Dry Heat Sterilization - New USP General Chapter <1229.8>
Register now for ECA's GMP Newsletter
According to a proposal in the Pharmacopeial Forum 39 (3) the USP General Chapter <1211> "Sterilization and Sterility Assurance of Compendial Articles" will be separated in several individual chapters. One of these chapters - <1229.8> - will address "Dry Heat Sterilization".
This chapter will provide an overview of dry heat sterilization and its validation. It describes dry heat sterilization in the range of 160 - 190° C with the objective of sterilization rather than depyrogenation. Topics that will be covered are:
- Sterilization Cycle Control
- Validation of Dry Heat Sterilization
- Equipment Qualification
- Empty Chamber Temperature Distribution
- Component Mapping
- Load Mapping
- Biological Indicators
- Heat Penetration and Microbiological Challenge
- Routine Process Control
The Comment deadline is end of July 2013.
You can find more information at the Pharmacopeial Forum.
Source: USP
http://www.usp.org
Conference Recommendations
Related GMP News
03/04/2024
GMP Conferences by Topics
- General Quality Assurance and GMP Compliance Topics
- Hygiene
- General Microbiology Topics
- Regulatory Affairs
- Development
- General Analytics Topics
- Good Distribution Practice
- Sterile Manufacturing
- Computer Validation
- General Qualification/Validation Topics
- General Engineering Topics
- APIs/Excipients
- GMP Basic Training Courses
- Medical Devices and Combination Products
- Packaging and Packaging Material
- Data Integrity
- Qualified Person (QP)
- GMP Auditing
- Documentation
- Cleaning Validation
- General IT Compliance Topics
- Impurities
- OOS / OOE / OOT
- Material Testing
- Validation of Analytical Methods
- Analytical Instrument Qualification
- Stability Testing
- Microbiological Testing
- Technology
- General Manufacturing Topics
- Solid Dosage Forms/Semi-Solid Dosage Forms
- Biotechnology/Blood/ATMP
- Herbal Drug Products/Cannabis/Radiopharmaceuticals
- Others