Data from particle monitoring in cleanrooms in pharma production applications is critical data. It is crucial that particle monitoring systems are properly supported. With advances in software and networking, remote assistance and service level agreements (SLA) vendor support contracts should enable pharma production to take full advantage of fast response times over the Internet by…
Data Integrity — Choosing Your Particle Monitoring Equipment
Data integrity risks are inherently proportional to the complexities of the processes and computerized systems where the data is sourced from. Particle counter data plays a critical role in the pharmaceutical product lifecycle. By selecting the right equipment and services, you can mitigate these risks and have more reliable data from a validated source. There is much discussion lately on the topic…
Selecting the Right Monitoring Instruments for Cleanroom Classification
One of the biggest challenges in any cleanroom is setting up a suitable monitoring program. Which instruments are used, how frequent samples should be, how much sampling is required, what guidelines need to be followed? All of these questions need a firm understanding of the different technologies capturing cleanroom air samples in portable particle counters…
Setting appropriate alarm limits in sterile manufacturing processes
Setting inappropriate Alert and Action alarms on your Environmental Monitoring System (EMS) could be a big contributor to lost revenue, longer downtimes, and a lot of discarded product. Misinterpretation of cGMP guidelines and an inadequate approach to the use of your EMS alarming functionality may set you up for failure right from the start. By…