Particle Measuring Systems’ BioCapt® Single Use (BCSU) technology has become a cornerstone of microbial environmental monitoring in advanced aseptic manufacturing, and its integration into IMA Life’s innovative TILE X fill finish solution for high-value pharmaceuticals marks a milestone achievement in innovation and partnership.
IMA Life’s TILE X is a groundbreaking gloveless, small batch RTU fill finish solution that uses advanced magnetic levitation to move vials or complete RTU nests with frictionless precision, eliminating particulate generation and enabling unparalleled sterility assurance. Designed for high value pharmaceuticals such as biopharmaceuticals, ATMPs, and cell and gene therapies, TILE X features a modular architecture in which each Grade A chamber executes a specific process phase — including RTU introduction, delidding, denesting, 100% check weighing, filling, stoppering and capping — while maintaining isolation through independently sealed, air tight modules. Its fully automated setup, human less positioning of critical parts, and integration with technologies like No Touch Transfer or streamlined decontamination, reduce cleanroom requirements and offer exceptional flexibility for modern aseptic manufacturing.
The BCSU technology integration into IMA Life’s TILE-X is destined to have a significant impact on pharmaceutical production.
IMA Life needed a microbial monitoring solution as innovative as their machine design: lightweight, aseptic, flexible and fully compatible with TILE-X’s unique airflow and movement paths. The BCSU quickly emerged as the perfect match. Its lightweight, Ready-To-Use format aligned seamlessly with TILE-X’s floating shuttle architecture. Externally validated VPHP resistance made it immediately suitable for integration, while its automatic handling capabilities enabled gloveless application.
The synergy strengthened with the BioCapt Single Use AutoM. Offering complete VPHP impermeability, the AutoM delivered an even more robust fit for IMA Life’s sterility and decontamination requirements. Its sealed magnetic cap design and full VPHP resistance provided confidence for pre-introduction into isolators and ensured complete compatibility with TILE-X’s decontamination cycle.
Today, every TILE-X is equipped with BCSUs as standard. Each line configuration can feature up to seven microbial sampling points, each fitted with two BCSUs, fourteen units in total. Customers can choose the classic BCSU or the fully VPHP-resistant AutoM depending on process needs. In either case, BCSU technology is now a key contributor to TILE-X’s environmental control strategy.
This partnership exemplifies excellence in both product design and cross-industry innovation. Particle Measuring Systems provided a microbial monitoring solution that has enhanced IMA Life’s revolutionary fill-finish solution, while IMA Life demonstrated the adaptability and performance of the BCSU family.
The result is a powerful fusion of technologies: magnetic levitation, modular aseptic architecture and cutting-edge microbial monitoring — together redefining what is possible in sterile pharmaceutical manufacturing.
Watch the TILE-X promotional video for more information: https://www.youtube.com/watch?v=-DoPefFFhgM
