Regulatory Archives - Particle Measuring Systems https://www.pmeasuring.com/category/regulatory/ Contamination control instruments and expertise Thu, 13 Mar 2025 23:36:28 +0000 en-US hourly 1 https://wordpress.org/?v=6.7.2 https://www.pmeasuring.com/wp-content/uploads/2018/12/cropped-pms-icon-1-150x150.png Regulatory Archives - Particle Measuring Systems https://www.pmeasuring.com/category/regulatory/ 32 32 Cleanroom Standards, Classification and Compliance – Quick-Reference Guide https://www.pmeasuring.com/cleanroom-compliance-free-quick-reference-guide/ Thu, 13 Mar 2025 00:36:39 +0000 https://www.pmeasuring.com/?p=140991 Particle Measuring Systems has created these Cleanroom Standards, Compliance & Classification quick-reference cards. A free quick-reference tool designed to help you navigate cleanroom standards with ease.

The post Cleanroom Standards, Classification and Compliance – Quick-Reference Guide appeared first on Particle Measuring Systems.

]]> Data Analytics in Pharmaceutical Manufacturing https://www.pmeasuring.com/pharmaceutical-manufacturing-data-management-environmental-monitoring/ Mon, 29 Jan 2024 18:22:39 +0000 https://www.pmeasuring.com/?p=138134 What Cleanroom Data Analytics in Pharmaceutical Manufacturing Should be Considered When Setting up Environmental Monitoring? Pharmaceutical Manufacturing Data Analytics and Managment is one of the important steps for effective contamination control In a typical pharmaceutical manufacturing plant, there are several important tasks to ensure the product can be handled without...

The post Data Analytics in Pharmaceutical Manufacturing appeared first on Particle Measuring Systems.

]]> EU GMP Guidelines for Environmental Monitoring: Questions and Answers https://www.pmeasuring.com/eu-gmp-annex-1-faqs-environmental-monitoring/ Tue, 02 Jan 2024 23:50:04 +0000 https://www.pmeasuring.com/?p=137866 Answers to EU GMP Annex 1 FAQs and concerns on the topic of environmental monitoring.

The post EU GMP Guidelines for Environmental Monitoring: Questions and Answers appeared first on Particle Measuring Systems.

]]> EU GMP Annex 1 Airflow Questions and Answers https://www.pmeasuring.com/eu-gmp-annex-1-air-speed-strategies-for-unidirectional-flows-faqs/ Tue, 02 Jan 2024 23:05:40 +0000 https://www.pmeasuring.com/?p=137896 Answers to EU GMP Annex 1 FAQs and concerns on the topic of air speed strategies for unidirectional flows.

The post EU GMP Annex 1 Airflow Questions and Answers appeared first on Particle Measuring Systems.

]]> Cleanroom Occupancy State, Classification & Monitoring: What’s the Difference? https://www.pmeasuring.com/cleanroom-occupancy-state-classification-monitoring-whats-the-difference/ Fri, 08 Dec 2023 16:59:06 +0000 https://www.pmeasuring.com/?p=137445 The complete Annex 1 rewrite raises interest in understanding the nuances of cleanroom operations, particularly in terms of occupancy states, classification, and monitoring. We discuss these intricacies here.

The post Cleanroom Occupancy State, Classification & Monitoring: What’s the Difference? appeared first on Particle Measuring Systems.

]]> Annex 1:2023 and Environmental Monitoring https://www.pmeasuring.com/environmental-monitoring-according-annex-12023/ Wed, 06 Dec 2023 21:26:56 +0000 https://www.pmeasuring.com/?p=137436 This post will explore the technicalities and practical applications of these guidelines, exploring its implications for cleanroom operations and microbial monitoring.

The post Annex 1:2023 and Environmental Monitoring appeared first on Particle Measuring Systems.

]]> USP 797 Updates https://www.pmeasuring.com/usp-797-updates/ Thu, 30 Nov 2023 18:01:38 +0000 https://www.pmeasuring.com/?p=137505 The most recent revision to USP 797 brings forth changes that touch various aspects of pharmaceutical practices. Here, we explore the USP Regulatory Standards Development Process.

The post USP 797 Updates appeared first on Particle Measuring Systems.

]]> Microbiological Air Monitoring: Navigating Choices in Cleanroom Contamination Control https://www.pmeasuring.com/microbiological-air-monitoring/ Mon, 27 Nov 2023 21:54:51 +0000 https://www.pmeasuring.com/?p=137336 This blog post discusses navigating choices in cleanroom viable air monitoring, offering fundamental insights to guide your approach.

The post Microbiological Air Monitoring: Navigating Choices in Cleanroom Contamination Control appeared first on Particle Measuring Systems.

]]> BLOG: USP 1116 Commonly Asked Questions https://www.pmeasuring.com/blog-usp-1116-commonly-asked-questions/ Thu, 01 Sep 2022 11:18:54 +0000 https://www.pmeasuring.com/?p=131972 Welcome to our USP 1116 questions and answers blog, where Particle Measuring Systems answers commonly asked questions pertaining to the USP 1116 guidance. What guidance is there for non-sterile facilities in regards to CRR (aseptic processing)? It is important to note that <1116> is a “general information” chapter, and as such,...

The post BLOG: USP 1116 Commonly Asked Questions appeared first on Particle Measuring Systems.

]]> BLOG: USP 788 vs 1788: How do They Compare? https://www.pmeasuring.com/blog-usp-788-vs-1788-how-do-they-compare/ Thu, 01 Sep 2022 11:14:04 +0000 https://www.pmeasuring.com/?p=131974 Why the USP 1788 update? New flow imaging technologies and therapeutic protein solutions widened the scope of USP 1788. Three primary technologies are discussed in each of the sub-parts of the guidance document: Light Obscuration (LO) is still the preferred first-pass method for the USP Normative chapters. If a solution is...

The post BLOG: USP 788 vs 1788: How do They Compare? appeared first on Particle Measuring Systems.

]]>