Az amerikai Excellims Corporation 2021. október 27-én “Establishing a rapid, compliant, specific cleaning validation protocol” címmel webinart szervez, melyben többek között összehasonlítják a HPLC és TOC technikákat a HPIMS (high-performance ion mobility spectrometry) lehetőségeivel. Az Excellims GA2200 HPIMS készülékéről a termék weboldalán tudhat meg többet: Excellims GA2200.
Az angol nyelvű, kb 45 perces előadáson a részvétel ingyenes, de regisztrációhoz kötött:
Featuring Igor Gorsky (Principal Process Validation Consultant @Valsource) as he discusses how to develop a fast cleaning validation protocol.
- How to evaluate different technologies to enable rapid cleaning validation programs
- Overview of the cleaning validation landscape including the regulatory environment
- How to establish a cleaning validation protocol
- The pros and cons of the different techniques available for cleaning validation including HPIMS (high-performance ion mobility spectrometry), HPLC and TOC
GMP Cleaning Validation and Verification
Cleaning validation plays an important role in reducing the possibility of product contamination and carryover from pharmaceutical manufacturing equipment. Cleaning verification demonstrates that the cleaning process adequately and consistently removes product residues, process residues and environmental contaminants from the manufacturing equipment, so that this equipment can be safely used for the manufacture of specified subsequent products. How quickly production equipment can be verified clean is a critical rate-limiting step of manufacturing efficiency. Historically, the analytical testing had been time-consuming, and can keep production equipment offline for days.
Emerging Cleaning Validation Technologies
The ability to perform fast analysis of a large number of samples to check for the presence of residual API and/or cleaning agents, is a growing need of the global pharmaceutical manufacturing industry. New process analytical technologies enable production of more pharmaceutical products faster and at a lower cost. The industry needs to evaluate and embed new technologies to improve cleaning validation cycle times and reduce costs. Ion mobility spectrometry (IMS) can enable rapid cleaning verification programs.