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

+65 6496 0330

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

Search

  • Linkedin
  • Twitter
Particle Measuring Systems
Without measurement there is no control
Get a Quote
  • Home
  • Products
    • Aerosol Particle Counters
    • Liquid Particle Counters
    • Microbial Samplers
      • BioCapt®Certificates of Analysis
    • Compressed Gases Particle Counters
    • Molecular Monitors
    • Environmental Monitoring Systems
  • Education
    • Knowledge Center
      • Application Notes
      • Videos
      • Webinars – Archived
    • Particle College
    • Software / Data Management
    • Blog
  • APPLICATIONS
    • INDUSTRIES
      • PHARMACEUTICAL
      • SEMICONDUCTOR
      • PHOTONICS&OPTICS
      • AEROSPACE
      • Cosmetics & Personal Care
    • Annex 1
    • ISO 14644
    • 21 CFR 11
    • ISO 21501-4
    • USP 788
    • USP 797
    • PARTS CLEANLINESS TESTING
  • Service and Support
    • Advisory Service
    • Product Calibration and Service
    • Customer Service
  • About Us
    • Contact Us
    • Why PMS
    • Particle Measuring Systems’ Executive Team
    • Particle Measuring Systems’ Careers
    • Corporate Responsibility
    • COBE
    • Parent Company
    • Press Releases
    • Credibility & Registrations
    • Trademarks & Patents
News Blog
September 29, 2020 12:30 PM

Powder Filling: Sample Points and Risk Analysis

Written by PMS

Read the previous blog in this series here.

sample-probe

Where Do I Monitor for Contamination?

The next concern after validating your monitoring process for powder filling is: Where should I sample? As previously discussed, the EU GMP Annex 1 states the monitoring should be routine and based on risk analysis. Particle Measuring Systems uses an approach that is based on extensive process flow and environmental monitoring experience. Regulatory guidance supports this approach and along with an issued system rationale document. It uses data attained during a room classification exercise to justify selection parameters.

Cleanroom classification essentially proves that the room meets its specification for both cleanliness and uniformity. Much of the ISO 14644-1 standard supports the following:

  • The cleanroom meets a particle count concentration requirement.
  • The room’s concentration is evenly distributed.

If a cleanroom is not uniform and has areas considered worse-off than others, the room will not meet uniformity requirements. In addition, it won’t comply with the 96% upper control limit (UCL). There are steps to make a room uniform and Particle Measuring Systems experts can offer guidance for your specific circumstances.

Who Can Perform a Risk Analysis?

Suitable locations for the sample within the RABS or background area can be determined by applying a grid similar to the grid in the Particle Measuring Systems application note Choosing the Most Suitable Particle Sample Point Locations. The shape of the grid is based on the process to be qualified. Quality assurance teams may work together with third-party experts to optimize their sampling. Contact the Particle Measuring Systems Advisory Team for a personalized risk analysis and EM support for your facility.

 

Interested in the full paper? Click here to download for free.

Filed Under: Cleanroom Classification Qualification, Cleanroom Monitoring, Particle Knowledge

Archives

  • January 2021 (1)
  • December 2020 (2)
  • November 2020 (5)
  • September 2020 (4)
  • August 2020 (1)
  • July 2020 (3)
  • June 2020 (3)
  • May 2020 (6)
  • April 2020 (11)
  • March 2020 (2)
  • February 2020 (4)
  • January 2020 (1)
  • December 2019 (2)
  • November 2019 (3)
  • May 2016 (1)
  • March 2016 (1)
  • February 2016 (3)

Subscribe to our news feed!

Products

  • Aerosol Particle Counters
  • Liquid Particle Counters
  • Microbial Samplers
  • BioCapt®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
  • Videos
  • Blog

About Us

  • Contact Us
  • Why PMS
  • Particle Measuring Systems’ Executive Team
  • Particle Measuring Systems’ Careers
  • Corporate Responsibility
  • COBE
  • Parent Company
  • Press Releases
  • Credibility & Registrations
  • Trademarks & Patents

Particle Measuring Systems- USA

Corporate Headquarters
5475 Airport Blvd
Boulder, CO 80301

T. +1-303-443-7100
T. +1-800-238-1801
F. +1-303-449-6870
E. [email protected]

Keep in touch! Receive industry news from us:

Products

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

Industries

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

Applications

  • ISO 21501-4
  • Parts Cleanliness Testing

Service & Support

  • Advisory Service
  • Product Calibration and Service
  • Customer Service

Education and Training

  • Knowledge Center
  • Particle College
  • Software / Data Management
  • Blog

About Us

  • Contact Us
  • Why PMS
  • Particle Measuring Systems’ Executive Team
  • Particle Measuring Systems’ Careers
  • Corporate Responsibility
  • COBE
  • Parent Company
  • Press Releases
  • Credibility & Registrations
  • Trademarks & Patents

Particle Measuring Systems- SG

Corporate Headquarters
5475 Airport Blvd
Boulder, CO 80301

T. +1-303-443-7100
T. +1-800-238-1801
F. +1-303-449-6870
E. [email protected]

Keep in touch! Receive industry news from us:

  • Privacy Policy
  • Legal

© Copyright 2021 - Particle Measuring Systems is a Spectris company