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Connecting People, Science and Regulation ®. Steam Sterilization and the Revision of PDA Technical Report 1. Presented By: Mike Finger (Tunnell Consulting). Don Drew (Abbott Bioresearch Center). 14 November PDA Technical Report No. 1, Revised , (TR 1) Validation of Moist Heat. Sterilization Processes Cycle Design, Development, Qualification and. Ongoing Control – • ISO Sterilization of healthcare products-Moist • ISO Sterilization of health care products – Requirements for. PDA Technical Series: Sterilization. Compilation of Technical Reports and Journal. Articles on Pharmaceutical Sterilization. Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control. Technical Report No. 1. Validation of Dry Heat Processes Used for Depyrogenation.
PDA Technical Report Overview. Ensuring product safety. TR No. Title. Publication. 1. Validation of Moist Heat Sterilization Processes: Cycle Design, Development,. Qualification and Ongoing Control. Revised (published ). 3. Validation of Dry Heat Processes Used for Depyrogenation and Sterilization. EN ISO □ PDA Technical Report No. 1. □ Other relevant standards and guidance. □ The world approach. Part IV: Validation principles. Background information that relates specifically to the validation of steam sterilization. Delegates will be able to establish the key aspects necessary for the ef-. Steam Sterilization and the Revision of PDA Technical Report 1. 14 November Presented By: Mike Finger (Tunnell Consulting) Don Drew ( Abbott Bioresearch Center). Connecting People, Science and Regulation ®. Agenda: • Introduction • Sterilization Science • Sterilization Process Development • Process.
GAMP. • The Good Automated Manufacturing Practice (GAMP) Guide for. Validation of Automated Systems in Pharmaceutical Manufacture,. Vol. 4. • PDA Technical Reports. • PDA Technical Report No. 1, Validation of Steam Sterilisation Cycles. • HTM (Health Technical Memorandum). • ; Sterilisation; Part 3: Validation. PDA Technical Monograph 1 – Validation of Steam Sterilisation. Cycles ▫ PDA Technical Report 3, (TR3) Validation of Dry Heat Processes. Used for Sterilization and Depyrogenation (under revision). ▫ USP Biological Indicators. ▫ USP Sterilisation and Sterility Assurance of Compendial. Articles. Assess appropriate loading configuration for uniform temperature distribution and heat penetration. ▫ Determine time parameters for the various parameters monitored. ▫ Sterilization occurs at a variety of time and temperature parameters, and in the USA many different combinations are used. ▫ See PDA Technical Report 1.