Practical Applications of Biofluorescent Particle Counting in Environmental Monitoring Investigations

A Discussion on Bio-Fluorescent Particle Counters: Summary of the Process and Environmental Monitoring Methods Working Group Meeting with the FDA Emerging Technology Team

“…BFPC systems for air and water have been used successfully in non-good manufacturing practice (non-GMP) monitoring applications by a number of pharmaceutical companies. Some of these applications or use cases have recently been presented in journal articles and webinars (3)(4)(5)(6)(7)(8)(9)(10)(11). BFPC have not yet been broadly adopted for GMP applications despite the benefits described above.…”

Application of Biofluorescent Particle Counters for Real-Time Bioburden Control in Aseptic Cleanroom Manufacturing

“…A direct comparison of BFPC-measured values with CFUs counted on agar plates or strips is hardly possible, as described by several scientists [19,[24][25][26]. The reason for this is the dependency on possible growth on agar plates with CFU methods.…”

“…This is, in fact a big advantage of the BFPC systems, as an immediate overall MCP result can be obtained and knowledge of the general bioburden status of a cleanroom can be provided. Though the specific species of microbes is not known at this point, this is still valuable not only during pharmaceutical operations, but also for an evaluation of the operational readiness of a cleanroom in preparation for commissioning and qualification [25]. It would minimize the time required for finding bioburden leaks in the cleanroom installation [2,19,27].…”

Case study on the environmental monitoring for biological manufacturing using Time-lapse Shadow Image Analysis

“…Obviously, the paradigm of microbiological test implementation is shifting from the traditional visual colony count method (VCC) to RMMs to maintain and improve the level of cleanliness at low bioburden in the manufacturing facility, as well as the shift to isolators and restricted access barriers (RABS) from conventional cleanrooms. Recently, the practical applications of RMMs to the environmental monitoring for the manufacturing site of sterile products has been reported [14]. Also, both bioburden control for bulk drug substance and environmental monitoring for the manufacturing facilities have been reported for biological manufacturing [15][16][17][18].…”