Particle Monitoring System Articles & Analysis
8 articles found
The determination of collagen molecular weight is a technique used to determine the molecular weight of collagen, a complex protein. Collagen is one of the richest proteins in animals, mainly found in the skin, bones, tendons and connective tissue. Due to its key role in cell structure and tissue regeneration, accurate determination of the molecular weight of collagen is of great significance to ...
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 this purpose in a variety of ways. One of ...
Who Who performs the QbD evaluations and makes the recommendations to ensure it is implemented at the equipment design phase may be one individual, a group or a combination of experts working together from different consultation perspectives; including, but not limited to: PMS Advisory Services – Including any or all of the following services: Advisory Services – to help you ...
In the next blog in this series we will examine what Environmental Monitoring on a new fill line looks like with and without QbD implemented at the design phase. These examples come from real-world applications experienced by the Particle Measuring Systems’ Advisory Services Team. Our team has over 70 years of collective experience working ...
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 at the design phase. There are many things to consider from ...
The area surrounding an isolator/RABS pharmaceutical fill line can be a difficult area to control. There are many functions and moving parts that support the fill operations that occur in the controlled area just outside the controlled area that can greatly impact the process itself. Below are several pitfalls to be aware of that might be thwarting your contamination control efforts if you are ...
What does Quality by Design (QbD) in the design of clean manufacturing equipment and processes look like? This might be easier to visualize if we look at it from the perspective of the absence of it. Design and optimization based on only the engineering point of view, and not on understanding of the process, often leads to unintended impacts on the end-use of the equipment. These unintended ...
The following is the summary of a noteworthy discussion from the 2019 GMP Academy Master Course – Particle Measuring Systems, Rome, Italy The first GMP Academy Master Course took place from November 26 – 28 at Particle Measuring Systems (PMS) in Italy. International experts met to share their knowledge and expertise ...