Research & Development World

  • Home Page
  • Topics
    • Aerospace
    • Archeology
    • Automotive
    • Biotech
    • Chemistry
    • COVID-19
    • Environment
    • Energy
    • Life Science
    • Material Science
    • R&D Market Pulse
    • R&D Management
    • Physics
  • Technology
    • 3D Printing
    • A.I./Robotics
    • Battery Technology
    • Controlled Environments
      • Cleanrooms
      • Graphene
      • Lasers
      • Regulations/Standards
      • Sensors
    • Imaging
    • Nanotechnology
    • Scientific Computing
      • Big Data
      • HPC/Supercomputing
      • Informatics
      • Security
      • Software
    • Semiconductors
  • 2021 R&D 100 Award Winners
    • R&D 100 Awards
    • 2020 Winners
    • Winner Archive
  • Resources
    • Digital Issues
    • Podcasts
    • Subscribe
  • Global Funding Forecast
  • Webinars

How It Works: Continuous Air Monitoring for Viable Particle Testing

By Particle Measuring Systems | February 17, 2017

Problem: Regulations such as EU GMP Annex 1, FDA Aseptic Filling Guide, and ISO 14698, require the manufacturer to provide frequent or continuous monitoring to take place as close as possible to critical control points without adding any risk to the final product or the test. 1

Current sampling methods, such as passive air sampling, do not have the capability to fulfill all regulatory requirements. They either provide a snapshot of the manufacturing process, or impose a risk to the process through frequent handling interference when performed close to sampling points identified by risk assessment.

Solution: Continuous monitoring is a worldwide-accepted standard for non-viable particle testing, and can now be applied to viable air monitoring with the BioCapt Single-Use from Particle Measuring Systems. With this single use device, monitoring effectiveness is improved while removing most handling interference.

A complete 8-hour manufacturing process is commonly monitored with plates collecting at 100 LPM for a total sample volume of 1 m³ per plate. With this method, only small snapshots of the entire manufacturing process are known. At lower flow rates of 25 or 50 LPM with more frequent and longer monitoring times, it is observable that manufacturers have a better understanding of the total process, but incomplete data. With the BioCapt Single-Use, a 2-hour sampling at 25 LPM allows for the usage of only 4 units to monitor the full process. The statistical relevance of the total sampling is increased, with a sample volume of 12 m³ with 4 devices.

The BioCapt Single-Use viable air monitoring device is a demonstrable solution to the dilemma of continuous monitoring of critical control points without impacting product or test quality. With an increased sampling time of 2 hours and a flow rate of 25 LPM, the device collects 3 m³ of air.

The single use technology allows for minimal manipulation and maximal security of the manufacturing process. Applying the Single-Use in a critical environment can help to improve the quality of the process, reducing overall cost.

For more information about this product, visit www.pmeasuring.com.

Related Articles Read More >

Enclosures isolate robotic and lab automation processes and equipment
Safely contain airborne particulate with CCS (Controlled Containment System)
Modular cleanlabs feature modular construction
EnviroMax on Blue BG
Enclosures for Lab Automation and Robotics
2021 R&D Global Funding Forecast

Need R&D World news in a minute?

We Deliver!
R&D World Enewsletters get you caught up on all the mission critical news you need in research and development. Sign up today.
Enews Signup

R&D World Digital Issues

February 2020 issue

Browse the most current issue of R&D World and back issues in an easy to use high quality format. Clip, share and download with the leading R& magazine today.

Research & Development World
  • Subscribe to R&D World Magazine
  • Enews Sign Up
  • Contact Us
  • About Us
  • Drug Discovery & Development
  • Pharmaceutical Processing
  • 2022 Global Funding Forecast

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search R&D World

  • Home Page
  • Topics
    • Aerospace
    • Archeology
    • Automotive
    • Biotech
    • Chemistry
    • COVID-19
    • Environment
    • Energy
    • Life Science
    • Material Science
    • R&D Market Pulse
    • R&D Management
    • Physics
  • Technology
    • 3D Printing
    • A.I./Robotics
    • Battery Technology
    • Controlled Environments
      • Cleanrooms
      • Graphene
      • Lasers
      • Regulations/Standards
      • Sensors
    • Imaging
    • Nanotechnology
    • Scientific Computing
      • Big Data
      • HPC/Supercomputing
      • Informatics
      • Security
      • Software
    • Semiconductors
  • 2021 R&D 100 Award Winners
    • R&D 100 Awards
    • 2020 Winners
    • Winner Archive
  • Resources
    • Digital Issues
    • Podcasts
    • Subscribe
  • Global Funding Forecast
  • Webinars