As stated in the Code of Federal Regulations Title 21, Part 211 and USP <1072>, manufacturers of pharmaceutical products, especially in multi-product facilities, need to have a sound cleaning and sanitization program in place to prevent microbial, adventitious agent, or mycoplasma contamination. Current Good Manufacturing Practices (cGMPs) provide the framework for proper manufacturing of drug products, including the cleaning and maintenance of facilities and equipment. Knowledge of the disinfectant efficacy and having a validated program in place in your manufacturing facility is important for the prevention of rare contamination events.
Regulatory Considerations for Disinfectant Efficacy Studies
Texcell performs disinfectant efficacy studies in accordance with USP <1072>. Disinfectant efficacy studies demonstrate the effectiveness of a sanitizing agent against relevant microorganisms identified in a risk assessment performed by the drug manufacturer. The use of carrier testing, or coupon studies, is well established in evaluating the efficacy of a disinfectant against microbial, adventitious agent, or mycoplasma contamination.
The testing coupons are representative of surfaces in your cleanroom environment (Table 1). Coupons can be generally sourced if well-defined or obtained from your cleanroom manufacturer.
Selection of Disinfectants
The USP <1072> lists several points to consider when selecting a disinfectant for use in a pharmaceutical manufacturing environment. This includes the number of microorganisms to be controlled, the concentration and application method, and nature of the surface material being disinfectant. Some examples are shown in Table 2.
Additional Considerations for Study Design
The following should be considered during the planning and design stages of your disinfectant efficacy study:
- Identify relevant viruses to test based on your internal risk assessment.
- Identify the representative surfaces within the manufacturing facility
- Identify the disinfectants used in the facility’s cleaning and/or sanitization program
- Determine the contact time of each disinfectant on the representative surface
Determine the study controls (i.e. age of disinfectant) for each disinfectant and representative surface
Overview of Disinfectant Study Execution and Relevant Milestones
There are several steps in the execution of a disinfectant efficacy study that lead to its success (Figure 2). Texcell is diligent in communicating with the Sponsor at each phase and sharing data upon availability.
Preliminary Solution Phase Evaluation: What dilution scheme of the neutralizing agent is required to overcome assay toxicity and is required to quench virus inactivation?
Virus Recovery Evaluation: What is an effective methodology for virus recovery from the representative surface?
Preliminary Testing Evaluation: Are the testing materials compatible with the cell-based assay systems?
Virus Inactivation Evaluations: What is the effectiveness of the disinfectant in the presence of virus on the surface of each coupon? What is the effectiveness of the disinfectant beyond its shelf-life?
Results and Reporting: A detailed report containing the results of the disinfectant efficacy study is generated and submitted to the client.