Chemistry and Microbiology Perspectives on Cleaning Validations and Disinfectant Efficacy Studies

Good Manufacturing Practice (GMP) requires manufacturers of finished bio/pharmaceutical products to effectively clean their facilities and equipment prior to production and disinfect regularly to ensure product safety.

The key to successful facility cleaning is understanding the complete process, including the unique differences between materials cleaning validation and disinfectant efficacy studies, how the two processes are related and the challenges associated with each.

An effective cleaning, disinfection and monitoring program includes three distinct activities:

1. Establishing that the cleaning program is effective in removing any product without leaving chemical cleaning agent residues.
2. Ensuring that any disinfectants used in the processes are effective at decreasing or eliminating the microorganism levels on the surfaces and equipment.
3. Performing chemical and microbiological monitoring to confirm that chemical residues and bioburden are within acceptable limits for the area.

Establishing the effectiveness of disinfectants is an important component of a facility cleaning and environmental monitoring program, though the variables related to disinfection of surfaces, along with the time and labor required to conduct these studies, can make the process complex.

During this presentation, you will learn how to establish the best and most cost-effective approach to a cleaning, disinfection and monitoring program, including:

• Best practices for chemistry cleaning validation.
• Best practices for microbiology cleaning validation.
• Understanding the difference between cleaning validation and disinfectant studies and how they relate.
• Challenges and variables related to disinfection of surfaces.

Speakers

Harolyn M. Clow, M.S., SM (NRCM), Manager, Pharmaceutical Microbiology, Eurofins Lancaster Laboratories

Ms. Clow has over 25 years of experience in Pharmaceutical microbiology in manufacturing, biotech and contract laboratory operations and has worked with sterile products, non-sterile products and facility support systems in the Pharmaceutical Microbiology department at Eurofins Lancaster Laboratories since 1991. As Manager of the Facility Validation and Support area in Pharmaceutical Microbiology, Ms. Clow oversees the design and execution of disinfectant efficacy evaluations, environmental monitoring programs and water system qualifications. She earned a M.S. in quality assurance and regulatory affairs from Temple University and a B.S. in microbiology from Colorado State University.

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Anthony J. Langione, Senior Chemist, Method Development & Validation, Eurofins Lancaster Laboratories

With Eurofins Lancaster Laboratories’ Method Development & Validation group since 2008, Mr. Langione has extensive experience developing and validating analytical testing methods for drug products and raw materials utilizing a multitude of instrumentation and techniques. As a Senior Chemist, he is directly involved in all aspects of cleaning validation studies including client consultation, method development, validation and routine sample analysis. He earned a B.S. in chemistry from The Pennsylvania State University.

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