Particle monitoring requirements in pharmaceutical cleanrooms

Published: 1-Oct-2010
Design & Build Analysis

GMP regulations require that these environments are rigorously monitored to ensure that there is full and constant awareness of current environmental conditions, both for viable and non-viable contamination


Why do I need a Particle Counter?

This is a frequently asked question from current or potential pharmaceutical cleanroom personnel. The legislation and cGMP guidelines clearly state why microbiological monitoring must be performed and impose limitations for production environments. Little mention is made of routinely monitoring the particle count levels. So what value does it add and why should I be doing it?

  • Companies:
  • PMT GB
See more

You may also like

Cleaning

MicronView and PMT join forces to grow environmental monitoring instrument reach

Read more
Texas-based environmental monitoring instrument manufacturer MicronView has partnered with the European distribution company

Trending Articles

  1. You need to be a subscriber to read this article.
    Click here to find out more.
    What is ISO 8 cleanroom classification? Each cleanroom class is denoted by a maximum concentration of particles per cubic meter or cubic foot of air. ISO 8 is the second lowest cleanroom classification
  2. You need to be a subscriber to read this article.
    Click here to find out more.
    Integrity testing of HEPA filters: A practical approach Filtering the air in aseptic process areas is critical to maintaining the cleanliness of the production environment. Jesus Casas provides tips to ensure HEPA filters are fit for purpose once installed in your facility
  3. Germfree mobile cleanroom finishes pilot programme for hospital lidocaine production Modular cleanroom expert Germfree and pharma expert ODP are now working to expand a pilot programme after a successful six months of producing medications at North Mississippi Medical Center
  4. Airkey delivers ISO 6 modular cleanroom for manufacturing of microelectronic devices As sanctions on chip export to China grow more and more intense, a growing number of companies in China develop and produce chips and related microelectronic parts on their own.
  5. Microbiological monitoring: Adapting to new rapid methods regulatory demands Dr Wan Li Low from Cherwell takes a look at the shift towards Rapid Microbiology Methods (RMM) and their validation

Upcoming event

EMPQ Essentials and Real-World Strategies for Successful Cleanroom Qualifications

16 January 2025 | Virtual See all

You may also like

Cleaning

MicronView and PMT join forces to grow environmental monitoring instrument reach

Texas-based environmental monitoring instrument manufacturer MicronView has partnered with the European distribution company
Analysis

New active air sampler on the market is Annex 1-ready

The equipment has been designed to meet the latest standards for continuous viable monitoring
Analysis

Compact FMSnode integrates cleanroom sensors

It has an open software structure and modular design
Design & Build

Counting airborne bacteria in real time

Measuring system does away with the need for costly sample preparation
Design & Build

Selecting an airborne-particle counter for your environment

Understanding which features you need in a particle counter is a difficult task. This article will identify the various features available and help you choose which are relevant to your application
Design & Build

Particle monitoring in high-pressure gas lines

In today’s high-tech manufacturing processes, there are a diverse number of procedures demanding minimal levels of particle contamination. With continuous monitoring improvements, the minimum thresholds are always being challenged for an environment to become “more clean”.
Design & Build

GMP particle sensor – data security guaranteed

Integrated data logger backs up eight hours of particle data
Subscribe now