In this 2-part blog series, we hear excerpts from an interview between Frank Panofen, Global Marketing Manager at Particle Measuring Systems and Rizwan Chaudhrey. They talk about how Particle Measuring Systems rapidly adapted to the change in our customers’ needs for manufacturing support around the world in 2020 and how they think the industry will be different because of it in 2021 and beyond.
Remote Validation and Training services during the Pandemic: A Success Story
Remote working, and allowing fewer vendors onsite can make projects very challenging, sometimes pausing projects indefinitely. David Quelle, GM of PMS Brazil, discusses one example where the Particle Measuring Systems’ team was able to work with a customer to remotely validate their FaciltyPro Environmental monitoring system & MiniCapt Monitors and conduct training.
Argonaut Manufacturing and PMS, A Contamination Monitoring Success Story!
When Argonaut Manufacturing was setting up their new state-of-the-art fill line they wanted the best contamination monitoring solution in a tight timeframe. Watch how Argonaut and PMS worked together to complete the mission.
Handheld Particle Counter Benefits: A Wealth of Applications
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.
Handheld Particle Counting Benefits: Regulation and an Evolving Industry
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.
Argonaut Manufacturing Services and Particle Measuring Systems Partnering for Top Tier Results
All companies have a reason for existing and a focus on what they do best. That is why most companies bring in experts to partner with for areas outside their expertise. “Argonaut Manufacturing Services has been successful by really focusing on its core business. Outside of that we rely on our key partners”, says […]
Contamination Control Strategy and Annex 1
Science vs standardization: justification vs blindly following rules. The new auditors’ expectations for a cleanroom monitoring plan Annex 1 requires designing an effective contamination control strategy (CCS) based on a scientific assessment to understand the process and to apply risk management principles. The latest Annex 1 draft frequently uses the terms “risk” “justify” and “strategy”, […]
How to Achieve Quality by Design (QbD) in a new Pharmaceutical Fill Line: Intro and Regulatory (Series Part 1 of 6)
In this blog series we will examine what a new fill line looks like with and without QbD implemented at the design phase. We will study each critical area of the fill line and the activities necessary to effectively bring the control features into effect. 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 in and advising cleanroom users around the world.
Annex 1 Single Use Systems (SUS) Requirements & the BioCapt Single Use Impactor
The new EU GMP Annex 1 rev 12 states, regarding single use systems: Chapter 8 . Production and Specific Technologies Paragraph : Single use systems (SUS) Annex 1 rev Dec 2017 – (8.117): Single use systems (SUS) are those technologies used in manufacture of sterile medicinal products which are designed to replace reusable equipment. SUS […]
Compressed Gas Contamination Monitoring in Pharma and Cosmetics Manufacturing: Monitoring Program (Series Part 2 of 2)
The regulatory requirements and best practices for monitoring compressed gasses in the Pharmaceutical and Cosmetics & Personal Care industries are explored.
