news

Novel design proposed for aseptic processing areas

1
SHARES

The approach offers key benefits such as facilitating a reduction in the risk of microbial contamination and reduction in the required air change rate in aseptic processing.

aseptic processing manufacturing

A novel design approach could improve aseptic processing for cell therapy manufacturing, research suggests.

 

ACCESS your FREE COPY

 


This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.

Access the full report now to discover the techniques, tools and innovations that are transforming pharmaceutical formulation, and learn how to position your organisation for long-term success.

What you’ll discover:

  • Key trends shaping the pharmaceutical formulation sector
  • Innovations leading progress in pharmaceutical formulation and how senior professionals can harness their benefits
  • Considerations and best practices when utilising QbD during formulation of oral solid dosage forms
  • And more!

Don’t miss your chance to access this exclusive report ! Access now – it’s free

In their Regenerative Therapy paper, Furomitsu et al. proposed an environment by designing an air mass balance in an aseptic processing area.

The approach used open and closed system equipment consisting of critical processing zones, such as biosafety cabinets and isolator systems.

Separate research published in a paper last year on particle monitoring in biosafety cabinets, demonstrated that “the number of particles and falling bacteria varied depending on the type of clothing.” For example, the authors suggested that the data could be used to identify risks in aseptic manufacturing areas.

In the present research, the proposed space consisted of three zones: critical processing zone and a support zone, the latter being divided into two upper and lower vertical zones, the researchers explained. The support zone was based on airflow and location of the particle emission sources.

The team developed a kinetic model for particle concentration to describe the impact of airflow rate on the cleanliness of the aseptic processing area.

Potential of the design approach for aseptic processing

designing an environment divided regionally can realise cell manufacturing in an [aseptic processing area]”

Based on the findings of their study, the authors stated that the “appropriate location of the air inlet and outlet can construct the cleanliness of the aseptic processing area, which reduces the risk of microbial contamination”.

Furomitsu et al. concluded that “designing an environment divided regionally can realise cell manufacturing in an [aseptic processing area], which eliminates the need for an air duct connected to the equipment from outside the cleanroom, reduces the air change rate, and allows for a more simplified gowning of operators”.

Importance of aseptic connections in manufacturing

As the industry transitions to “more precise processing for biologics or advanced therapy medicinal products (ATMPs) manual aseptic connections will become more crucial in meeting critical process parameters for microbiological quality,” according to Vanessa Vasadi Figueroa.

Share via
Share via