INSIGHTS ON CRITICAL ENVIRONMENTS

CRITICAL ENVIRONMENT SOLUTIONS

  • Biofluorescent Particle Counters (BFPC), like the TSI BioTrak® Real-Time Viable Particle Counter, are an alternative microbiological method that serves as the solution for Annex 1 compliance and Pharma 4.0 implementation.

  • A streamlined transfer approach brings monitoring plates into controlled areas without decontamination delays. With plates kept organized and accessible, teams can maintain productivity.

  • The MiniCapt® Mobile Microbial Air Sampler from Particle Measuring Systems (PMS) is an innovative, light and mobile viable sampler. It simplifies the job of microbial air sampling by applying modern data management capabilities that save time and reduce operator error in air sampling data.

  • Brand new Lytzen depyrogenation oven, model LDF-380. The Lytzen LDF-380 is a high-performance depyrogenation oven designed for ISO Class 5 (formerly Class 100) cleanliness throughout the cycle. With a fully welded stainless steel chamber, it operates at up to 280°C for effective pyrogen removal. Its forced air convection system ensures uniform heat distribution, while a semi-automatic flush door enhances ease of use. Serial# A20221074, built 2022. The unit is already packaged, and installation is included with the sale for seamless setup and operation.

  • Environmental monitoring ensures cleanroom certification, microbial control, utility testing, digital data management, and rapid remediation to maintain cGMP compliance and safeguard product integrity.

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