50 Years, 50 Articles

Cleaning And Disinfection Program Part Of The Lifecycle Approach: A Risk Based Rather Arbitrarily Imposed Approach

Authors:

Walid El Azab

Keywords:

cleaning, disinfection, lifecycle approach, cGMP, risk based approach, microbiology

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.

Article:

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 zalong 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 CFR211.192) are amongst the top 10 most observed deficiencies by the FDA since
2012 (6). The situation in Europe is not any different based on recent UK MHRA (Medicines Healthcare products Regulation Agency) deficiencies observed, and the
noncompliance reports handed out by European Inspectors (7-9).

The objective of the article is first to present the different regulatory requirements and guidance regarding disinfectant rotation. Secondly, the article seeks to answer the
question "Is the rotation of more than one disinfectant along with a sporicidal agent mandatory for cGMP compliance?". To be able to fully answer the question, the process
of establishing the number of disinfectants (one or more) will be discussed. 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




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