In the meticulous world of cleanroom operations, efficiency isn’t just a goal—it’s a necessity. From real-time monitoring to paperless processes, here are three key strategies to elevate workflow and streamline operations. 1. Real-time Monitoring: Contamination is inevitable, but swift detection and response can mitigate its impact. Real-time monitoring and continuous microbial monitoring bridge the gap between data collection and analysis, […]
Air Sampler impaction technology has been around for decades. However, the d50 is a little known aspect of air sampler technology design and it plays a critical role in air sample capture. Aerosol Impaction is the process in which particles are removed from an air stream by forcing the gases to make a sharp bend. […]
We talk a lot about data integrity, but what happens, in the real world, when US Food and Drug Administration (FDA) data integrity protocols are not met? In December, we got to see this scenario play out. Between November 22, 2022 and December 2, 2022, FDA inspectors visited a large pharmaceutical manufacturer’s facilities in India […]
21 CFR Part 11 outlines the federal requirements that help to ensure that electronic records are trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. 21 CFR Part 11 has 10 chapters over 3 subsections. These subsections are General Provisions, Electronic Records, and Electronic Signatures.
Particle Counter management is a critical process in ensuring particle counter health and data integrity. The accuracy of the data from particle counters is critical in regulated industries. Particle Counters should be calibrated regularly based on their use. Manufacturers recommend that Particle Counters are calibrated at a minimum on an annual basis.
Features to look for in your particle monitor to ensure compliance of your cleanroom Environmental monitoring lies at the heart of regulatory compliance for cleanrooms used in pharmaceutical, bio-pharmaceutical, and healthcare facilities. Facility managers need to understand what components are needed for a monitoring program, but they must also ensure the data they produce is […]
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