Cleaning Validation by TOC Analyzer

To ensure quality control and safety in manufacturing facilities within the pharmaceutical industry, it is important that cleaning validation be conducted following the cleaning of production-related equipment. Cleaning validation ensures that the quantity of residual substances collected from the surfaces of the equipment is within permissible limit. Depending on the sampling method and measurement method used for this cleaning validation using a TOC analyzer, the following 3 types of methods are available.(1) Rinse sampling - TOC measurement method (2) Swab sampling - aqueous extraction - TOC measurement method (3) Swab sampling - direct combustion carbonmeasurement method Here we introduce the features of each of these methods, using the TOC-LCPH total organic carbon analyzer in the measurement of residual pharmaceutical products and their constituent substances.

Content Type:
Application
Document Number:
LAAN-A-TC-E017
Product Type:
Total Organic Carbon Analysis, TOC Analysis
Keywords:
TOC,Swab,Total Organic Carbon Analyzer,cleaning validation., Pharmaceutical, Life Science, Development (Formulation, Scale-up, Method development), Manufacturing, QA/QC, TOC-L
Language:
English
File Name:
jph511002.pdf
File Size:
1,340kb

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For Research Use Only. Not for use in diagnostic procedures.

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