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:
- Sampling methods are evaluated for optimum use and placement at the time of fill line manufacture, to include:
- A fluid dynamics study should be performed to understand turbulences in the area and adjacent areas for accurate placement of sampling points.
- Thoroughly define the pressure cascade from area to area for accurate placement of sampling points.
- 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
- Define potential sampling points for additional coverage based on available space:
- 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)
- Define frequency of sampling
- Define incubation procedure for microbial sampling
- 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
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