Particle Measuring Systems has designed a particle monitoring process for powder filling that satisfies current regulatory standards and eliminates a particle counter purge cycle.
Powder Filling: The Monitoring Process and its Background in Regulation
Particle Measuring Systems has designed a particle monitoring process for powder filling that satisfies current regulatory standards and eliminates a particle counter purge cycle.
Choosing the Right Complete Contamination Control Solutions Provider
When choosing a particle counting contamination control provider for your controlled environment, much emphasis is put on the instruments (particle counters). But there are other equally important factors. When you buy instruments for long-term use, you are entering into a long-term partnership. Make sure it’s the right fit for you. Here are some factors to […]
Argonaut Manufacturing Services and Particle Measuring Systems Partnering for Top Tier Results
All companies have a reason for existing and a focus on what they do best. That is why most companies bring in experts to partner with for areas outside their expertise. “Argonaut Manufacturing Services has been successful by really focusing on its core business. Outside of that we rely on our key partners”, says […]
Data Trending Requirements Annex 1, Rev 12
Data Trending and Alert/Action Levels definition are new requirements in the latest EU GMP Annex 1, Revision 12 draft. Trends allow you to quickly and easily identify changes in your cleanroom data and leverage this to make effective decisions, changes, and adjustments often before problems occur. Here we discuss three key components in the latest […]
Continuous Viable Air Monitoring per Annex 1 Draft, Rev 12
Continuous viable air monitoring is now a consideration, or even a recommendation in the new sections of Annex 1 draft, rev 12. Here I discuss this as well as the overall environmental monitoring requirements as part of Particle Measuring System’s series on the newest Annex 1 draft. Learn what Annex 1 is saying it will […]
Accessing Cleanroom Data in the New Normal
Accessing cleanroom data and creating reports was challenging and time consuming before the “New Normal” working environment. In today’s world this has become virtually impossible. However, with Particle Measuring Systems’ PharmaIntegrity data management solution you can access data from any of your manufacturing facilities, anywhere in the world easily. Plus, the data is already in […]
High Flowrate Monitoring Uses and Benefits
Sampling standards keep managers of environmental monitoring (EM) on their toes. Read this blog to learn more about how to use high flowrate monitoring to make the most out of your EM practices in less time.
The New Normal & Data Integrity eSignatures
Imagine a world where giving an getting approvals was easy for all to accomplish and equally easy to track and access. Such a world would work very well in the “new normal” when employees are frequently remote and unavailable for paper signatures. With Particle Measuring Systems’ PharmaIntegrity data management system you get a 21CFR11 compliant […]
Remote Audits in a New Normal World
Covid-19 has brought the need for tomorrow’s way of working crashing down on us today. This “new normal” means that many people will be working remote as frequently as possible. This presents challenges, including how to conduct an audit. Fortunately, there is one solution available today to solve this “new normal” problem when it comes […]
