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PAPER ID: 21012
Quality Risk Assessment of Light Scattering Air Particle Counter Calibration Process According to ISO 21501-4 as Fulfillment of ISO 14644-1’s Clean Room Environmental Monitoring Process
Main Article Content
Abstract
One of the environmental monitoring programs in clean rooms classified according to EN ISO 14644-1 in the pharmaceutical industry is monitoring of nonviable particles, where the monitored particle sizes are ≥ 0.5 µm and ≥ 5.0 µm. Monitoring of non-viable particles in the clean room is carried out using a Light Scattering Air Particle Counter (LSAPC) which calibrated according to EN ISO 21501-4, using Pulse Height Analyzer (PHA) method. However, the old type of LSAPC, which has not adapted the PHA method in its calibration program, is still being used by the pharmaceutical industry in Indonesia. In this study, a quality risk assessment analysis of the use of the old type LSAPC in environmental monitoring in clean rooms using the Failure Mode Effect Analysis (FMEA) method was conducted, by determining the Risk Priority Number (RPN) and proposing solutions as existing risk controls. Mitigation actions taken as risk control are tightening preventive maintenance actions on all old type LSAPCs, using old type LSAPCs for environmental monitoring in lower room cleanliness classes and creating special trending for clean rooms which environmental monitoring uses old type LSAPCs.
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