A comparison is presented of data from simultaneous measurements of airborne particles by astandard slit-to-agar sampler (STA) and of fluorescent particles by a real-time bacterial detector, BioAerosol Monitoring System (BAMS) during an evaluation regarding emitted airborne particles of asurgical clothing system in a test chamber. Data from simultaneous orientating measurements ofairborne particles by a standard discrete particle counter are also discussed.

Cell and gene therapy manufacturing is characterized by complex processes and high costs, with each batch often being specific to an individual patient. The loss of even a single batch due to contamination or other issues can be devastating, both financially and for patient care. This highlights the critical need for reliable and rapid microbiological monitoring methods, such as Biofluorescent Particle Counters (BFPC), to efficiently measure sterility and reduce risk.

Advanced Environmental Monitoring and Troubleshooting with Bio-Fluorescent Particle Counters: Four Case Studies from the Process and Environmental Monitoring Methods Working Group

A new revision of the EU GMP Annex 1 was released by the European Commission in August of 2022. This long-awaited revision replaces that released in 2008 and comes two years after the release of the most recent draft version of the document.