Particle Measuring Systems (PMS) articles

Abstract
The role of quality systems in pharmaceutical organizations has grown faster than any other function during the last 15 years. During this period, a small group dedicated to traditional Compliance grew and expanded to include Quality Experts in areas such as validation, product release, operations, sterility assurance, and other specialized functions. Creating a deeper quality connection between manufacturing and engineering has always been the aim of that growt

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

Welcome to the world of liquid particle counting and syringe sampling!
If you’re new to liquid particle counting, you might not know anything about how we know if liquids are clean. One method to determine a liquid’s cleanliness is syringe sampling.

Over the previous five Blogs in this series we have discussed the critical quality attributes to consider in a robust Quality by Design plan for the construction of a new Isolator/RABS fill line. The primary topics we explored are: Regulatory, Surround Areas, Cleaning, Process Interventions and Environmental Monitoring. Here we will talk about when these actions should take place, who should perform them, and what documentation and other activities may be necessary to ensure that you enjoy th

Set up and Process Interventions on a fill line are two of the most difficult operations to overcome if they are not designed to properly minimize impact to the product and the environment in the early stages of Isolator/RABS design. Set up of the fill line poses a significant risk of introduction of contaminants because many materials are introduced to the clean area by the operators.

These can be minimized with a thorough Process Optimization study early in the project. <