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PDA Technical Report No. 11, (TR 11) Sterilization of Parenterals by Gamma Radiation (single user digital version)

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  • Description
  • Table of Contents

Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.

This Technical Report was prepared by the Radiation Sterilization Task Force Members.

It provides general information concerning development and validation of gamma sterilization processes employing cobalt-60 and cesium-137 isotopes as a source of ionizing radiation.

Available to download
Format: PDF (1 file - 1.19 MB)

Click here for the digital downloading instruction and Terms of Usage.

Table of Contents:

Introduction
Radiation Sterilization Facility Considerations
Equipment Qualification
Preliminary Studies
Product Handling
Documentation
Dosimetry Considerations
Product/Container Radiation Compatibility
Stability Considerations
Dose Setting Procedures
Validation
Process Monitoring
Summary
Literature Cited
Bibliography

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