Particle Measuring Systems believes that in the long run the periodic re-evaluation of the EM program will be enforced by authorities, but at the moment it seems the existence of an EM program is enough.
21 CFR Part 11 and Going Paperless Commonly Asked Questions
The original raw data is composed of the data and information stored in the system that generates the report. In your case, the computerized system is the raw data source that generates the printout and therefore, the raw data contained in this system must be available for data accuracy control.
Intel Case Study: Ultrapure Water UPW Contamination Control / 20 nm Particle Counting
Glen Slayter, Intel and Dan Rodier, Particle Measuring Systems (PMS) presented this paper at the 2020 Ultrapure Micro event. This Intel case study discusses the benefits and challenges of monitoring particles in ultrapure water (UPW) down to 20 nm. The presentation was the recipience of the #UPM2020 best presentation award. Only Particle Measuring Systems has proven […]
FMEA Commonly Asked Questions
When you perform your own FMEA, not only should you rank each value for probability, severity and detection, you should provide a rationale for choosing each value. Regulatory authorities need to understand your scientific rationale for the value chosen.
USP 1116 Commonly Asked Questions
Even if contamination recovery rates (CRRs) are adopted as a way to analyze microbial contamination, <1116> emphasizes that for an ISO 5 cleanroom, any excursion of >15 CFU should also be investigated.
COP26, Giki, and our Roadmap to Net Zero
To highlight the importance of COP26 Particle Measuring Systems is encouraging involvement from our employees to emphasize the role we can play individually and as a team in lowering our footprint. As part of our sustainability commitment, all Particle Measuring Systems employees have been offered the Giki app to help them understand their individual carbon […]
The Steps of a Risk Assessment for an Aseptic Filling Line
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…
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.
