Sterile Load Preparation - Release Procedure | ISO 13485 | FDA QSR Compliant
The ISO 13485 Sterile Load Preparation and Release Procedure provides instruction preparing sterile loads, inspection of loads pre and post sterilization, and the requirements to release sterile loads for commercial distribution.
- ISO 13485:2016 Compliant
- CFR 801.150 Compliant
- FDA QSR Compliant
- MS Word Format
- Digital Content - Instant Download
ISO 13485 Sterile Load Preparation and Release ProcedureThe Sterile Load Preparation and Release Procedure governs the preparation and organization of a sterile load, the inspection of post-sterilized product, and the final release of a sterile load for commercial distribution.
Sterile Load Preparation and Release Procedure OverviewThe Sterile Load Preparation and Release Procedure includes everything you need to organize, process and accept sterile loads within your facility for multiple sterilization methods (e.g. EO, Gamma).
The procedure includes: sterile load data forms to properly organize a sterile load; sterile load labeling for each stage of the process to ensure load control; and includes the sterilization records (post sterilization) required for the final release of a sterile load to finished goods.
Sterile Load Preparation and Release Procedure ComplianceThe Sterile Load Preparation and Release Procedure is ISO 13485:2016 and FDA QSR Compliant.
To learn more about our Sterile Load Preparation and Release Procedure contact us at [email protected]
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Sterile Load Preparation and Final Release
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