Journal of Pharmaceutical Research

Abstract

Objective: Cross-contamination is a major problem in multiproduct manufacturing facilities. This can lead to major problems in a bulk drug manufacturing facility, as cross-contamination in one batch may end up in several batches. Hence, cleaning validation is of utmost importance in these facilities. The present study was undertaken to develop and validate the cleaning process for the changeover products between parental dosage forms of cloxacillin sodium and amoxycillin and potassium clavulanate where there is a risk of potential hazards of cross contamination Method: Cloxacillin Sodium was selected using a cross-matrix approach with a 420 mg MACO value. The HPLC method was validated and recovery studies were conducted using swab sampling. The equipment was cleaned and samples were collected for chemical and microbial contamination. Findings: Analytical method validation for Cloxacillin Sodium was carried out, and the data were found to be well within the limits. The swab recovery rate for Cloxacillin Sodium was found to be 89.67 % (Limit: NLT 70%). The swab & rinse method values were 5.6868 mg/swab and 28.14 mg / Rinse and the values were well within the acceptance limit of MACO (420 mg). The maximum total viable count was 0 cfu/swab (limit: 1 cfu /swab). Novelty: All the chemical and microbiological results met the acceptance criteria. It can be concluded that the cleaning procedure used in manufacturing plants was satisfactory.

Keywords: Cleaning validation, Swab recovery method, Cloxacillin sodium, Cross­matrix approach