RT Journal Article
SR Electronic
T1 Total Organic Carbon (VCSN and VWP) and HPLC Analysis for Cleaning Validation in a Pharmaceutical Pilot Plant
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 42
OP 57
VO 63
IS 1
A1 M. Queralt
A1 E. García-Montoya
A1 P. Pérez-Lozano
A1 J. M. Suñé-Negre
A1 M. Miñarro
A1 J. R. Ticó
YR 2009
UL http://journal.pda.org/content/63/1/42.abstract
AB This paper presents a useful method using total organic carbon analyzers employing both combustion and wet oxidation for validating equipment cleaning procedures and verifying cleaning in a pharmaceutical pilot plant. The results are compared with those obtained using high-performance liquid chromatography. The study summarizes the initial steps that should be taken into account and focuses particularly on the solutions to some of the most critical considerations (e.g., glass material, detection and quantification limits, recovery). Also described are the calculation of control limits and the good results obtained.