INSIGHTS ON CRITICAL ENVIRONMENTS

CRITICAL ENVIRONMENT SOLUTIONS

  • Formulation and aseptic filling solutions are crucial at every stage of development. Consider a manufacturing partner who can address every challenge on the path from pre-clinical programs to commercialization.

  • Faciflex Express is a pre-designed cleanroom solution that delivers a commissioned cleanroom in as little as 6 months. Pre-designed standard cleanroom layouts are the next generation for snap together installation of modular panel systems. Faciliflex Express has 3 models 5k, 15k, and 30k representing cleanrooms of approximately 5,000, 15,000, and 30,000 square foot.

  • TSI’s cleanroom facility environmental monitoring products with built-in redundancy provide the confidence you need to reliably monitor critical processes and demonstrate compliance.

  • What Is Annex 1 and Why Is It Important? Annex 1 is a GMP document published by the European Commission and dedicated to the manufacturing of sterile products. All pharmaceutical companies that produce sterile products must comply with these regulations. The document is a joint initiative between the EMA and PIC/S.

  • Explore the benefits of a biofluorescent particle counter that provides real-time viable and total particle monitoring of critical environments, including the aseptic core, without the need for operator intervention.

FREE CLEANING VALIDATION E-BOOK

Learn how to employ science-, risk-, and statistics-based approaches to cleaning and cleaning validation at your facility with this free, 100-page e-book, written by a global team of cleaning validation experts, pharmaceutical toxicologists, statisticians, and Six Sigma professionals.