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

+39 06 9053 0130

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

Search

  • Linkedin
  • Twitter
Particle Measuring Systems
Without measurement there is no control
Richiedi un preventivo
  • Home
  • Prodotti
    • Contatori di Particelle per Aria
    • Contatori di Particelle per Liquidi
    • Campionatori Microbiologici
      • BioCapt®Certificates of Analysis
    • Monitoraggio della Contaminazione nei Gas Compressi
    • Monitoraggio Molecolare
    • Software / Data Management
  • Formazione
    • Virtual Particle Days 2020
    • Knowledge Center
      • Application Notes
      • Guida Base al Conteggio Particellare
      • Video
      • Webinar – Archivio
    • Servizi di Training e Consulenza
    • Blog
  • Applicazioni
    • Industrie
      • Life Sciences/Farmaceutico
      • Semiconduttori
      • Fotonica e Ottica
      • Aerospaziale e Difesa
      • ISO 22716 Soluzioni per la Cosmetica e l’Igiene Personale
    • ISO 14644
    • ISO 21501-4
    • USP 788
    • USP 797
    • Annex 1 Ultimi Aggiornamenti
    • 21CFR 11
  • Servizi e Supporto
    • Servizi di Project Management del Sistema di Monitoraggio
    • Servizi di GMP
      • Misurazione
      • Smoke Test
      • Convalide Termiche
    • Servizio Calibrazione e Riparazione
    • Servizio Clienti
    • Servizi di Advisory
  • Chi siamo
    • Contattaci
    • Perché PMS
    • Management
    • Lavora con noi
    • Responsabilità Aziendale
    • COBE
    • Casa Madre
    • Comunicati Stampa
    • Qualità e Riconoscimenti
    • Marchi e Brevetti
Blog
Aprile 29, 2020 07:22 AM

Achieve Quality by Design (QbD) in a New Pharmaceutical Fill Line: Environmental Monitoring (Series Part 5 of 6)

Written by Maurizio Della Pietra

Quality by Design (QbD) for a filling line

An Environmental Monitoring (EM) plan for a new isolator/RABS will provide the assurance via routine monitoring that the planning you did to control contamination from the incoming materials, process and operators is working. For EM to work optimally, ideal sample point placement for particle counters and microbial monitors  is necessary. The best way to ensure that your strategy is effectively put into action is to implement it into the design phase of the fill machine using Quality by Design (QbD) principles.

Below are the various elements of a robust EM strategy for your aseptic filling operations. It will help to keep your process in control, and alert you before it goes out of control, even in the most unexpected of circumstances.

Environmental Monitoring considerations for fill lines designed without Quality by Design (QbD):

Problems associated with the retro-positioning of monitoring points not related to the process include, but are not limited to:

  • Particle counter sampling heights may not be properly defined if not established early in the process.
  • Sampling points may not have been installed in accordance with regulatory requirements. An evaluation of the original installation is required to ensure they are in compliance.
  • There is frequently a high financial cost to moving the points after installation. This is a very undesirable and unnecessary cost.

Considerations made to incorporate Environmental Monitoring into fill lines with a PMS QbD solution:

  1. Sampling methods are evaluated for optimum use and placement at the time of fill line manufacture, to include:
    •  Traditional placement of periodic monitoring for particle counters and microbial monitors
    • Remote, real-time monitoring
    • A combination of both
  2. A fluid dynamics study should be performed to understand turbulences in the area and adjacent areas for accurate placement of sampling points.
  3. Thoroughly define the pressure cascade from area to area for accurate placement of sampling points.
  4. Perform a process study for each section of the fill equipment to determine accurate (and possibly unexpected) placement of sampling points.
    • On the work surfaces
    • In the technical area below the isolator
  5. Define potential sampling points for additional coverage based on available space:
  6. Define the position of critical sampling points based on:
    • Production activities and necessary interventions
    • Materials flow: incoming and outgoing
    • Exposure of product and critical materials and equipment
    • Positioning of gloves
    • Air turbulence
    • Type of materials (for surfaces only)
  7. Define frequency of sampling
  8. Define incubation procedure for microbial sampling
  9. Establish the scope and critical factors for the correct installation of a monitoring system

In the next blog in this series we will examine the timing, management and administrative activities to implement QbD on a new fill line at the design phase. These examples come from real-world applications experienced by the Particle Measuring Systems’ Advisory Services Team. Our team has over 70 years of collective experience working in and advising cleanroom users around the world.

Learn more about how our Contamination Control Advisory Services Team can help you identify problems and suggest solutions to preserve the high quality of your products and processes.

