ASEPTIC PROCESSING: TWO - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 256

Personnel
(Risk component A)

Interventions
(Risk component B)

Personnel bioburden levels

Frequency intervention

Personnel bioburden levels

Frequency personnel
bioburden hits

Duration of intervention

Proximity to product

D uration personnel within
critical zone

Frequency of bioburden hits

Transfer coefficient Transfer coefficient

Overall risk

Duration of set up of filling Bioburden levels Transfer coefficient

Bioburden levels Duration of use or filling Bioburden levels

Frequency of bioburden hits Frequency of bioburden hits Duration of facility use or filling

Transfer coefficient Transfer coefficient

Critical
area/equipment
(Risk component C)

Facility
(Risk component D)

Air
(Risk component E)

Figure 10.5 Risk components and their constituent risk factors describing the risk of bioburden ingress during the eleven steps of an aseptic
parenteral filling process [19].

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