Workshop on PDA Technical Report No. 1, Revised 2007, Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control
December 3-4, 2008 | Bethesda, Maryland
Join members of the PDA Task Force on PDA Technical Report No. 1 and industry representatives at the workshop on PDA Technical Report No. 1, 2007 Revision – Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control to discuss the recommendations in the 2007 revision. The product of new contributions and original text revisions by 40 contributors with scientific and regulatory backgrounds, the 2007 revision of PDA Technical Report No. 1 contains consensus scientific guidance and recommendations on how to establish a moist heat sterilization program that may be applied globally.
PDA’s original Technical Monograph No. 1, Validation of Steam Sterilization Cycles, first published in 1978, introduced the principles of steam sterilization to an entire generation of pharmaceutical scientists and engineers. This revision retains the focus on the general approach to sterilization science contained in the original document, while updating it to include contemporary subject matter on the microbiology, thermal science and engineering of moist heat sterilization. PDA Technical Report No. 1 presents recommendations for best practices in a logical progression from the essential elements of sterilization science and technology through sterilization cycle design, development and ongoing control.
Please bring your copy of the revised PDA Technical Report No. 1 with you to the workshop. The report may also be purchased onsite for $75 (PDA members) or $120 (non-members).
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