№ lp_1_13661
Internal controls document defining organizational, technical, and procedural requirements for operating a dosimetry laboratory used in radiation processing to measure, control, and record absorbed dose in compliance with recognized international and regulatory standards.
Document type: Operating procedure
Subject area: Radiation processing dosimetry
Applicable standards: ISO/ASTM 52628; ISO 11137; FDA 21 CFR Part 11; EU Annex 11; FDA cGMP
Dosimetry system: GEX B3 radiochromic film dosimetry system
System supplier: GEX Corporation
Laboratory ownership: Quality department
Scope: Dosimetry laboratory operations supporting a specified irradiation process
Equipment: Spectrophotometer; reference standards; film dosimeters; incubators; software; accessories
Measurement method: Optical absorbance measurement traceable to national standards
Dosimeter types: Routine dosimeter; transfer-standard dosimeter
Operational controls: Calibration; environmental monitoring; maintenance; procurement; shipment; receipt
Applicable process: Irradiation process specified by end user
Price: 8 / 10 USD
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