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PDA TR 01-2007

Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control

PDA’s original Technical Monograph No. 1, Validation of Steam Sterilization Cycles, published in 1978, introduced the principles of steam sterilization to an entire generation of pharmaceutical scientists and engineers. The revision retains a focus on the microbiology and engineering of moist heat sterilization and the general approach to sterilization science embodied in the original document, and updates it by including contemporary subject matter.


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Parenteral Drug Association [pda]


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