean areas for viable and non viable particulate. The regulations don’t make it black and white.” Answer: The regulations surrounding viable and non viable monitoring of Class D clean areas…
Started in 1972 as a cloud microphysics company, PMS has grown into a solutions and thought leader for contamination monitoring and control within clean manufacturing facilities at sites around the globe.
A new challenge in Data Quality is approaching. The fourth industrial revolution (Pharma 4.0™) is the beginning of the “Smart Facility” era, where digitalization and automation will combine to reach very complex applications and life cycles. In this brand-new framework, Quality Experts will face the challenge of rethinking their roles and redesigning the Quality Systems of their pharmaceutical companies based on the concepts of Data Quality.
A syringe sampler represents the simplest delivery system for precisely delivering a sample to the particle counter. The precise motion of the syringe pump produces a steady flow of fluid that is free of pulsations…
The introduction of ISO 21501-4, in 2007, requires the adoption of Pulse Height Analysis (PHA) particle sizing technology and particle standard spheres with international traceability and uncertainty equal to or less than ± 2.5%. The standard defines two main goals: improve the instrument-to-instrument data correlation and improve the particle count accuracy.
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.
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…
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.
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.
Conventional approaches to contamination control are changing. They are being driven by the need to anticipate contamination events, rather than simply react to them, and new regulations are supporting this shift in thinking. Defining a Contamination Control Strategy (CCS) is unique for each process and requires an intimate understanding of both the process and how to implement an effective strategy. This blog series goes into depth on both topics.