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 ;nal product or the test.
Current sampling methods, such as passive air
sampling, do not have the capability to ful;ll 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 identi;ed 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 e;ectiveness 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 ;ow
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 ;ow 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
How It Works: Continuous Air Monitoring for Non-Viable Particle Testing