• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

+1 303-443-7100

  • Linkedin
  • Twitter
  • English
    • 中文
    • 台灣
    • Singapore
    • Denmark
    • English / CH
    • Français
    • Français / CH
    • Deutsch
    • Deutsch / CH
    • Deutsch / AT
    • Italiano
    • 日本語
    • 한국어
    • Português
    • Español
Newsletter

Search

Particle Measuring Systems
Without measurement there is no control
Request a Quote
  • Home
  • Products
    • Aerosol Particle Counters
    • Liquid Particle Counters
    • Microbial Samplers
      • Certificates of Analysis
    • Compressed Gases Particle Counters
    • Molecular Monitors
    • Software / Data Management
  • Education
    • Knowledge Center
      • Application Notes
      • Beginner Guide to Particle Counting
      • Videos
      • Webinars – Upcoming
      • Webinars – Archived
    • Particle College – Electronics Industry Focused
    • GMP Academy: EM Course
    • Software / Data Management
    • Blog
  • Applications
    • Industries
      • Pharma
      • Semi
      • Photonics & Optics
      • Aerospace
      • Cosmetics & Personal Care
    • ISO 14644
    • ISO 21501-4
    • USP 797
    • USP 788
    • Parts Cleanliness Testing
    • EU GMP Annex 1
    • 21CFR 11
    • Continuous Monitoring
  • Services and Support
    • Product Calibration and Service
    • Hardware & Software Support
    • Customer Service
    • Advisory Service
  • About Us
    • Contact Us
    • Why PMS
    • Executives
    • Careers
    • Corporate Responsibility
    • COBE
    • Parent Company
    • Press Releases
    • Credibility & Registrations
    • Trademarks & Patents
    • Anti-Slavery
    • Export Compliance
Replacing Settle Plates with Active Air Sampling

Replacing Settle Plates with Active Air Sampling

The most universally applied method for cleanroom classification is the one suggested in 1963 by Federal Standard 209 of the USA. In this standard the number of particles equal to and greater than 0.5 µm is measured in one cubic foot of air. This count is then used to classify the room (1 particle = class 1; 10 particles = class 10…). In the same period, scientific publications concerning healthcare facilities suggested that airborne particles carrying micro-organisms associated with human disease were usually found in the 4-20 µm equivalent diameter range. This contamination can be detected by settle plates.

Historically, cGMP guidelines highlighted their expectations concerning a microbiological continuous process monitoring in A and B grades (FDA guideline_2004 and Annex 1_2008) by referring to settle plates because no other technology was easily available. Unfortunately, settle plates is a non-validatable method as it is simply based on the physical principle of the downfall of a particle on a surface. We will discusses the utility of active air versus passive air settle plate monitoring in routine environmental monitoring on the basis of actual scientific knowledge.

  • Speaker

    Paola Lazzeri

    EMEA Sterility Assurance / Microbiology Product Specialist, Particle Measuring Systems

    Paola is currently part of the EMEA Sterility Assurance / Microbiology Product Specialist Team and the Advisory Team in Particle Measuring Systems. She is a subject matter expert in the field of cleaning and sanitization of Pharmaceutical Cleanrooms through constant dialogue with operators, quality officers, and financial and production teams. She has experience in examining and understanding contamination issues with specific focus on microbiological hazard, setting rational cleaning and sanitization of cleanroom and pharmaceutical manufacturing plants with relative drafting of VMP, and supporting pharma companies in the validation of sanitizing and decontaminating agents. Paola participates as a speaker at national and international conferences.

  • Speaker

    Anna Campanella

    Global Sterility Assurance & Advisor, Particle Measuring Systems

    Anna Campanella, PhD, is the Global Sterility Assurance Advisor for Particle Measuring Systems. In this role, she uses her industry experience to collaborate and consult with pharmaceutical companies to develop and implement science-based strategies, principles of monitoring, and controlling and improving the chemical, physical, and microbiological state of various production processes. Anna has a diverse background in the Pharmaceutical field including a PhD in Molecular Medicine, expertise in QA&QC processes, validation of chemical and microbiological methods, validation of sterile production processes and experience in microbiological aspects of aseptic production processes.

Complete this form to access the webinar:

Products

  • Aerosol Particle Counters
  • Liquid Particle Counters
  • Microbial Samplers
  • Certificates of Analysis
  • Compressed Gases Particle Counters
  • Molecular Monitors
  • Software / Data Management

Industries

  • Pharma
  • Semi
  • Photonics & Optics
  • Aerospace
  • Industrial Manufacturing

Service & Support

  • Advisory Service
  • Product Calibration and Service
  • Customer Service

Knowledge Center

  • Application Notes
  • Particle College – Electronics Industry Focused
  • Videos
  • Webinars
  • Blog

About Us

  • Contact Us
  • Why PMS
  • Executives
  • Careers
  • Corporate Responsibility
  • COBE
  • Parent Company
  • Press Releases
  • Credibility & Registrations
  • Trademarks & Patents
  • Anti-Slavery
  • Export Compliance

Particle Measuring Systems

Corporate Headquarters
5475 Airport Blvd.
Boulder, CO 80301

T. +1 303-443-7100
F. +1 303-440-1090
E. [email protected]

Keep in touch! Receive industry news from us:

Products

  • Aerosol Particle Counters
  • Liquid Particle Counters
  • Microbial Samplers
  • Certificates of Analysis
  • Compressed Gases Particle Counters
  • Molecular Monitors
  • Software / Data Management

Industries

  • Pharma
  • Semi
  • Photonics & Optics
  • Aerospace
  • Industrial Manufacturing

Applications

  • ISO 14644
  • ISO 21501-4
  • USP 797
  • USP 788
  • Parts Cleanliness Testing
  • EU GMP Annex 1
  • 21CFR 11

Service & Support

  • Advisory Service
  • Product Calibration and Service
  • Customer Service

Education and Training

  • Knowledge Center
  • Particle College – Electronics Industry Focused
  • Software / Data Management
  • Blog

About Us

  • Contact Us
  • Why PMS
  • Executives
  • Careers
  • Corporate Responsibility
  • COBE
  • Parent Company
  • Press Releases
  • Credibility & Registrations
  • Trademarks & Patents
  • Anti-Slavery
  • Export Compliance

Particle Measuring Systems

Corporate Headquarters
5475 Airport Blvd.
Boulder, CO 80301

T. +1 303-443-7100
F. +1 303-440-1090
E. [email protected]

Keep in touch! Receive industry news from us:

  • Website Disclaimer
  • Third Party Privacy Notice
  • Privacy Policy
  • Legal

© Copyright 2020 - Particle Measuring Systems is a Spectris company