Development of a User Requirement Specification (URS) for a Biofluorescent Particle Counter (BFPC) for Surface and...

Pharmaceutical manufacturers are implementing BFPC technology for in-process monitoring and control of unidirectional air flow in aseptic filling operations to improve cleanroom operations, thus enhancing sterility assurance and product quality. Continuous real-time monitoring is able to reduce the industry's reliance of growth-based methods for 5 to 7-day incubation periods to obtain results. A similar approach to surface and personnel monitoring is necessary to complete the environmental monitoring review for GMP batch release without the delay due to the traditional methods.This poster will offer an overview of what the M3 collaboration expects the vendor community to include when developing instrumentation for BFPC surface monitoring as part of the User Requirement Specification (URS). Key elements include the rationale for development, device description, business case, validation and calibration parameters, and desirable features.A major consideration is the ability to count Auto-fluorescent Units (AFU) per 25 cm² on both flat facility surfaces and irregular ones (for example, needles, stopper tracks, stopper insertion pistons). This may require two sampling devices rather than one. The aim of our initiative is to streamline the development of a BFPC surface monitoring system; feedback on the value of the proposed URS will be gathered during the poster session.