Normalized Data in Microbial Continuous Monitoring
Should I be concerned about normalizing data (CFU/m³) for grade A and B areas in Microbial Continuous Monitoring?
Knowledge Category: Regulatory
Ensuring Consistent Quality in Pharmaceutical Water for Injection (WFI) Systems
To safeguard product integrity and protect patients, disciplined preventive maintenance, practical risk assessment, and routine monitoring are essential across the system at every critical point of use. Together, these measures create a resilient, well-characterized water system that enables manufacturers to operate with confidence and maintain sustained control over their environments.
BioCapt Single-Use® Microbial Impactor Performance in Continuous Active Air Monitoring
Cleanroom environmental control and continuous active air monitoring are essential to sterile pharmaceutical manufacturing. Because agar plates, which are used in most active air sampling, can dehydrate during prolonged exposure or sampling, manufacturers must carefully manage exposure times and environmental conditions. Download this paper to see how the BioCapt Single-Use® (BCSU) microbial impactor helps overcome these limits and supports reliable cleanroom control.
Aerospace and Defense Particle Counting
Typical ISO class cleanrooms in industries such as Pharmaceuticals or Semiconductors necessitate a standard set of demands for particle counting instrumentation and accessories to help customers achieve the required specifications outlined by regulatory committees. The Aerospace and Defense industries need to meet their own unique set of requirements that are often more variable and customer-specific than in other markets; this is something Particle Measuring Systems instrumentation and expertise can support.