The HandiLaz® Mini II handheld particle counter offers a powerful and nimble solution for pre-certification steps, identifying potential contamination hotspots, and troubleshooting high particle areas.
Particle Measuring Systems has designed a particle monitoring process for powder filling that satisfies current regulatory standards and eliminates a particle counter purge cycle.
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 […]
Continuous viable air monitoring is now a consideration, or even a recommendation o 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 […]
Particle Counter Data Remote Access, 21CFR11 Electronic Signatures…. The new normal is here. Companies want to protect their employees, keep pharmaceutical manufacturing running, while working efficiently and effectively and getting product to market safely and quickly. This presents a wide range of challenges that we did not face at the beginning of 2020. Fortunately, Particle […]
Part 3 of 3 part blog on : Cleanroom Classification – Qualification – Monitoring Per EU GMP Annex 1, rev 12 draft There is little overlap with cleanroom monitoring and qualification and classification as seen in the image here: The goal of cleanroom monitoring is to assess the potential contamination risk of the product. […]
The cleaning and disinfection of a pharmaceutical fill line & surrounding areas is a critical component of contamination control. We all think we are familiar with the principles of cleaning protocols, but it is deceptively easy to get this form of control wrong without applying the standards of QbD to the new equipment and facility […]