Total organic carbon (VCSN and VWP) and HPLC analysis for cleaning validation in a pharmaceutical pilot plant.
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.
Queralt
M
M
Pharmacy Department, University of Barcelona.
García-Montoya
E
E
Pérez-Lozano
P
P
Suñé-Negre
J M
JM
Miñarro
M
M
Ticó
J R
JR
D002851:Chromatography, High Pressure Liquid; D004340:Drug Contamination / Q000517:prevention & control*; D004345:Drug Industry; D004866:Equipment Contamination / Q000517:prevention & control*; D004867:Equipment Design; D005160:Facility Design and Construction; D009930:Organic Chemicals / Q000032:analysis*; D010084:Oxidation-Reduction; D015203:Reproducibility of Results; D013678:Technology, Pharmaceutical / Q000295:instrumentation / Q000379:methods* / Q000592:standards
D009930:Organic Chemicals