PDA has revised Technical Report No. 3, originally issued in 1981. The revision offers a modern, scientific approach to dry-heat depyrogenation and sterilization processes and includes recommendations for use by industry and regulators. References to appropriate and current scientific publications, international regulatory documents, journal articles, technical papers and books are used where more detail and supportive data can be found.
This technical report provides information to the manufacturers of pharmaceutical products for validating dry-heat depyrogenation and sterilization processes. The concepts and methods presented within this technical report are not intended to be a regulatory standard, but rather as points to be considered during the validation of dry-heat processes. Other technically equivalent methods may exist and may be used if they can be supported by sound scientific methods.
The technical report task force is composed of diverse international team of professionals to ensure the methods, terminology and practices of dry-heat depyrogenation and sterilization processes reflect sound science and can be used globally. This technical report was disseminated in draft for public review and comment prior to publication to ensure its suitability as a recommendation of best practices to industry.
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Table of Contents:
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Figures and Tables Index
- Glossary of Terms
- The Science of Dry Heat Depyrogenation and
- Equipment Design
- Equipment Qualification
- Process Development
- Performance Qualification
- Ongoing Process Control