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Investigation of an alternative approach for real-time cleaning verification in the pharmaceutical industry

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Abstract

Within the pharmaceutical industry, it is a regulatory requirement to ensure that pharmaceutical drug manufacturing equipment is clean prior to use. Cleaning processes of manufacturing equipment are performed using a “validated” process and subsequently verified since inadequate cleaning can result in a contaminated or adulterated product. Historically, cleanliness of equipment within Drug Substance/Product/Active Pharmaceutical Ingredient (API) manufacturing is validated and verified using direct swabbing of the equipment and subsequent analytical testing of the swab extract. In this study, a novel approach has been evaluated using a number of innovative technologies and techniques to develop and validate a methodology based on an in situ hand-held Process Analytical Technology (PAT) to verify manufacturing equipment cleanliness and eliminate swabbing and associated off-line laboratory testing. Specular reflectance Mid Infrared (Mid-IR) spectroscopy was used to detect and quantify surface residue. It is expected that this analytical technique will allow the elimination or reduction of the number of swabs and subsequent off-line analytical testing required during cleaning verification of manufacturing equipment in the pharmaceutical and biopharmaceutical industry. This study was focused on the development and validation of a Mid-IR based calibration model. The results indicate that surface a residue of 0.19 μg cm−2 for a specific molecule is detectable using a specular reflectance Mid-IR technique.

Graphical abstract: Investigation of an alternative approach for real-time cleaning verification in the pharmaceutical industry

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Article information


Submitted
17 Jun 2020
Accepted
31 Aug 2020
First published
04 Sep 2020

Analyst, 2020, Advance Article
Article type
Paper

Investigation of an alternative approach for real-time cleaning verification in the pharmaceutical industry

A. Sarwar, C. McSweeney, M. Smith, J. Timmermans and E. Moore, Analyst, 2020, Advance Article , DOI: 10.1039/D0AN01219J

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