PDA TR 3

Technical Report No. 3, Revised 2013 (TR 3) Validation of Dry Heat Processes Used for Depyrogenation and Sterilization

Parenteral Drug Association , 07/01/2013

Publisher: PDA

File Format: PDF

$162.00$325.00


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.

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