Risk Prevention in Syringe Filling Line in a Pharmaceutical Manufacturing Plant
Zusammenfassung
Risk prevention in syringe filling line
can be achieved through the implementation of
“Defense in Depth” concepts. Defense in Depth is
based on the integration of 3-layers of operational
controls which are Equipment, Procedure, and
Well-Trained Staff. This project will be conducted
through all stages of a syringe filling process area
in a pharmaceutical company. The objective of this
project is to mitigate critical errors and threat to
operations through the establishment of the
Defense in Depth and thus avoiding costly errors.
This project has three main contributions which
include evaluating the current state of control of
Critical Process Parameters, providing an
assessment of the current operational states, and
lastly setting the expectation that all future
modification to equipment, procedures or staff
qualification should consult the methodology to
ensure continuous improvement. Through Defense
in Depth, this company was able to identify and
strengthen vulnerable and high risk areas in a
syringe filling line.
Key Terms - CAP Analysis, Defense in
Depth, FMEA, Risk Assessment.