White Paper: Surface Challenge Quantitative Disinfectant Efficacy Test (DET) for Pharmaceutical and Biopharmaceutical Facilities

White Paper: Surface Challenge Quantitative Disinfectant Efficacy Test (DET) for Pharmaceutical and Biopharmaceutical Facilities

Author: Angela Hollingsworth – Microbac Laboratories Inc. Director of Microbiology at Microbac Sterling, Virginia

Validation of sanitizing and disinfectant agents for effectiveness against potential contaminating micro-organisms (bacteria, spores, viruses, etc.) is increasingly an area of concern to manufacturers and regulatory agencies alike. 

The surface validation protocol is based on USP Chapter <1072> and other related method standards; and is customized based on your specific applications. This type of validation is required to demonstrate the efficacy of a disinfectant and/or sanitizer within a pharmaceutical or biopharmaceutical manufacturing environment.

As a manufacturing facility, all of the aspects that devise your cleaning program need to be thought through to ensure that your program is effective. Common materials selected for testing include stainless steel (hoods, counters, etc.), polyvinyl chloride (curtain materials), and epoxy (floors) and much more. Additional suggestions for other surfaces are also given in the USP <1072> document.

A brief summary of the method includes that the test coupons or surfaces are challenged with a microbial, viral or spore suspension and then dried. These suspensions will include repository isolates as well as environmental isolates from your manufacturing facility. Each coupon is then treated with the selected disinfectant agent. Application methods of the disinfectant to the coupon surface can vary greatly and are adjusted within the laboratory to simulate actual use conditions. These application methods may include spray, wipe, or mopping. After the stipulated contact time, the surfaces are sampled using a neutralizing solution and cultured. Worst-case conditions, such as using an aged disinfectant, shortest contact time, hard-water as diluent and testing chemical action alone without mechanical wiping, etc., shall be considered in the design and execution of a surface coupon disinfectant efficacy test. All test evaluations are usually performed in triplicate and evaluated quantitatively. Standard controls, including a recovery validation procedure are included to validate the study. A detailed protocol will be provided upon agreement and fulfillment of the terms and conditions.

The selection of a testing laboratory to conduct these validation trials must take into account the experience, performance, quality, and credibility of the contract laboratory. Microbac Laboratories, Inc. is the ideal choice as test performance, data integrity and quality assurance are the foundation of all tests performed at our laboratories. Microbac’s reputation was firmly rooted more than 50 years ago because of our resolute commitment to exceptional laboratory analysis and outstanding customer service. Today our company continues to be universally recognized within the disinfectant/sanitizer, sterilant, and bioprocess industry, a distinction derived, and nurtured, by providing the best services possible to all our clients.

Contact us today and a customized proposal will be generated based on your testing requirements. Our labs are fully compliant with GLP and cGMP for FDA submissions; and we are also accredited with ISO 17025. We look forward to working with you.

Leave a Reply

Your email address will not be published. Required fields are marked *