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Dose Mapping Validation Maintenance |
Dose Mapping
Process Qualification (Dose Mapping)
Definition - Process qualification entails dose mapping a particular product and/or group of products. Dose mapping is the determination of the loading configuration which will be used during routine sterilization.
Procedure - In dose mapping, dosimeters are placed throughout products at strategic locations to determine the zones of minimum and maximum dose. Three test repetitions need to be performed during dose mapping in order to establish statistical reliability. Dose mapping yields the following results:
A max to min ratio which is the ratio of the maximum dose to minimum dose contained within the product
The establishment of a carrier loading pattern to be used during routine processing
Establishment of the mathematical correlation between the dose at the Standard Monitoring Position and doses within the actual product boxes.