10 Tips to Safeguard Your Cleanroom Through Proactive Contamination Monitoring
Cleanroom Standards, Classification and Compliance – Quick-Reference Guide
Particle Measuring Systems has created these Cleanroom Standards, Compliance & Classification quick-reference cards. A free quick-reference tool designed to help you navigate cleanroom standards with ease.
Compressed Gas Systems in Aseptic Manufacturing
Discover the importance of compressed gas risk assessment in pharmaceutical manufacturing. Learn how to ensure product quality and compliance through effective management of compressed gas systems, including their design, operation, and monitoring.
Compressed Gas Contamination: Guidelines for Control in Aseptic Manufacturing
Ensure the integrity of your manufacturing processes with our comprehensive guide on maintaining the cleanliness of compressed air systems. Discover essential guidelines for identifying contaminants, monitoring practices, and preventive maintenance strategies to meet regulatory standards. Learn how Particle Measuring Systems can support you in achieving optimal air purity and safeguarding product quality.
Optimizing Microbial Air Sampling to Reduce False Positives in Cleanrooms
In this blog, we’ll explore how modern innovations, like the BioCapt® Single-Use microbial impactor, can enhance microbial air sampling efficiency while reducing the risk of false positives in cleanrooms.
Microbial Sampling Criteria
In the pharmaceutical manufacturing industry, ensuring sterility and minimizing microbial contamination are critical for maintaining product quality and safety. Microbial sampling is a key component of environmental monitoring, and understanding the optimal criteria for sampling can significantly impact the effectiveness of sterility assurance programs. Learn about optimal microbial sampling criteria here.
Contamination Control Strategies for Innovation FAQ’s
In the pharmaceutical industry, maintaining stringent contamination control is not just a regulatory obligation but a fundamental aspect of ensuring product safety and efficacy. The EU GMP Annex 1 outlines the importance of a Contamination Control Strategy (CCS) for sterile drug products, emphasizing the need for a structured approach to manage risks and maintain compliance. We recently hosted a webinar discussing these strategies in detail. To help navigate this complex field, we’ve compiled a list of frequently asked questions from our experts.
IT Outages and Continuous Cleanroom Monitoring During with FacilityPro®
Our Facility Pro® environmental monitoring system showcases exceptional performance during internet outage events, ensuring uninterrupted and continuous cleanroom monitoring and control. Facility Pro is a vital component of our Facility Monitoring Systems (FMS) product line, integrating sampling, reporting, and data retention of particle, microbial, and environmental data.
Applying Appropriate Limits in Cleanroom Monitoring
Protect the cleanliness of your environment by utilizing limits in cleanroom monitoring, including standards like ISO 14644-1:2015 and the EU GMP Annex.
Why is 50% the Limit for Particle Counting Efficiency Sizing Thresholds?
Particle counting efficiency is crucial in particle measurement, especially when using optical particle counters. This term denotes the likelihood of precisely detecting and enumerating particles within a specified size spectrum. In this context, the term “counting efficiency” represents the ability of the particle counter to quantify particles of a given size accurately. It measures the instrument’s performance, indicating how effectively it can detect and count particles of various sizes.