Applying QRM to Develop an Isolator Filling Line

<span>Using their knowledge of Quality by Design (QbD) and risk management strategies, Daniele Pandolfi, Global Aerosol Product Line Manager and Maurizio Della Pietra, Global Data Management Specialist and Process Advisor from Particle Measuring Systems answer questions from their recent webinar, &quot;Developing an Isolator Filling Line Using a Quality Risk...</span>

Using their knowledge of Quality by Design (QbD) and risk management strategies, Daniele Pandolfi, Global Aerosol Product Line Manager and Maurizio Della Pietra, Global Data Management Specialist and Process Advisor from Particle Measuring Systems answer questions from their recent webinar, "Developing an Isolator Filling Line Using a Quality Risk Management Approach".

  1. How is the monitoring and classification sampling point defined?
    • The classification and monitoring sampling point are defined by two standards: ISO 14644-1 and ISO 14644-2.
    • ISO 14644-1 requires the definition of the classification sampling point to be based on a table of values created using hypergeometric distribution.
    • For monitoring, ISO 14644-2 requires a formal evaluation of a risk document to identify all areas/locations which may represent risk for the product and environment cleanliness, and therefore require constant control.
  2. Why is the location B1 (isolator is module B) not considered a Critical Control Point?
    • The location B1 of this project is not considered critical because:
      • Bags are gamma irradiated and are introduced in the isolator in secondary packaging.
      • This packaging is decontaminated in the previous module A and transferred/stored in the B1 area still inside the packaging to prevent any potential contamination.
  3. Can I have more information about the FMEA and HACCP methodology?
    • There are several guidelines you can read to better understand the different risk assessment methodology. Most important is ICH Q9, the FDA Guideline, and PIC/S guidelines about risk assessment
  4. Question to IBI: This new “Espresso” drug delivery system is an interesting product. Is it exclusive to your company or can it be purchased?
    • Subsequent to submission/approval we are open to offer this innovation to anyone who is interested.
  5. How was the VHP (H2O2) cycle designed? Did you just evaluate the microbial log reduction?
    • To validate the hydrogen peroxide cycle, a minimum of 3log contamination reduction must be demonstrated.
    • However, while developing a similar nonstandard application, is it extremely important to also evaluate the coverage of VHP fumigation among the whole isolator area.
  6. Do you have a recommended method to evaluate the coverage of VHP?
    • For example, in an early development stage we used coloured media, then tested with chemical indicators before finalizing our validation with bio indicators.
Source: www.pmeasuring.com