See links to additional supporting resources below: 

  • On-Demand Webinar: Developing an Isolator Filling Line Using a Quality Risk Management Approach
  • Corresponding Application Note: Developing an Isolator Filling Line Using a QRM Approach – FAQ’s
  • Blog: It is possible for pharmaceutical quality to be the combination of Quality by Design (QbD) and current Good Manufacturing Practices (cGMP)?
  • Blog: Applying Quality Risk Management to Develop an Isolator Filling Line

Want to read more? Jump to other released posts in this series:

  • Part 1 of 6:  Intro and Regulatory
  • Part 2 of 6:  Surrounding Areas
  • Part 3 of 6:  Cleaning and Disinfection 
  • Part 4 of 6:  Set up and Process Interventions
  • Part 5 of 6:  Environmental Monitoring (You are here!)
  • Part 6 of 6:  Activity Organization

Don’t miss an episode of this series. Register for updates on the right column of this page. Click here to contact our Experts for questions.

Filed Under: Particle Knowledge Tagged With: active air sampling, contamination control, contamination monitoring, environmental monitoring, particle counting, Qbd

Archives

  • Agosto 2020 (1)
  • Luglio 2020 (3)
  • Giugno 2020 (2)
  • Maggio 2020 (4)
  • Aprile 2020 (7)
  • Marzo 2020 (1)
  • Novembre 2019 (1)
  • Settembre 2019 (1)
  • Giugno 2019 (1)
  • Maggio 2019 (1)
  • Febbraio 2019 (1)
  • Ottobre 2018 (1)
  • Ottobre 2017 (1)
  • Marzo 2016 (2)

Iscriviti alla nostra newsletter

Prodotti

  • Contatori di Particelle per Aria
  • Contatori di Particelle per Liquidi
  • Campionatori Microbiologici
  • BioCapt®Certificates of Analysis
  • Contatori di Particelle per Gas Compressi
  • Monitoraggio Molecolare
  • Software / Data Management

Industrie

  • Life Sciences/Farmaceutico
  • Semiconduttori
  • Fotonica e Ottica
  • Aerospaziale e Difesa
  • Produzione Industriale

Servizi e Supporto

  • Servizi di Advisory
  • Servizi di Misurazione GMP
  • Servizio Calibrazione e Riparazione
  • Smoke Test GMP
  • Servizi di Convalide Termiche GMP
  • Servizio Clienti

Knowledge Center

  • Application Notes
  • Video
  • Blog

CHI SIAMO

  • Contattaci
  • Perché PMS
  • Management
  • Lavora con noi
  • Responsabilità Aziendale
  • COBE
  • Casa Madre
  • Comunicati Stampa
  • Qualità e Riconoscimenti
  • Marchi e Brevetti

Particle Measuring Systems- IT

Particle Measuring Systems Srl
Via di Grotte Portella, 34
00044 Frascati (Roma)

T. +39-06-90530130
F. +39-06-9051315
[email protected]
P.I. 10427421002

Ricevi i nostri aggiornamenti:

Prodotti

  • Contatori di Particelle per Aria
  • Contatori di Particelle per Liquidi
  • Campionatori Microbiologici
  • BioCapt®Certificates of Analysis
  • Contatori di Particelle per Gas Compressi
  • Monitoraggio Molecolare
  • Software / Data Management

Industrie

  • Life Sciences/Farmaceutico
  • Semiconduttori
  • Fotonica e Ottica
  • Aerospaziale e Difesa
  • Produzione Industriale

Applicazioni

  • ISO 14644
  • ISO 21501-4
  • USP 797
  • Annex 1 Ultimi Aggiornamenti
  • 21CFR 11

Servizi e Supporto

  • Servizi di Advisory
  • Servizi di Misurazione GMP
  • Servizio Calibrazione e Riparazione
  • Smoke Test GMP
  • Servizi di Convalide Termiche GMP
  • Servizio Clienti

Formazione

  • Knowledge Center
    • Particle Days 2019
  • Servizi di Training e Consulenza
  • Blog

CHI SIAMO

  • Contattaci
  • Perché PMS
  • Management
  • Lavora con noi
  • Responsabilità Aziendale
  • COBE
  • Casa Madre
  • Comunicati Stampa
  • Qualità e Riconoscimenti
  • Marchi e Brevetti

Particle Measuring Systems- IT

Particle Measuring Systems Srl
Via di Grotte Portella, 34
00044 Frascati (Roma)

T. +39-06-90530130
F. +39-06-9051315
[email protected]
P.I. 10427421002

Ricevi i nostri aggiornamenti:

  • Privacy Policy
  • Note Legali
  • Marchi e brevetti
  • Accreditamenti e riconoscimenti

© Copyright 2021 - Particle Measuring Systems is a Spectris company