PDA Technical Report No. 11, (TR 11) Sterilization of Parenterals by Gamma Radiation (single user digital version)
- Published
- May 1988
- Pages
- 10
- PDA Item Number
- 43216
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- Format
- PDF Single user
- Member Price
- $50.00
- Nonmember Price
- $100.00
- Government Price
- $50.00
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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)
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Table of Contents
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