Join members of the PDA Task Force on Technical Report No. 1 and industry representatives at the 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 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. 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.

All attendees will receive a copy of the revised PDA Technical Report No. 1.

Departments
Manufacturing | Formulation | Compliance | Engineering | QA/QC | Development | Regulatory Affairs | Packaging | Research and Development | Technical Operations | Validation | Supply Chain Management

Level of Expertise
Senior Management | Senior Scientists | Project/Program Leader | Technical Contributor

Job Function
Materials scientists | Packaging engineers | Analytical chemists | Toxicologists | Formulators | Product and Process engineers | Regulatory | Biotechnology | Development | Procurement

At the end of this meeting, participants will be able to:

• Explain the applied science and technology underlying moist heat sterilization
• Methodically evaluate an existing moist heat sterilization program
• Select the most appropriate moist heat sterilization process for your specific application
• Develop a new moist heat sterilization program
• Assure adequate cycle control and change documentation
• Explain the principles of physical and biological process performance qualification
• Establish a moist heat sterilization policy which addresses all major elements