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JVT Article: Laboratory Studies In Cleaning Validation

Price: $19.99
tax free
Item Number: JA1Q1071
Author: Paul Pluta

EXECUTIVE SUMMARY
Laboratory studies are an important part of a cleaning validation program. Studies discussed are those in addition to typical laboratory quantitative analysis of swab or rinse samples. “Benchmarking” respondents commented on the value of laboratory studies, the types of laboratory apparatuses used for these studies and the applications of these studies.

Validation practitioners wholeheartedly agreed on the usefulness of cleaning laboratory studies. Cleaning laboratory studies are helpful for understanding and providing a technical rationale for the cleaning process and activities associated with cleaning validation. Depending on the complexity of the large-scale cleaning process, information from laboratory studies may be directly applicable to the large scale process.

Various designs of apparatuses used in laboratory studies and techniques for preparation of dried residue were described. The choice of apparatus design and technique in residue preparation should attempt to simulate the actual dried residue and cleaning method used in large-scale cleaning processes and equipment.

Laboratory studies include basic studies to determine analyte stability and solubility. Stability and solubility studies are vital to a technical cleaning process. Laboratory studies also included cleaning process development studies such as cleaning agent selection, concentration, effect of dirty hold time, and other applications. Studies to determine the visual detection limit of dried product residue were also reported by respondents.

Laboratory studies in support of cleaning procedures and cleaning validation were highly recommended by respondents. These studies are extremely useful in providing cleaning process understanding and technical rationale for decisions related to cleaning.

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