Issue 4, 2010

Validation of cleaning of pharmaceutical manufacturing equipment, illustrated by determination of cephradine residues

Abstract

The systematic approach developed to assess the amount of residues left on manufacturing equipment surfaces from product carryover is known as cleaning validation. Current trends have seen increasing demand for rapid sample analysis time along with low detection limits for verification of cleaning validation samples. A total organic carbon (TOC) method is sensitive to the ppb range and is less time consuming than high performance liquid chromatography (HPLC). The purpose of this study is to demonstrate how to develop and validate a TOC method for cleaning applications. Validation of the cleaning procedures for manufacturing or processing equipment has been presented in this paper. A sensitive and reproducible method was developed and validated for the determination of cephradine in swab samples. The method for determining residues of cephradine on manufacturing equipment surfaces was validated for precision, linearity, accuracy, limit of quantification and % recovery of a potential contaminant. The sampling procedure using cotton swabs was also validated. A mean recovery from stainless steel plate close to 78% was obtained. The assay was linear over the concentration range of 30 to 600 ng ml−1 concentration (R ≈ 0.9987). The calculated limit of contamination value was less than 315 μg cm−2, during three consecutive cleaning trials.

Graphical abstract: Validation of cleaning of pharmaceutical manufacturing equipment, illustrated by determination of cephradine residues

Article information

Article type
Paper
Submitted
30 Nov 2009
Accepted
02 Feb 2010
First published
22 Feb 2010

Anal. Methods, 2010,2, 397-401

Validation of cleaning of pharmaceutical manufacturing equipment, illustrated by determination of cephradine residues

S. S. Sajid, M. S. Arayne and N. Sultana, Anal. Methods, 2010, 2, 397 DOI: 10.1039/B9AY00278B

To request permission to reproduce material from this article, please go to the Copyright Clearance Center request page.

If you are an author contributing to an RSC publication, you do not need to request permission provided correct acknowledgement is given.

If you are the author of this article, you do not need to request permission to reproduce figures and diagrams provided correct acknowledgement is given. If you want to reproduce the whole article in a third-party publication (excluding your thesis/dissertation for which permission is not required) please go to the Copyright Clearance Center request page.

Read more about how to correctly acknowledge RSC content.

Social activity

Spotlight

Advertisements