The risk assessment is a collaboration of many people that takes time and dedication. The analysis of the risk assessment is performed using a typical mathematical relationship (FMEA) that links the Risk Priority Index (RPI) with the probability of contamination (P), with…
Archives for October 2021
USP 788 vs 1788 – How do They Compare?
New flow imaging technologies and therapeutic protein solutions widened the scope of <1788>. Three primary technologies are discussed in each of the sub-parts of the guidance document…
Safe Vaccines
Part of Particle Measuring Systems’ role in making the world make the world cleaner, healthier & more productive As part of the Spectris PLC family of businesses, we aim to deliver value to society by providing solutions that make the world cleaner, healthier, and more productive. As part of Spectris, Particle Measuring Systems (PMS) supports […]
Answering your data integrity questions
Here, PMS takes the opportunity to answer your data integrity questions. From current security regulations to how to align best practices with PLCs, we’ve got you covered.
What is Batch In-Situ Particle Monitoring?
The portable batch ISPM system is mounted on a cart so that the sampler is above the fluid level in the sample vessel or bath. This positioning prevents the possibility…
