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The Parenteral Drug Association’s Technical Report No. 26 (TR 26), "Sterilizing Filtration of Liquids," is a comprehensive guide for filter validation and integrity testing in aseptic manufacturing. While the full 2025 revised report is a paid publication via the PDA Bookstore
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- Preheating: Duplex stainless steels require preheating to prevent cracking and ensure proper weld penetration.
- Interpass Temperature Control: Controlling interpass temperature is crucial to prevent the formation of detrimental phases.
- Shielding Gas: The report provides guidance on selecting the correct shielding gas to prevent oxidation and ensure weld quality.
- Post-Weld Heat Treatment: PWHT is not always necessary, but it may be required for certain applications.
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Contents of PDA Technical Report 26
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PDA Technical Report 26, titled "Validation of Computer-Based Systems in Pharmaceutical and Biotechnology Industries," was published by the Parenteral Drug Association (PDA). The report provides a comprehensive guide on the validation of computer-based systems, including hardware, software, and firmware, used in the pharmaceutical and biotechnology industries. The report aims to ensure that these systems are reliable, secure, and compliant with regulatory requirements. The Parenteral Drug Association’s Technical Report No