Walid El Azab
Technical Service Manager, STERIS Life Science

Abstract

Is the rotation of more than one disinfectant along with a sporicidal agent mandatory for cGMP compliance? The article will present and analyze the regulatory requirements related to contamination control programs then dive into the requirements for cleaning and disinfection programs, including disinfectant rotation along with a sporicidal agent. The article discusses the process of selection and number of disinfecting agents to be used, the frequency of application, and rotation of (one or more) disinfectants along with a sporicidal agent. Finally, the article reaffirms the importance of periodically reviewing microbial data and auditing practices to confirm the effectiveness of the cleaning and disinfection program including the disinfectant rotation and frequency choice.

INTRODUCTION

Cleaning and microbial contamination control are critical focus areas in the (bio)pharmaceutical and medical device industries. Robust cleaning and disinfection programs are required to prevent adulteration, cross-contamination, and microbial contamination of products. Consequently, the selection and number of disinfecting agents used, the frequency of application, and the rotation of (one or more) disinfectants along with a sporicidal agent should be scientifically justified by a formal microbial risk analysis (MRA). The MRA and the chosen cleaning and disinfection program should be supported by periodic review of relevant environmental monitoring (EM) data, and regular auditing of the cleaning and disinfection programs.  

Inadequate cleaning and disinfection programs cause significant risk to patient safety, financial loss to the company and product recalls (1-5). Recurring microbial contamination generally results from inadequate cleaning and disinfection procedures associated with an ineffective root-cause investigation. Control of microbiological contamination and root-cause investigation (see CFR211.113 a and b, and CFR211.19 ...