Table of Contents

LCMSMS Method for Beta-lactam Facility Decontamination

Globally there is a trend that manufacturing facilities for Beta-lactam antibiotics are being converted for the manufacture of Cephalosporin products. An important part of this changeover is to establish that there are no residues of Beta-lactams in the facility and no cross contamination of the new product range. We have developed and validated a simultaneous method to support such facility decontamination studies. We can support clients with sampling protocols and analysis of swab samples from cleaning validation and samples of final products to establish the absence of the Beta-Lactam products earlier manufactured in the facility. Our current method can detect 12 of the most common Beta-lactams at a level of 2.5 ng/gm in a single run. The method can be further adapted to your product range and duly validated. Please feel free to contact us using the Quick Query form on this page to request relevant literature and free expert consultation.

Leave a Reply

Enter the Captcha